Abstract
Background
Available evidence regarding the effect of erector spinae plane block (ESPB) as a component of multimodal analgesia on postoperative quality of recovery after laparoscopic colon cancer surgery remains inconsistent.
Purpose
This trial aimed to determine whether adding single-shot bilateral ESPB to a multimodal analgesic regimen would improve early postoperative quality of recovery.
Methods
In this prospective, randomized, outcome-assessor-blinded controlled trial, 60 participants undergoing laparoscopic radical resection of colon cancer under general anesthesia were randomly assigned (1:1) to receive the ultrasound-guided bilateral single-shot ESPB at the T12 level with 20 mL of 0.25% ropivacaine on each side or a sham procedure before anesthesia induction. The primary outcome was the QoR-15 score at 24 h postoperatively. Secondary outcomes included mean intraoperative remifentanil infusion rate, postoperative sufentanil consumption, postoperative pain scores, time to first patient-controlled intravenous analgesia demand, time to first ambulation, time to first flatus, adverse events, and patient satisfaction.
Results
Five participants were excluded after randomization; therefore, data from 55 participants were included in the per-protocol analysis. The adjusted mean QoR-15 score at 24 h postoperatively was 126.2 in the ESPB group and 120.3 in the control group, with an adjusted mean difference of 5.88 points (95% confidence interval, 4.02–7.74; p<0.001). Compared with the control group, the ESPB group had a lower intraoperative remifentanil use (p<0.001) and a shorter time to first ambulation (p=0.007). No significant between-group differences were observed in other secondary outcomes.
Conclusion
Adding single-shot bilateral ESPB to a multimodal analgesic regimen was associated with an improved quality of early postoperative recovery, a lower intraoperative remifentanil use and earlier ambulation in patients undergoing laparoscopic colon cancer surgery. Larger multicenter studies are warranted to confirm these findings.
Trial Registration
Chinese Clinical Trial Registry, ChiCTR2300073180; date of registration: July 4, 2023.
Keywords: erector spinae plane block, laparoscopic surgery, colon cancer resection, multimodal analgesia, enhanced recovery after surgery
Introduction
Colorectal cancer is the third most common malignancy worldwide, with approximately 400,000 new cases diagnosed annually in China alone.1 In current practice, laparoscopic radical resection is one of the standard treatment modalities for this disease. Although laparoscopic colorectal resection is minimally invasive, it may cause moderate to severe postoperative pain for several days due to peritoneal stretching, electrocautery-induced tissue injury, muscle spasms, inflammation, and ischemic stimuli.2 Available evidence indicates that poorly controlled pain after major abdominal surgery is associated with increased risks of complications, delayed recovery, and prolonged hospital stay.3
The current Enhanced Recovery After Surgery (ERAS) practices for colorectal surgery emphasize multidisciplinary collaboration and use of multimodal strategies in perioperative care to accelerate postoperative function recovery and improve patient outcomes.4 As a crucial component of ERAS practices, well-controlled pain may reduce physiological stress responses, alleviate anxiety and depression, shorten the duration of functional impairments, and ultimately promote rapid postoperative recovery and improve patient satisfaction. Multimodal analgesia refers to the combined use of analgesic interventions with different mechanisms of action, such as non-opioid analgesics, local infiltration, regional analgesic techniques, and opioids when required.5 The purpose of this approach is to improve analgesic efficacy while reducing opioid exposure and opioid-related adverse effects. Epidural analgesia is effective for pain control after laparoscopic colorectal surgery, but it is often limited by potential adverse events, such as hypotension, urinary retention, and muscle weakness due to extensive sympathetic and motor blocks. These issues are particularly significant in elderly patients or those with compromised cardiovascular function. In contrast, regional analgesic techniques, such as the transversus abdominis plane block (TAPB) and erector spinae plane block (ESPB), primarily targeting somatic nerve blocks without significant sympathetic and motor blocks.6,7 Thus, the current ERAS practices recommend the use of regional analgesia techniques as components of multimodal analgesic strategies.
Emerging evidence suggests that ESPB is an effective analgesic technique in patients undergoing laparoscopic procedures, with reported benefits including improved pain control, reduced perioperative opioid consumption, and a lower incidence of postoperative nausea and vomiting (PONV).8–10 However, available literature provides inconsistent evidence supporting the use of ESPB as a component of multimodal analgesic regimens to improve the quality of recovery after laparoscopic colorectal cancer surgery.11,12 To address this important clinical issue, this prospective, randomized controlled trial was designed to further determine the effect of adding a single-shot bilateral ESPB to the multimodal analgesic regimen on early postoperative recovery in patients undergoing laparoscopic colon cancer surgery.
Methods
Study Design and Setting
This randomized, controlled, single-center clinical trial was conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines and principles of the Declaration of Helsinki. The study was conducted at Beijing Friendship Hospital. The protocol was reviewed and approved by the institutional ethics committee on April 12, 2023 (2023-P2-062-02). Prior to patient enrollment, the trial protocol was registered with the Chinese Clinical Trial Registry on July 4, 2023 (Chictr.org.cn; Identifier: ChiCTR2300073180). Written informed consent was obtained from all the participants after they received detailed information regarding the study objectives, procedures, potential benefits, and risks.
