Abstract
Background
Older adults undergoing laparoscopic transabdominal preperitoneal (TAPP) hernia repair often experience inadequate analgesia and delayed mobilization. We tested the hypothesis that dual-plane abdominal wall blocks (transversus abdominis plane + rectus sheath block, TAP+RSB) using liposomal bupivacaine (LB) improve opioid-sparing and recovery versus standard bupivacaine (BP) or no block.
Methods
In this single-center, randomized, three-arm trial, 147 patients aged ≥70 years were assigned 1:1:1 to LB‑TAP+RSB (LB group, n=49), BP‑TAP+RSB (BP group, n=49), or no block (control, n=49). Anaesthesia was standardised to maintain BIS 40–60. The primary outcome was 48‑hour opioid consumption (intravenous morphine equivalents). Secondary outcomes included time to first rescue analgesia, pain scores at rest/on movement, time to ambulation, time to extubation, length of stay, and adverse events.
Results
Total opioid use was significantly lower in both block groups versus control (BP: –5.53 mg, 95% CI –8.08 to –2.99; LB: –7.24 mg, 95% CI –9.80 to –4.69). Fewer LB patients needed early rescue analgesia than controls (2.0% vs 18.4%, OR 0.10, 95% CI 0.01–0.84). At 8 h, rest pain was lower with LB (P=0.007). Ambulation time was shortest with LB (14.1±2.5 h) compared with BP (16.7±6.5 h) and control (20.0±6.2 h) (both P≤0.006). Extubation occurred earlier in block groups (LB/BP median 2 min vs control 6 min, P<0.001). Hospital stay was shorter with blocks (median 3 vs 4 days, P<0.001). Adverse events did not differ between groups.
Conclusion
Dual-plane TAP+RSB, particularly with LB, reduces opioid need and speeds recovery in older TAPP patients, supporting its use in ERAS pathways.
Keywords: liposomal bupivacaine, TAP block, rectus sheath block, TAPP hernia repair, older adults
Plain Language Summary
Question
: In older adults (≥70 y) undergoing laparoscopic TAPP hernia repair, does a dual-plane abdominal wall block (TAP + rectus sheath) with liposomal bupivacaine (LB) reduce 48-h opioid use and improve early recovery versus standard bupivacaine or no block?
Findings
: In a single-center, three-arm randomized trial (n=147), total 48-h opioid consumption was lower vs control with standard bupivacaine (–5.53 mg IV morphine equivalents) and with LB (–7.24 mg); early rescue analgesia was less frequent with LB (1/49 vs 9/49), rest pain at 8 h was lower, ambulation and extubation occurred earlier, length of stay was shorter, and adverse events were similar across groups.
Meaning
: Dual-plane TAP + RSB—particularly with LB—achieves clinically meaningful opioid-sparing and accelerates early recovery without compromising safety, supporting integration into ERAS pathways for elderly TAPP hernia repair.
Introduction
Laparoscopic inguinal hernia repair, particularly the transabdominal preperitoneal (TAPP) approach, is widely used owing to its reduced postoperative pain and faster recovery compared with open techniques.1,2 With the ageing global population, elderly patients constitute a growing proportion of individuals undergoing hernia surgery. However, effective pain management in this population remains challenging. Poorly controlled postoperative pain may delay mobilization, prolong hospital stay, and increase the risk of complications.3–6 Furthermore, elderly patients are more vulnerable to opioid-related adverse events, including nausea, sedation, respiratory depression, and postoperative delirium.7 These concerns have led to increased interest in multimodal and opioid-sparing analgesic strategies in this high-risk group.
Ultrasound-guided regional anaesthesia techniques, such as the TAP+RSB, are commonly incorporated into enhanced recovery protocols for abdominal surgery.8 These fascial plane blocks provide somatic analgesia to the anterior abdominal wall and are particularly relevant in minimally invasive groin hernia repair.9,10 However, the duration of analgesia provided by conventional local anaesthetics such as bupivacaine is typically limited to 8–12 hours, often necessitating supplemental systemic opioids during the early postoperative period.11 This limitation is particularly relevant in elderly patients, where prolonged and opioid-free analgesia is desirable.