Participants
All participants underwent comprehensive preoperative evaluation according to institutional standards. Inclusion criteria included adults aged 35–65 years scheduled for elective laparoscopic radical resection of colon cancer, American Society of Anesthesiologists (ASA) physical status classification I–II, and the ability to understand and sign informed consent. The exclusion criteria were inability or unwillingness to provide informed consent; refusal to participate in the study or use of the ESPB; inability to maintain a lateral decubitus position for ESPB; infection at the ESPB site; pregnancy; psychological or psychiatric disorders; a history of chronic pain or continuous analgesic use within 3 months preoperatively; allergy to ropivacaine; hepatic or renal dysfunction affecting drug metabolism; and conditions that may mimic local anesthetic toxicity. Eligible participants were informed that they had the right to withdraw from the study at any given time. Patients were also excluded from the study if any of the following conditions occurred: intraoperative conversion to open surgery, unplanned admission to the ICU, or loss to follow-up.
Demographic data of eligible participants, including age, sex, height, weight, body mass index, ASA physical status classification, comorbidities, and preoperative laboratory results, were recorded during the initial evaluation.
Randomization and Blinding
This was an outcome-assessor-blinded randomized controlled trial. Participants were randomly allocated in a 1:1 ratio to the ESPB group or the control group using block randomization with a block size of 4. The random sequence was generated using Random Allocation Software version 1.0 by an investigator who was not involved in participant enrollment, intervention, perioperative management, or outcome assessment. Group assignments were concealed in sequentially numbered, opaque, sealed envelopes, which were opened immediately before the intervention.
Because of the nature of the interventions, the anesthesiologist performing the ESPB or sham procedure was not blinded to group allocation and did not participate in intraoperative management, postoperative care, or outcome assessment. Participants in the control group received a sham procedure consisting of lateral positioning, skin disinfection, and ultrasound probe placement, but without skin infiltration, needle puncture, or local anesthetic injection. Participants were not explicitly informed of their group allocation. Postoperative outcome assessors responsible for data collection and QoR-15 measurement were blinded to group allocation throughout the study period.
Study Protocol and Implementation
All participants fasted for 6 h before surgery. Before entering the operating room, ultrasound-guided subclavian venous catheterization was performed in the ultrasound department under local anesthesia and standard monitoring according to institutional practice, and peripheral venous access was secured. No sedatives or systemic analgesics were administered before the ESPB or sham procedure. Upon arrival in the operating room, standard monitoring was initiated, including noninvasive blood pressure, heart rate, pulse oximetry, electrocardiography, invasive arterial pressure, and bispectral index. Lactated Ringer’s solution was administered through peripheral and central venous lines according to routine clinical practice.
After baseline hemodynamic data were obtained, participants were placed in the lateral decubitus position for the assigned intervention under strict aseptic conditions. By using a Mindray TE7 ultrasound system equipped with an L14-6Ns high-frequency linear-array transducer (Mindray Medical, Shenzhen, China), the ultrasound-guided bilateral ESPB was performed at the T12 vertebral level by an independent anesthesiologist who was experienced in this technique. The probe was initially placed in the sagittal orientation to identify the T12 spinous process and then moved approximately 2–3 cm lateral to the midline to visualize the transverse process and overlying erector spinae muscle. In the ESPB group, using an in-plane approach from cephalad to caudal, the needle was advanced to the fascial plane deep to the erector spinae muscle. After hydrodissection with 0.5–1.0 mL of normal saline to confirm correct needle tip position, 20 mL of 0.25% ropivacaine was injected on each side, for a total volume of 40 mL. Successful injection was defined by separation of the erector spinae muscle from the transverse process and visible craniocaudal spread of local anesthetic in the erector spinae plane (Figure 1). Participants in the control group received a sham procedure with the same lateral positioning, skin disinfection, and ultrasound probe placement, but without skin infiltration, needle puncture, or local anesthetic injection. The sensory extent and onset time of ESPB were not formally assessed before induction of general anesthesia in order to avoid delay of operating room workflow and to maintain consistency in perioperative procedures.
Figure 1.
The ultrasound-guided erector spinae plane block by an in-plane technique. The arrow indicates the direction of needle advancement and correct position in the deep plane of the erector spinae muscle at the T12 level.
General anesthesia was induced with intravenous sufentanil 0.3 μg/kg, etomidate 0.3 mg/kg, and cisatracurium besylate 0.15 mg/kg. After tracheal intubation, mechanical ventilation was initiated using a volume-controlled model with a tidal volume of 6–8 mL/kg, a respiratory rate of 12–16 breaths/min, and an inspiratory/expiratory ratio of 1:2. Ventilatory parameters were adjusted to maintain PETCO2 at 35–45 mmHg. Before skin incision, flurbiprofen axetil 50 mg was administered intravenously for preemptive analgesia. Anesthesia was maintained with continuous infusions of propofol 4–6 mg/kg/h and remifentanil 0.15–0.3 μg/kg/min, targeting a BIS value of 40–60. Additional cisatracurium was administered as required.
Intraoperative remifentanil infusion was also adjusted according to hemodynamic responses and clinical signs of nociception. Hypotension, defined as mean arterial pressure <65 mmHg or a decrease of >20% from baseline, was treated with fluid administration and/or vasopressors according to routine clinical practice. Bradycardia, defined as heart rate <50 beats/min with hemodynamic instability, was treated with atropine. Hypertension or tachycardia judged to be related to inadequate analgesia was managed by adjusting the depth of anesthesia and remifentanil infusion.
At the end of surgery, anesthetic infusions were discontinued, 10 mL of 0.5% ropivacaine was injected into the trocar sites and incision area for local analgesia, and 5 mg tropisetron was administered intravenously for PONV prophylaxis. After tracheal extubation, patients were transferred to the post-anesthesia care unit and returned to the ward once an Aldrete score of 9 or more was achieved.
Postoperative pain was assessed using an 11-point visual analog scale at 24 h postoperatively and whenever patients requested additional analgesia. Postoperative analgesia consisted of intravenous flurbiprofen axetil 50 mg every 12 h for 3 days and PCIA with sufentanil 2 μg/kg diluted to 100 mL with normal saline. The PCIA settings included a bolus dose of 2 mL, a 15-min lockout interval, and a maximum dose of 8 mL/h. The analgesic target was a VAS score <4 at rest. If the VAS score remained ≥4 despite PCIA, flurbiprofen axetil 50 mg was administered intravenously as rescue analgesia. The total daily dose of flurbiprofen axetil, including scheduled and rescue administration, did not exceed 150 mg.
Outcome Measurements
The primary outcome was the QoR-15 score at 24 h postoperatively, assessed using the Quality of Recovery-15 questionnaire.13 Secondary outcomes included mean intraoperative remifentanil infusion rate, postoperative sufentanil consumption via PCIA, VAS pain score at 24 h postoperatively, time to first PCIA demand, time to first ambulation, time to first flatus, patient satisfaction at 72 h postoperatively, and postoperative adverse events, including PONV, pruritus, low back pain, respiratory depression, hypoxemia, and local anesthetic toxicity.
Surgery type, surgical duration, and anesthesia duration were recorded as perioperative clinical characteristics rather than secondary outcomes. Patient satisfaction was assessed at 72 h postoperatively using a 0–10 numerical rating scale, ranging from 0 = very unsatisfied to 10 = very satisfied. The mean intraoperative remifentanil infusion rate was calculated as the total amount of remifentanil administered during anesthesia divided by body weight and infusion duration, and was expressed as μg/kg/min.
Postoperative adverse events were assessed by the blinded outcome assessors from PACU admission to 72 h postoperatively using direct clinical observation, patient interview, and review of medical and nursing records. Respiratory depression was defined as a respiratory rate <12 breaths/min, and hypoxemia was defined as SpO2 <90%. Local anesthetic systemic toxicity was identified according to compatible neurological or cardiovascular signs.
Sample Size Calculation
The sample size was calculated based on the primary outcome. It has been reported that the minimum clinically important difference in QoR-15 score is 6 points.14 Therefore, we used a between-group difference of 6 points to estimate the required sample size. Based on the preliminary data, the estimated standard deviation (SD) of the QoR-15 score was approximately 12 in both groups. Assuming a two-sided α of 0.05, and a β of 0.1 (90% power), a minimum of 24 participants per group was required. Accounting for an anticipated dropout rate of 5%, the total sample size was 50 participants, with 25 patients allocated to each group.
Statistical Analysis
Statistical analyses of data were performed using SPSS Statistics (version 25.0; IBM Corp., Armonk, NY, USA) and completed by specialized statisticians who were from the Clinical Research Institute of Beijing Friendship Hospital and blinded to grouping assignments. Continuous variables were assessed for normality using the Shapiro–Wilk test and are presented as mean±standard deviation or median (interquartile range), as appropriate. Between-group comparisons of continuous variables were performed using the independent-samples t test for normally distributed data and the Mann–Whitney U-test for non-normally distributed data. Categorical variables were compared using the χ2-test or Fisher’s exact test, as appropriate.
The primary outcome, QoR-15 score, was analyzed as a continuous variable, and the between-group differences were evaluated using ANCOVA, with the group as a fixed factor and the surgical duration as a prespecified covariate. Surgical duration was selected because it reflects procedural complexity and perioperative burden and is associated with postoperative recovery after minimally invasive colorectal surgery.15,16 Adjusted effects are reported as estimated marginal means and adjusted mean differences with 95% confidence intervals. All tests were two-sided, and a p-value of less than 0.05 was considered statistically significant.
The primary analysis was performed in the per-protocol population, defined as the participants who received the allocated intervention, completed laparoscopic surgery without conversion to open surgery or unplanned ICU admission, and had available 24-h QoR-15 data. The modified intention-to-treat population was defined as all randomized participants with available primary outcome data. Following randomization, five participants in the ESPB group were excluded from the per-protocol analysis and had no available 24-h QoR-15 data: two withdrew consent before receiving the ESPB, two underwent conversion to open surgery, and one was unexpectedly admitted to ICU. Because all five participants excluded after randomization had no available 24-h QoR-15 data, the modified intention-to-treat and per-protocol populations were identical and included 55 participants. A complete observed-data intention-to-treat analysis could not be performed because the primary outcome was unavailable for these five participants.