LB is a multivesicular formulation designed to provide sustained release of bupivacaine over 72 hours.12 Several studies have evaluated its utility in fascial plane blocks and demonstrated reductions in opioid consumption and improved postoperative comfort in various surgical settings.6,13–15 However, high-quality evidence supporting its use in TAP/RSB blocks for laparoscopic hernia repair remains limited. Furthermore, few randomized trials have investigated its efficacy specifically in elderly patients, who may derive greater benefit from extended analgesia due to altered pharmacokinetics and increased sensitivity to opioids.
This randomized controlled trial aimed to compare the analgesic efficacy and recovery outcomes of LB versus standard bupivacaine or no block when administered via TAP/RSB blocks in elderly patients undergoing laparoscopic inguinal hernia repair. We hypothesized that LB would prolong the time to first analgesic request, reduce postoperative opioid use, and enhance recovery without increasing adverse events in this vulnerable population.
Methods
Study Design and Ethics
This is a prospective, single-center, randomized controlled trial conducted at Zhongshan Hospital, Fudan University (Shanghai, China). The study protocol was approved by the Ethics Committee of Zhongshan Hospital, Fudan University (approval number: B2024-226R), and the trial was registered with the Chinese Clinical Trial Registry (ChiCTR2400086990). The trial was conducted in accordance with the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Written informed consent was obtained from all participants prior to enrolment.
Participants
Patients aged ≥70 yr who were scheduled for elective laparoscopic inguinal hernia repair at Zhongshan Hospital, Fudan University (Shanghai, China) were considered eligible for inclusion from July 16, 2024 to July 31, 2025. Additional inclusion criteria included ASA physical status I–III, intact preoperative sensory and motor function, and no known allergy to general anesthetic agents or any component of the study drugs. Patients were excluded if they had cognitive impairment, a history of abdominal surgery, chronic opioid use or substance abuse, hepatic or renal dysfunction, known allergy to local anesthetics or opioids, or any contraindication to regional anesthesia. Intraoperative exclusion criteria included allergic reactions to anesthetic agents, conversion to open surgery, or patient withdrawal of consent during the perioperative period. Exclusions due to conversion to open surgery occurred post-randomization and were analyzed on an intention-to-treat basis where applicable.
Randomization and Blinding
Participants were randomly assigned in a 1:1:1 ratio to one of three groups: LB group, standard bupivacaine group, or control (no block) group. Randomization was performed using a computer-generated random sequence in blocks of four or six. Group allocation was concealed in sequentially numbered, opaque, sealed envelopes prepared by an independent research assistant not involved in patient care or outcome assessment.
This was a randomized, triple-blind (patient, surgeon, outcome assessor), controlled trial. The anesthesiologist could not be blinded. Allocation concealment was maintained by using identical syringes hidden from the patient and surgeon. All postoperative data collection was performed by a blinded research assistant to minimize assessment bias.
Anesthesia and Intervention Protocols
All patients were appropriately fasted. Bispectral index (BIS) along with ASA standard monitoring was used. The patient was placed in the supine position and preoxygenated for 5 minutes. Anesthesia was induced with intravenous propofol (Target-controlled infusion, TCI, 3 μg/mL), remifentanil (TCI, 3 ng/mL), and rocuronium (0.8 mg/kg) to facilitate tracheal intubation and maintained with sevoflurane (1.5–2.5%) in 50% oxygen/air. Additional sufentanil boluses (0.05–0.1 μg/kg) were administered as needed. BIS was maintained between 40 and 60.
For patients in the intervention groups, the TAP+RSB were performed after anesthesia induction and before surgical incision using a high-frequency linear ultrasound probe (6–13 MHz, SonoSite®). All blocks were performed by an experienced anesthesiologist under strict aseptic conditions.