Results
Inclusion and Exclusion of Participants
This study was conducted between July 5 and December 30, 2023. During the study period, 79 participants were screened for eligibility to participate. Of these, 16 did not meet the inclusion criteria, and three declined to participate. Sixty participants were enrolled and randomized. Following randomization, five participants in the ESPB group had no available 24-h QoR-15 data: two withdrew consent before receiving ESPB, two underwent conversion to open surgery, and one required unplanned ICU admission. Ultimately, data from 55 participants were included in the final analysis, with 25 in the ESPB group and 30 in the control group. The CONSORT flow diagram detailing participant enrollment, randomization, and data analysis is shown in Figure 2.
Figure 2.
The CONSORT flow diagram detailing participant enrollment, randomization, and analysis.
Demographic Characteristics and Clinical Data
As shown in Table 1, there were no statistically significant differences between the groups in terms of the demographic characteristics and clinical data.
Table 1.
Demographic and Perioperative Clinical Characteristics
| ESPB Group (n=25) |
Control Group (n=30) |
p value | |
|---|---|---|---|
| Age (years) | 57.0 ± 9.1 | 59.6 ± 7.0 | 0.236 |
| Sex (Male/Female) | 14 (56.0)/11(44.0) | 17(56.7)/13(43.3) | 0.960 |
| Height (cm) | 166.2 ± 8.2 | 166.6 ± 7.5 | 0.851 |
| Weight (kg) | 67.6 ± 11.4 | 64.4 ± 12.9 | 0.334 |
| BMI (kg/m2) | 24.3 ± 2.8 | 23.1 ± 3.6 | 0.148 |
| ASA classification (I/II) | 7 (28.0)/18 (72.0) | 7 (23.3)/23 (76.7) | 0.692 |
| Comorbidities | |||
| Hypertension | 17 (68.0) | 19 (63.3) | 0.781 |
| Diabetes | 7 (28.0) | 7 (23.3) | 0.762 |
| Coronary heart disease | 8 (32.0) | 14 (46.7) | 0.407 |
| Chronic bronchitis | 0 (0) | 1 (3.3) | 1.000 |
| Laboratory tests | |||
| Hemoglobin (g/L) | 123.9 ± 20.2 | 127.2 ± 23.1 | 0.580 |
| Platelets (109/L) | 229.1 ± 61.7 | 224.7 ± 57.7 | 0.785 |
| Albumin (g/L) | 38.2 ± 3.1 | 38.4 ± 4.9 | 0.873 |
| ALT (U/L) | 18.6 ± 15.7 | 17.1 ± 14.0 | 0.724 |
| AST (U/L) | 21.6 ± 16.2 | 19.3 ± 6.7 | 0.490 |
| Creatinine (μmol/L) | 66.4 ± 12.1 | 71.5 ± 16.5 | 0.200 |
| Prothrombin time (s) | 11.4 ± 0.7 | 11.5 ± 0.8 | 0.783 |
| APTT (s) | 27.2 ± 2.4 | 27.6 ± 3.6 | 0.614 |
| Fibrinogen (g/L) | 3.6 ± 0.9 | 3.2 ± 0.7 | 0.121 |
| Type of surgery | 0.073 | ||
| Descending colectomy | 9 (36.0) | 4 (13.3) | |
| Transverse colectomy | 11 (44.0) | 13 (43.3) | |
| Sigmoid colectomy | 5 (20.0) | 13 (43.3) | |
| Anesthesia time (min) | 206.8 ± 53.6 | 199.6 ± 46.4 | 0.595 |
| Surgical duration (min) | 174.1 ± 51.5 | 166.4 ± 47.9 | 0.568 |
Notes: Data are presented as the mean ± standard deviation or number of cases (%). The distribution of surgery types was compared using the Pearson χ2-test.
Abbreviations: ESPB, erector spinae plane block; ASA, American Society of Anesthesiologists; BMI, body mass index; ALT, alanine aminotransferase; AST, aspartate aminotransferase; APTT, activated partial thromboplastin time.
Primary Outcome
After adjustment for surgical duration using the ANCOVA, the QoR-15 score at 24 h postoperatively was significantly higher in the ESPB group than in the control group, with an adjusted mean difference of 5.88 points (95% CI, 4.02–7.74; p<0.001). Exploratory analysis of the subdomains of QoR-15 score using the same ANCOVA model showed that the ESPB group had significantly higher scores in the pain and physical comfort domains (Table 2 and Figure 3).
Table 2.
Adjusted QoR-15 Scores at 24 h Postoperatively
| ESPB Group (n=25) |
Control Group (n=30) |
Adjusted Mean Difference |
95% Confidence Interval |
p value | |
|---|---|---|---|---|---|
| Total score | 126.19 (0.68) | 120.31 (0.62) | 5.88 | (4.02–7.74) | <0.001 |
| Pain | 17.88 (0.25) | 16.97 (0.22) | 0.91 | (0.24–1.59) | 0.009 |
| Physical comfort | 42.25 (0.54) | 37.76 (0.49) | 4.48 | (3.01–5.96) | <0.001 |
| Physical independence | 10.90 (0.37) | 10.55 (0.34) | 0.35 | (−0.68–1.37) | 0.500 |
| Psychological support | 19.88 (0.09) | 19.84 (0.08) | 0.04 | (−0.21–0.30) | 0.742 |
| Emotional state | 35.22 (0.36) | 35.25 (0.32) | −0.03 | (−1.01–0.95) | 0.955 |
Notes: Values are estimated marginal means (standard error, SE) derived from ANCOVA adjusted for surgical duration. All between-group comparisons were performed using the same ANCOVA framework. Subdomain analyses were exploratory.
Figure 3.
The between-group comparisons for five-domain scores of QoR-15 and total QoR-15 scores at 24 h postoperatively. **p<0.01.
Abbreviation: QoR-15, Quality of Recovery-15 questionnaire.
Intraoperative and Postoperative Data
Compared with the control group, the ESPB group required a significantly lower mean intraoperative remifentanil infusion rate and achieved earlier postoperative ambulation. However, no significant differences were observed between the groups with respect to PCIA sufentanil consumption, time to first PCIA demand, time to first flatus, VAS pain score at 24 h postoperatively, or patient satisfaction at 72 h postoperatively (Table 3).
Table 3.
Intraoperative and Postoperative Data
| ESPB Group (n=25) |
Control Group (n=30) |
p value | |
|---|---|---|---|
| Mean intraoperative remifentanil infusion rate (μg/kg/min) | 0.160 ± 0.009 | 0.176 ± 0.014 | <0.001 |
| PCIA sufentanil consumption (μg) | 45.7 ±15.5 | 49.4 ±17.1 | 0.570 |
| VAS score at 24 h postoperatively | 3 (3–6) | 3.5 (2.5–5) | 0.283 |
| Time to first ambulation (h) | 13.6 ± 3.7 | 16.5 ± 3.8 | 0.007 |
| Time to first PCIA demand (min) | 137 ± 52 | 162 ± 78 | 0.177 |
| Time to first flatus (h) | 21 (16–26) | 21 (14–29) | 0.823 |
| Patient satisfaction at 72 h postoperatively | 10 (9–10) | 10 (9–10) | 0.830 |
Notes: Data are presented as mean ± standard deviation or median (interquartile range).
Abbreviations: VAS, Visual Analog Scale; PCIA, patient-controlled intravenous analgesia.
Postoperative Adverse Events
As shown in Table 4, there were no significant differences in the incidence of PONV or low back pain between the groups. No cases of pruritus, respiratory depression, hypoxemia, or local anesthetic toxicity were reported in either group during the observation period.
Table 4.
Postoperative Adverse Events Within 72 h
| ESPB Group (n=25) |
Control Group (n=30) |
p value | |
|---|---|---|---|
| Postoperative nausea and vomiting | 1 | 2 | 1.000 |
| Pruritus | 0 | 0 | NA |
| Low back pain | 1 | 0 | 0.455 |
| Respiratory depression | 0 | 0 | NA |
| Hypoxemia | 0 | 0 | NA |
| Local anesthetic toxicity | 0 | 0 | NA |
Notes: Data are presented as number of participants.
Abbreviation: NA, not applicable.
Discussion
The principal finding of this prospective randomized controlled trial was that adding single-shot bilateral ESPB to a standardized multimodal analgesic regimen was associated with an improved quality of early postoperative recovery after laparoscopic colon cancer surgery. After adjustment for surgical duration, the ESPB group had a higher QoR-15 score at 24 h postoperatively, with significant improvements mainly observed in the pain and physical comfort domains. In addition, ESPB was associated with reduced intraoperative remifentanil use and earlier ambulation, without an obvious increase in postoperative adverse events.
The potential benefit of ESPB may be explained by analgesia with the spread of local anesthetic within the fascial plane deep to the erector spinae muscle. Previous anatomical and imaging studies suggest that local anesthetic injected into this plane may spread cranially and caudally over several vertebral levels and may reach the dorsal and ventral rami of spinal nerves, thereby attenuating somatic and, to some extent, visceral nociceptive input.17–19 In the present study, the bilateral ESPB was performed at the T12 level with the intention of providing analgesic coverage for the abdominal wall and visceral traction areas involved in laparoscopic colon surgery, which are mainly innervated by thoracolumbar segments.20 However, because the sensory extent of ESPB was not formally assessed, the exact dermatomal distribution achieved in individual patients cannot be confirmed. Therefore, the segmental rationale for ESPB performed at the T12 level should be interpreted as an anatomical and clinical consideration rather than direct evidence of blockade across specific spinal segments.