In the LB group, 20 mL of LB (266mg) was diluted with 20 mL of normal saline to a total volume of 40 mL and injected as 20 mL per side (10 mL for TAP and 10 mL for RSB).
In the BP group, 40 mL of 0.25% plain bupivacaine was injected in the same distribution.
The control group received an equivalent volume intravenous injection of normal saline.
All patients received intravenous ondansetron (4 mg) before the end of surgery. Postoperative analgesia included intravenous parecoxib (40 mg q12h) and rescue morphine (2–5 mg IV) as needed, titrated to maintain a VAS pain score <4. The same surgical team performed all laparoscopic transabdominal preperitoneal (TAPP) repairs using standardized techniques.
Outcomes
The primary outcome was total perioperative opioid consumption, expressed as intravenous morphine equivalents (mg), including all intraoperative and postoperative opioid use until 48 hours after surgery. Morphine 10 mg IV = Morphine 10 mg IM = Morphine 30 mg PO = remifentanil 10 μg IV = Fentanyl 0.1 mg IV = Sufentanil 10 μg IV = Hydromorphone 1.5 mg IV = Oxycodone 10 mg IV = Oxycodone 20 mg PO = Butorphanol 2 mg IV = Tramadol 100 mg IV = Pethidine 100 mg IV = Dezocine 10 mg IV.
Secondary outcomes included: a) to tracheal extubation after surgery, postoperative sedation and recovery status assessed using the Steward score and Ramsay Sedation Scale, b) number of postoperative rescue analgesic administrations within 48 hours, c) pain intensity scores at rest and during movement at 8 and 24 hours postoperatively, assessed using an 11-point numerical rating scale (NRS, 0 = no pain, 10 = worst imaginable pain), d) incidence of analgesia-related adverse events including pruritus, nausea and vomiting, and dizziness, e) presence of sensory or motor abnormalities or other discomfort in the nerve block distribution area, f) patient satisfaction with postoperative analgesia, assessed using a 1-point Likert scale (0 = dissatisfied; 1 = satisfied), g) time to first ambulation after surgery, h) length of postoperative hospital stay, i) quality of postoperative recovery at 24 hours and 48 hours, assessed using the validated Chinese version of the QoR-15 questionnaire, k) Sleep quality assessed at preoperatively and 24 hours via Numeric Rating Scale 0–10, l) cognitive function assessed using MMSE at preoperatively and 24 hours. All outcomes were assessed by trained personnel who were blinded to group allocation.
Sample Size and Statistical Analysis
The sample size was calculated based on the primary outcome of total perioperative opioid consumption, expressed as intravenous morphine equivalents. According to previous literature and data from a preliminary pilot study, the mean morphine-equivalent consumption was estimated at 30 mg in the general anesthesia (GA) group and 20 mg in both the LB and BP groups. Using PASS version 15.0 (NCSS, LLC, Kaysville, UT, USA), we calculated that a total of 141 participants (47 per group) would be required to detect this difference, assuming a two-sided α of 0.025 and a power of 80%. To account for an anticipated dropout rate of 5%, we aimed to enroll at least 147 patients in total (49 per group).
All statistical analyses were performed using SPSS version 26.0 (IBM Corp., Armonk, NY, USA). Continuous variables were first assessed for normality using the Shapiro–Wilk test. Data are presented as mean (standard deviation) for normally distributed variables or median [interquartile range] for non-normally distributed variables. Categorical variables are presented as numbers (percentages).
Between-group comparisons of continuous variables were performed using one-way ANOVA for normally distributed data or the Kruskal–Wallis test for skewed data. Post-hoc comparisons were adjusted using the Bonferroni correction. Categorical variables were compared using the χ2-test or Fisher’s exact test, as appropriate. For repeated measurements such as postoperative pain scores and sedation levels, linear mixed-effects models were used with fixed effects for time, group, and time–group interaction. Pairwise contrasts were used to explore significant interaction effects.