The improvement in QoR-15 score may reflect the role of ESPB as an opioid-sparing regional analgesic component within the multimodal analgesic regimen.5,9 By reducing surgery-associated afferent nociceptive input, ESPB may decrease intraoperative opioid requirements, attenuate surgical stress responses, and improve patient comfort and postoperative outcome.21 These effects are consistent with the observed improvements in the pain and physical comfort domains of QoR-15. Because QoR-15 captures multiple aspects of postoperative recovery, including pain, comfort, emotional well-being, and functional status, even modest improvements in early analgesia and comfort may translate into a higher overall recovery score.13,14
Our findings are generally consistent with previous studies by Sifaki et al and Shi et al, in which perioperative analgesic or recovery-related outcomes are significantly improved when ESPB is incorporated into perioperative multimodal analgesia.12,22 In contrast, Choi et al23 reported that ESPB did not improve QoR-40 scores at 24 h after laparoscopic colorectal surgery. Several factors may explain these discrepancies. First, postoperative analgesic protocols differed among studies. In the study by Choi et al, postoperative analgesia mainly consisted of opioid-based PCIA with background infusion, whereas in the studies by Sifaki et al, Shi et al, and the present study, ESPB was combined with scheduled non-opioid analgesics and opioid administration on demand, consistent with current ERAS-based multimodal analgesic regimens.4,5,24 Second, differences in block timing, local anesthetic dosing, outcome instruments, and perioperative care pathways may have influenced the measured quality-of-recovery outcomes. Therefore, our findings should be interpreted as supporting the incremental benefit of ESPB when incorporated into a standardized multimodal analgesic regimen, rather than the isolated effect of ESPB alone.
In this study, no significant between-group differences were observed in VAS pain scores or PCIA opioid consumption at 24 h postoperatively, though ESPB improved the pain and physical comfort domains of QoR-15. This apparent discrepancy may reflect the different constructs and sensitivities of these outcome measures. The QoR-15 integrates multiple dimensions of postoperative recovery, including pain, physical comfort, emotional well-being, and functional status,13,14 whereas VAS score and opioid consumption mainly reflect pain intensity at a specific time point and are influenced by rescue analgesia protocols.3 Moreover, the analgesic effect of a single-shot ESPB is expected to be most prominent during the early postoperative period and may not be fully captured by pain assessment at 24 h.25 Standardized multimodal analgesia and PCIA may also attenuate between-group differences in conventional pain-related outcomes.26 Taken together, these findings suggest that meaningful improvement in patient-centered recovery can occur even in the absence of detectable differences in conventional pain-related outcomes.
Regarding secondary outcomes, the ESPB group showed a lower mean intraoperative remifentanil infusion rate and a shorter time to first ambulation compared with the control group. The reduction in intraoperative remifentanil requirement suggests that the ESPB performed before surgical incision may have improved intraoperative antinociception and reduced the need for supplemental opioids. Earlier ambulation may be related to improved early comfort, reduced opioid exposure, and avoidance of motor block, which are all consistent with the ERAS principles for colorectal surgery.9 However, no significant between-group differences were observed in time to first PCIA demand, PCIA sufentanil consumption, time to first flatus, or patient satisfaction at 72 h postoperatively. These findings may be partly attributable to the limited duration of a single-shot ESPB and the use of standardized postoperative multimodal analgesia in both groups. The catheter-based continuous ESPB has been recommended as a strategy to extend the duration of analgesia;25 however, its role in laparoscopic colon surgery requires further evaluation.
Postoperative adverse events were recorded using predefined clinical criteria, including PONV, pruritus, low back pain, respiratory depression, hypoxemia, and signs of local anesthetic systemic toxicity. No cases of respiratory depression, hypoxemia, pruritus, or local anesthetic toxicity were observed. The few events recorded, including PONV and low back pain, were infrequent and did not differ significantly between groups. Given the standardized use of general anesthetics, opioids, PCIA, NSAIDs and local wound infiltration in both groups, these events cannot be attributed specifically to ESPB. The absence of local anesthetic toxicity and the comparable incidence of adverse events suggest that adding a single-shot bilateral ESPB did not introduce an obvious additional safety signal in this cohort.
Surgery type and surgical duration were not significantly different between groups, but this study included different types of laparoscopic colon resections, which may have different procedural complexity and recovery profiles. Surgical duration was therefore used as a prespecified covariate because it reflects procedural complexity and perioperative burden and is associated with postoperative recovery after minimally invasive colorectal surgery.15,16 Adjustment for surgical duration was intended to improve the power of primary outcome analysis and attenuate the potential influence of procedural variability.2,27,28 The adjusted between-group difference of 5.88 points for QoR-15 score was close to, but slightly below, the reported MCID of 6 points, and its confidence interval crossed this threshold.14 Therefore, the magnitude of clinical benefit with additional ESPB should be interpreted cautiously.
Several measures were used to minimize potential biases, including concealed random allocation, use of a sham procedure in the control group, separation of anesthesiologist performing the studied interventions from intraoperative management and postoperative outcome assessment, blinded postoperative QoR-15 assessment, standardized perioperative analgesic protocols, and adjustment for surgical duration in the primary outcome analysis. Nevertheless, the possibility of residual bias cannot be completely excluded.
Limitations
This study has several limitations. First, this was a single-center trial with a small sample size, and all ESPB procedures were performed by an experienced anesthesiologist. Thus, the generalizability of our findings requires further validation in larger multicenter randomized controlled trials. Second, although a sham procedure involving lateral positioning, skin disinfection, and ultrasound probe placement was used in the control group, complete procedural blinding was not feasible because skin puncture and local anesthetic injection were not performed in controls. Therefore, performance bias cannot be fully excluded despite of blinded postoperative outcome assessment. Third, a fixed volume of 20 mL of ropivacaine was administered for ESPB on each side, and the extent of local-anesthetic spread may have varied among patients, potentially resulting in suboptimal blockade in some cases. Fourth, due to the slow onset of ESPB and the need for efficient operating room turnover, we did not assess the exact sensory distribution and onset time of ESPB before induction of general anesthesia. Fifth, five participants were excluded after randomization, all from the ESPB group, and a complete intention-to-treat analysis could not be performed because the primary outcome was unavailable. Therefore, attrition bias cannot be completely excluded. Finally, all enrolled patients were ASA physical status classification I–II and received a multimodal analgesic regimen based on our institutional protocol; therefore, the results may not be directly applicable to high-risk surgical populations or centers using different perioperative analgesia protocols.
Conclusions
In this single-center randomized controlled trial, adding single-shot bilateral ESPB to a multimodal analgesic regimen was associated with an improved quality of early postoperative recovery, a reduced intraoperative opioid requirement, and earlier ambulation after laparoscopic colon cancer surgery, without an obvious increase in adverse events. These findings suggest that the ESPB may be considered as a component of multimodal analgesia in this setting, though confirmation in larger multicenter trials is warranted.
Acknowledgments
We thank the colorectal surgery team at Beijing Friendship Hospital, Capital Medical University, and all participants for their support and cooperation throughout this study.
Funding Statement
This study received no funding.
Trial Registration
This study was prospectively registered in the Chinese Clinical Trial Registry on July 4, 2023 (Chictr.org.cn; Identifier: ChiCTR2300073180). The registered protocol corresponds to the present study, and no interim analysis from the same dataset has been previously published.
Abbreviations
ASA, American Society of Anesthesiologists; BIS, bispectral index; CI, confidence interval; ERAS, Enhanced Recovery After Surgery; ESPB, erector spinae plane block; HR, heart rate; NSAID, nonsteroidal anti-inflammatory drug; PCIA, patient-controlled intravenous analgesia; PETCO2, end-tidal carbon dioxide partial pressure; PONV, postoperative nausea and vomiting; QoR-15, Quality of Recovery-15 questionnaire; SpO2, pulse oxygen saturation; VAS, visual analog scale.
Data Sharing Statement
The datasets generated and analyzed during the current study are available from the corresponding author upon reasonable request.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
The authors declare no conflicts of interest in this work.
References
- 1.Xia C, Dong X, Li H. et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J. 2022;135(5):584–12. doi: 10.1097/CM9.0000000000002108 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Ekstein P, Szold A, Sagie B, Werbin N, Klausner JM, Weinbroum AA. Laparoscopic surgery may be associated with severe pain and high analgesia requirements in the immediate postoperative period. Ann Surg. 2006;243(1):41–46. doi: 10.1097/01.sla.0000193806.81428.6f [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Pirie K, Traer E, Finniss D, Myles PS, Riedel B. Current approaches to acute postoperative pain management after major abdominal surgery: a narrative review and future directions. Br J Anaesth. 2022;129(3):378–393. doi: 10.1016/j.bja.2022.05.029 [DOI] [PubMed] [Google Scholar]
- 4.Cavallaro P, Bordeianou L. Implementation of an ERAS pathway in colorectal surgery. Clin Colon Rectal Surg. 2019;32(2):102–108. doi: 10.1055/s-0038-1676474 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5.Joshi GP. Regional analgesia as the core component of multimodal analgesia technique: current controversies and future directions. J Clin Anesth. 2024;92:111227. doi: 10.1016/j.jclinane.2023.111227 [DOI] [PubMed] [Google Scholar]
- 6.Macías AA, Finneran JJ. Regional anesthesia techniques for pain management for laparoscopic surgery: a review of the current literature. Curr Pain Headache Rep. 2022;26(1):33–42. doi: 10.1007/s11916-022-01000-6 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7.Mancel L, Van Loon K, Lopez AM. Role of regional anesthesia in enhanced recovery after surgery (ERAS) protocols. Curr Opin Anaesthesiol. 2021;34(5):616–625. doi: 10.1097/aco.0000000000001048 [DOI] [PubMed] [Google Scholar]
- 8.Daghmouri MA, Akremi S, Chaouch MA, et al. Bilateral erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a systematic review and meta-analysis of randomized controlled trials. Pain Pract. 2021;21(3):357–365. doi: 10.1111/papr.12953 [DOI] [PubMed] [Google Scholar]