Sensitivity analyses based on summary statistics showed that the reduction in 48-hour morphine-equivalent opioid use was robust to alternative distributional assumptions and uncertainty in variance. Parametric bootstrap under a normal data-generating process (and, separately, a log-normal process to allow right skew) yielded mean-difference estimates and 95% Cis that were consistent with the primary Welch analysis. Stress tests that inflated/deflated group SDs by ±20% and contamination models introducing a 5% heavy-tail component in either the control or active arms.
Time-to-event outcomes (eg, time to first ambulation) were analyzed using Kaplan–Meier survival analysis and compared using the Log rank test. A two-sided P value <0.05 was considered statistically significant, except for primary outcome comparisons across three groups, for which a Bonferroni-adjusted α = 0.025 was applied.
Results
A total of 147 older patients undergoing elective laparoscopic inguinal hernia repair were randomised to receive plain bupivacaine (BP group), normal saline (control group), or LB group (Figure 1). Baseline demographic and clinical variables were well balanced across the three groups. The median age was similar between groups (BP 75.0 yr; control 76.0 yr; LB 74.0 yr), and most patients were male. The body mass index (BMI) was slightly lower in the control group compared with the BP and LB groups. ASA physical status was predominantly class II in all groups. The prevalence of major comorbidities did not differ significantly. Other characteristics, including hernia laterality, duration of disease, and history of prior surgery, were similarly distributed (Table 1).
Figure 1.
Study flow.
Table 1.
Patient Demographics and Baseline Characteristics
| Characteristic | Group | ||
|---|---|---|---|
| LB Group, N = 49 | BP Group, N = 49 | Control Group, N = 49 | |
| Age, yr | 74.0 (71.0, 76.0) | 75.0 (73.0, 77.0) | 76.0 (75.0, 79.0) |
| BMI, Kg m−2 | 23.88 (21.74, 25.59) | 23.44 (22.45, 24.78) | 21.26 (20.20, 24.08) |
| Male sex, n (%) | 47 (95.9%) | 46 (93.9%) | 48 (98.0%) |
| ASA, classification, n (%) | |||
| 1 | 15 (30.6%) | 14 (28.6%) | 14 (28.6%) |
| 2 | 27 (55.1%) | 27 (55.1%) | 28 (57.1%) |
| 3 | 7 (14.3%) | 8 (16.3%) | 7 (14.3%) |
| Hypertension | 23 (46.9%) | 25 (51.0%) | 26 (53.1%) |
| Diabetes | 3 (6.1%) | 4 (8.2%) | 5 (10.2%) |
| Coronary Disease | 5 (10.2%) | 7 (14.3%) | 4 (8.2%) |
| Others | 5 (10.2%) | 8 (16.3%) | 6 (12.2%) |
Note: The data are given as Median (IQR), or n (%).
Abbreviations: ASA, American Society of Anesthesiologists; BMI, body mass index; LB, liposomal bupivacaine; BP, bupivacaine.
Total perioperative opioid consumption within 48 hours was reduced in both active groups versus control. Mean (SD) morphine-equivalent use was 24 (7) mg in controls, 18 (7) mg with plain bupivacaine (BP), and 17 (6) mg with LB. Compared with control, the estimated mean differences were –5.53 mg (95% CI –8.08 to –2.99) for BP and –7.24 mg (95% CI –9.80 to –4.69) for LB, corresponding to relative reductions of 25.00% and 29.17%, respectively. Standardized effects derived from the reported means/SDs and sample sizes were Hedges’ g –0.85 (BP) and –1.06 (LB), indicating moderate-to-large effects; negative values favor the active group. Stress tests that inflated/deflated group SDs by ±20% and contamination models introducing a 5% heavy-tail component in either the control or active arms left the direction and statistical significance unchanged (BP vs control: Pr[Δ<0]≈0.99–1.00; LB vs control: Pr[Δ<0]≈1.00). These findings indicate that the observed opioid-sparing effect is not driven by modeling choices or outliers (Tables 2, 3 and Figure 2).
Table 2.
Baseline Characteristics and Group Comparisons of Postoperative Analgesia and Functional Recovery Outcomes
| Characteristic | Group | P-value | ||
|---|---|---|---|---|
| LB Group, N = 49 | BP Group, N = 49 | Control Group, N = 49 | ||
| Total Morphine Equivalents Consumption | 17 ± 6 | 18 ± 7 | 24 ± 7 | <0.001 |
| NRS Score at Rest (8h Post-PACU) | 1.08 ± 0.27 | 1.24 ± 0.51 | 1.54 ± 0.64 | <0.001 |
| NRS Score on Movement (8h Post-PACU) | 1.36 ± 0.66 | 1.65 ± 0.87 | 1.80 ± 0.88 | 0.023 |
| NRS Score at Rest (24h Post-PACU) | 1.56 ± 1.01 | 1.61 ± 0.96 | 1.85 ± 1.09 | 0.295 |
| NRS Score on Movement (24h Post-PACU) | 2.44 ± 1.34 | 2.55 ± 1.27 | 2.39 ± 1.42 | 0.826 |
| Sleep Quality from Baseline | −0.8±1.03 | −0.4±1.2 | 0.1±1.5 | <0.001 |
| QoR-15 Score on Postoperative Day 1 | 141 ± 10 | 139 ± 11 | 139 ± 14 | 0.605 |
| QoR-15 Score on Postoperative Day 2 | 145 ± 5 | 144 ± 6 | 143 ± 10 | 0.220 |
| Time to First Ambulation (h) | 14.1 ± 2.5 | 16.7 ± 6.5 | 20.0 ± 6.2 | <0.001 |
| MMSE change from baseline | −2.1±2.27 | −2.6±1.9 | −1.9±2.5 | 0.138 |
Table 3.
Pairwise Comparisons of Postoperative Analgesia and Recovery Outcomes
| Effect Size or OR (95% CI) | P-value | |
|---|---|---|
| Total Morphine Equivalents Consumption | ||
| BP Group vs Control Group | 5.53 (2.99, 8.08) | <0.001 |
| LB Group vs Control Group | −7.24 (−9.80, −4.69) | <0.001 |
| BP Group vs LB Group | −1.71 (−4.30, 0.88) | 0.401 |
| NRS Score at Rest (8h Post-PACU) | ||
| BP Group vs Control Group | 0.30 (0.11, 0.49) | 0.007 |
| LB Group vs Control Group | −0.46 (−0.65, −0.26) | <0.001 |
| BP Group vs LB Group | −0.16 (−0.35, 0.04) | 0.269 |
| NRS Score on Movement (8h Post-PACU) | ||
| BP Group vs Control Group | 0.15 (−0.16, 0.46) | 0.614 |
| LB Group vs Control Group | −0.44 (−0.75, −0.12) | 0.019 |
| BP Group vs LB Group | −0.29 (−0.60, 0.03) | 0.18 |
| Sleep Quality from Baseline | ||
| BP Group vs Control Group | 0.73 (0.35, 1.11) | <0.001 |
| LB Group vs Control Group | −0.97 (−1.35, −0.59) | <0.001 |
| BP Group vs LB Group | −0.24 (−0.63, 0.14) | 0.434 |
| Time to First Ambulation (h) | ||
| BP Group vs Control Group | 3.29 (1.21, 5.38) | 0.006 |
| LB Group vs Control Group | −5.86 (−7.95, −3.77) | <0.001 |
| BP Group vs LB Group | −2.57 (−4.69, −0.44) | 0.05 |
Notes: The data are given as mean ± SD. The opioids conversion method: Morphine 10 mg IV = Morphine 10 mg IM = Morphine 30 mg PO = remifentanil 10 μg IV = Fentanyl 0.1 mg IV = Sufentanil 10 μg IV = Hydromorphone 1.5 mg IV = Oxycodone 10 mg IV = Oxycodone 20 mg PO = Butorphanol 2 mg IV = Tramadol 100 mg IV = Pethidine 100 mg IV = Dezocine 10 mg IV.