- 9.Sia CJ-Y, Wee S, Au-Yong AP-S, et al. Analgesia efficacy of erector spinae plane block in laparoscopic abdominal surgeries: a systemic review and meta-analysis. Int J Surg. 2024;110(7):4393–4401. doi: 10.1097/js9.0000000000001421 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10.Yang X, Zhang Y, Chen Y, Xu M, Lei X, Fu Q. Analgesic effect of erector spinae plane block in adults undergoing laparoscopic cholecystectomy: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2023;23(1):7. doi: 10.1186/s12871-023-01969-6 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Choi YJ, Kwon HJ, J O, et al. Influence of injectate volume on paravertebral spread in erector spinae plane block: an endoscopic and anatomical evaluation. PLoS One. 2019;14(10):e0224487. doi: 10.1371/journal.pone.0224487 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 12.Sifaki F, Vogiatzaki T, Mantzoros I, et al. The effectiveness of ultrasound-guided, continuous, bilateral erector spinae plane block in perioperative pain management of patients undergoing colorectal surgery: a randomized, controlled, double blind, prospective trial. J Clin Med. 2023;12(23):7465. doi: 10.3390/jcm12237465 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 13.Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score. Anesthesiology. 2013;118:1332–1340. doi: 10.1097/ALN.0b013e318289b84b [DOI] [PubMed] [Google Scholar]
- 14.Myles PS, Myles DB. An updated minimal clinically important difference for the QoR-15 scale. Anesthesiology. 2021;135:925–935. doi: 10.1097/ALN.0000000000003977 [DOI] [PubMed] [Google Scholar]
- 15.Li H, Luo T-F, Zhang N-R, Zhang L-Z, Huang X, Jin S-Q. Factors associated with prolonged postoperative length of hospital stay after laparoscopic colorectal cancer resection: a secondary analysis of a randomized controlled trial. BMC Surg. 2022;22(1):438. doi: 10.1186/s12893-022-01886-4 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16.Unruh KR, Bastawrous AL, Kanneganti S, et al. The impact of prolonged operative time associated with minimally invasive colorectal surgery: a report from the surgical care outcomes assessment program. Dis Colon Rectum. 2024;67(2):302–312. doi: 10.1097/dcr.0000000000002925 [DOI] [PubMed] [Google Scholar]
- 17.Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The erector spinae plane block: a novel analgesic technique in thoracic neuropathic pain. Reg Anesth Pain Med. 2016;41(5):621–627. doi: 10.1097/AAP.0000000000000451 [DOI] [PubMed] [Google Scholar]
- 18.Ivanusic J, Konishi Y, Barrington MJ. A cadaveric study investigating the mechanism of action of erector spinae blockade. Reg Anesth Pain Med. 2018;43(6):567–571. doi: 10.1097/AAP.0000000000000789 [DOI] [PubMed] [Google Scholar]
- 19.Keles BO, Salman N, Yilmaz ET, et al. Comparison of the median and intermediate approaches to the ultrasound-guided sacral erector spinae plane block: a cadaveric and radiologic study. Korean J Anesthesiol. 2024;77(1):156–163. doi: 10.4097/kja.23604 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anatomy. 2012;221(6):507–536. doi: 10.1111/j.1469-7580.2012.01511.x [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Cui Y, Wang Y, Yang J, et al. The effect of single-shot erector spinae plane block (ESPB) on opioid consumption for various surgeries: a meta-analysis of randomized controlled trials. J Pain Res. 2022;15:683–699. doi: 10.2147/JPR.S346809 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 22.Shi S, Liang Y, Liu T, et al. Effects of ropivacaine-based thoracic paravertebral block versus erector spinae plane block on quality of recovery in laparoscopic colorectal cancer surgery: a randomized controlled trial. Drug Des Devel Ther. 2026;20:581084. doi: 10.2147/dddt.S581084 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Choi JJ, Chang YJ, Lee D, Kim HW, Kwak HJ. Effect of erector spinae plane block on postoperative pain after laparoscopic colorectal surgery: a randomized controlled Study. J Pers Med. 2022;12(10):1717. doi: 10.3390/jpm12101717 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 24.Simpson JC, Bao X, Agarwala A. Pain management in enhanced recovery after surgery (ERAS) protocols. Clin Colon Rectal Surg. 2019;32(2):121–128. doi: 10.1055/s-0038-1676477 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 25.Taketa Y, Takayanagi Y, Irisawa Y. Programmed intermittent bolus infusion vs continuous infusion for erector spinae plane block in video-assisted thoracoscopic surgery: a double-blinded randomised controlled trial. Eur J Anaesthesiol. 2023;40(2):130–137. doi: 10.1097/EJA.0000000000001788 [DOI] [PubMed] [Google Scholar]
- 26.Maia L, Chaves I, Medeiros H, Silva GF, da Silva WA. Impact of opioids on hospital stay and mortality in patients undergoing abdominal surgeries. Anesthesiol Perioper Sci. 2024;2(4):33. doi: 10.1007/s44254-024-00071-5 [DOI] [Google Scholar]
- 27.Umano GR, Delehaye G, Noviello C, Papparella A. The “dark side” of pneumoperitoneum and laparoscopy. Minim Invasive Surg. 2021;2021:5564745. doi: 10.1155/2021/5564745 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 28.Keller DS, Tantchou I, Flores-Gonzalez JR, Geisler DP. Predicting delayed discharge in a multimodal enhanced recovery pathway. Am J Surg. 2017;214(4):604–609. doi: 10.1016/j.amjsurg.2017.06.008 [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets generated and analyzed during the current study are available from the corresponding author upon reasonable request.