Abbreviations: PACU, postanaesthesia care unit; LB, liposomal bupivacaine; BP, bupivacaine.
Figure 2.
Sensitivity analysis of liposomal bupivacaine’s analgesic efficacy.
Time to first rescue analgesia differed significantly across groups. As shown in Figure 3, the cumulative probability of not requiring rescue analgesia was highest in the LB group and lowest in the control group (log-rank P = 0.04). Patients in the LB group exhibited a more prolonged analgesia duration, with fewer early requests for rescue analgesia within the first 15 h postoperatively.
Figure 3.
Kaplan-Meier analysis of time to first analgesic requirement following surgical intervention.
Pain scores at 8 h postoperatively were significantly lower in the LB group compared to the control group at rest (1.08 ± 0.27 vs 1.54 ± 0.64; P < 0.001) and on movement (2.18 ± 0.47 vs 2.80 ± 0.94; P = 0.019). The BP group also showed lower pain scores than control at rest (P = 0.007), but not significantly different on movement (P = 0.614) (Table 2).
Time to first ambulation was shorter in both the LB (14.1 ± 2.5 h) and BP (16.7 ± 6.5 h) groups compared with the control group (20.0 ± 6.2 h), with respective mean differences of –5.86 h (P < 0.001) and –3.34 h (P = 0.006) (Table 3).
Fewer patients required rescue analgesia in the LB group (1/49, 2.0%) than in the control group (9/49, 18.4%; P = 0.011), with an odds ratio of 0.10 (95% CI: 0.01–0.84). The difference between the BP and control groups was not statistically significant (OR: 0.31; P = 0.082).
There were no significant differences among the three groups in terms of intraoperative blood loss, urine output, or fluid volume administered (P > 0.05 for all; Table 4). Median surgical duration was significantly longer in the LB group (44 [34–60] min) than in the control group (34 [25–45] min; P = 0.017), whereas the duration in the plain bupivacaine (BP) group (40 [29–56] min) was intermediate.
Table 4.
Comparative Analysis of Perioperative Characteristics
| Characteristic | Group | p-value | ||
|---|---|---|---|---|
| LB Group, N = 49 | BP Group, N = 49 | Control Group, N = 49 | ||
| Bleeding (mL) | 5.00 (5.00, 5.00) | 5.00 (5.00, 5.00) | 5.00 (5.00, 5.00) | 0.635 |
| Fluid Resuscitation (mL) | 500 (500, 1000) | 500 (500, 1000) | 500 (500, 1000) | 0.138 |
| Operative Time (min) | 44 (34, 60) | 40 (29, 56) | 34 (25, 45) | 0.017 |
| Time to Extubation (min) | 2.00 (1.00, 4.00)* | 2.00 (1.00, 2.50)* | 6.00 (5.00, 8.00) | <0.001 |
| Length of Hospital Stay (LOS) | 3.00 (2.00, 3.00)*,# | 3.00 (3.00, 3.00)* | 4.00 (3.00, 4.00) | <0.001 |
| Postoperative Length of Stay (D) | 1.00 (1.00, 1.00)* | 1.00 (1.00, 1.00)* | 2.00 (1.00, 2.00) | <0.001 |
| Analgesia Satisfaction | 49 (100.0%) | 48 (97.9%) | 45 (91.8%) | 0.068 |
| Major Complications | 0.472 | |||
| Dizziness | 1 (2.0%) | 1 (2.0%) | 2 (4.1%) | |
| Nausea and Vomiting | 1 (2.0%) | 1 (2.0%) | 3 (6.1%) | |
| Poor Healing | 0 (0.0%) | 1 (2.0%) | 0 (0.0%) | |
Notes: *P < 0.05 vs Control group; #P < 0.05 vs BP group (Mann–Whitney U-test).
Abbreviations: LB, liposomal bupivacaine; BP, bupivacaine.
Time from cessation of anesthesia to extubation was markedly shorter in both the LB and BP groups (2.00 [1.00–4.00] min and 2.00 [1.00–2.50] min, respectively) than in the control group (6.00 [5.00–8.00] min; P < 0.001), suggesting improved recovery profiles with regional blocks (Table 4).
Postoperative hospital stay was reduced in the LB (1.00 [1.00–1.00] days) and BP (1.00 [1.00–1.00] days) groups compared to the control group (2.00 [1.00–2.00] days; P < 0.001), with overall hospitalization duration also significantly shorter (LB: 3.00 [2.00–3.00] days; BP: 3.00 [3.00–3.00] days; control: 4.00 [3.00–4.00] days; P < 0.001) (Table 4).
Analgesia satisfaction was high across all groups, with no significant difference (overall P = 0.068). Most patients in the LB group (100.0%) reported a satisfaction score of 1 (highest level), compared to 97.9% in the BP group and 91.8% in the control group (Table 4).
The incidence of postoperative adverse events, including dizziness, nausea/vomiting, and poor wound healing, was low and comparable among groups (P = 0.472), with no serious complications reported (Table 4). Haemodynamics varied over time (MAP fell from baseline around incision and partially recovered by extubation; HR rose towards extubation), with no statistically significant between-group differences and no group-by-time interaction on mixed-effects modelling (Figure 4).
Figure 4.
Comparative analysis of mean arterial pressure (MAP) and heart rate (HR) among control, plain bupivacaine (BP), and liposomal bupivacaine (LB) groups at baseline, skin incision, and extubation. *Control group vs BP group: P<0.05.
To address potential confounding by surgical duration, we adjusted for surgery time in the analysis. The results for opioid consumption, pain scores, and recovery metrics remained consistent after this adjustment, reinforcing the robustness of the observed effects of LB on postoperative analgesia and recovery (Table 5 and Table 6).
Table 5.
Sensitivity Analysis of Postoperative Analgesia and Recovery
| Characteristic | Group | P-value | ||
|---|---|---|---|---|
| LB Group, N = 49 | BP Group, N = 49 | Control Group, N = 49 | ||
| Total Morphine Equivalents Consumption | 17 ± 6 | 18 ± 7 | 24 ± 7 | <0.001 |
| NRS Score at Rest (8h Post-PACU) | 1.08 ± 0.27 | 1.24 ± 0.51 | 1.54 ± 0.64 | <0.001 |
| NRS Score on Movement (8h Post-PACU) | 1.36 ± 0.66 | 1.65 ± 0.87 | 1.80 ± 0.88 | 0.036 |
| NRS Score at Rest (24h Post-PACU) | 1.56 ± 1.01 | 1.61 ± 0.96 | 1.85 ± 1.09 | 0.385 |
| NRS Score on Movement (24h Post-PACU) | 2.44 ± 1.34 | 2.55 ± 1.27 | 2.39 ± 1.42 | 0.884 |
| Sleep Quality from Baseline | −0.8±1.03 | −0.4±1.2 | 0.1±1.5 | <0.001 |
| QoR-15 Score on Postoperative Day 1 | 141 ± 10 | 139 ± 11 | 139 ± 14 | 0.715 |
| QoR-15 Score on Postoperative Day 2 | 145 ± 5 | 144 ± 6 | 143 ± 10 | 0.226 |
| Time to First Ambulation (h) | 14.1 ± 2.5 | 16.7 ± 6.5 | 20.0 ± 6.2 | <0.001 |
| MMSE change from baseline | −2.1±2.27 | −2.6±1.9 | −1.9±2.5 | 0.249 |
Table 6.
Pairwise Intergroup Comparisons with Effect Sizes for Postoperative Analgesia and Recovery Indicators
| Effect Size or OR (95% CI) | P-value | |
|---|---|---|
| Total Morphine Equivalents Consumption | ||
| BP Group vs Control Group | 5.72 (2.89, 8.18) | <0.001 |
| LB Group vs Control Group | −7.18 (−9.62, −4.23) | <0.001 |
| BP Group vs LB Group | −1.64 (−4.35, 0.96) | 0.507 |
| NRS Score at Rest (8h Post-PACU) | ||
| BP Group vs Control Group | 0.33 (0.12, 0.51) | 0.014 |
| LB Group vs Control Group | −0.48 (−0.67, −0.24) | <0.001 |
| BP Group vs LB Group | −0.14 (−0.39, 0.08) | 0.382 |
| NRS Score on Movement (8h Post-PACU) | ||
| BP Group vs Control Group | 0.17 (−0.14, 0.52) | 0.721 |
| LB Group vs Control Group | −0.34 (−0.68, −0.11) | 0.023 |
| BP Group vs LB Group | −0.36 (−0.50, 0.13) | 0.380 |
| Sleep Quality from Baseline | ||
| BP Group vs Control Group | 0.71 (0.35, 1.11) | <0.001 |
| LB Group vs Control Group | −0.88 (−1.27, −0.68) | <0.001 |
| BP Group vs LB Group | −0.18 (−0.53, 0.25) | 0.632 |
| Time to First Ambulation (h) | ||
| BP Group vs Control Group | 3.17 (1.19, 5.42) | 0.029 |
| LB Group vs Control Group | −5.68 (−7.69, −3.62) | <0.001 |
| BP Group vs LB Group | −2.32 (−4.47, −0.54) | 0.057 |
Notes: Adjusted for surgery time. The data are given as mean ± SD. The opioids conversion method: Morphine 10 mg IV = Morphine 10 mg IM = Morphine 30 mg PO = remifentanil 10 μg IV = Fentanyl 0.1 mg IV = Sufentanil 10 μg IV = Hydromorphone 1.5 mg IV = Oxycodone 10 mg IV = Oxycodone 20 mg PO = Butorphanol 2 mg IV = Tramadol 100 mg IV = Pethidine 100 mg IV = Dezocine 10 mg IV.
Abbreviations: PACU, postanaesthesia care unit; LB, liposomal bupivacaine; BP, bupivacaine.
Discussion
In this single-center, randomized controlled trial of elderly patients undergoing laparoscopic inguinal hernia repair, we found that TAP+RSB using LB significantly reduced perioperative opioid consumption compared with both plain bupivacaine and no block. Although a universally accepted Minimal Clinically Important Difference (MCID) for 48-hour postoperative morphine consumption remains undefined, evidence suggests that even modest reductions are clinically valuable in the elderly. Given the heightened sensitivity of the geriatric population, the reduction of 6–7 mg of intravenous morphine equivalents over 48 hours constitutes a meaningful decrease in cumulative opioid load, which is directly aligned with Enhanced Recovery After Surgery (ERAS) principles. Beyond opioid sparing, the early establishment of analgesia attenuates the surgical stress response and blunts acute pain upon emergence. This synergy allows for lighter overall anesthetic management and explains the accelerated recovery profile observed in the block groups. The LB group also demonstrated prolonged analgesia duration, faster time to first ambulation, shorter hospital stay, and lower postoperative pain scores, particularly at rest and early time points. Importantly, the use of LB was not associated with an increased incidence of adverse events and resulted in high patient satisfaction with analgesia. These findings suggest that LB-based regional anesthesia may provide meaningful benefits in enhancing postoperative pain control and recovery in the elderly surgical population.
Several previous studies have investigated the use of LB for abdominal wall blocks in hernia or related surgeries, with variable outcomes. Fayezizadeh et al reported that TAP blocks with LB reduced postoperative opioid requirements and pain scores in patients undergoing open abdominal wall reconstruction.16 Aasbø et al demonstrated improved analgesia following LB infiltration in open inguinal hernia repair, though no regional block was used.17 In contrast, Nedeljkovic et al found no significant advantage of LB over plain bupivacaine for TAP blocks after caesarean delivery, possibly due to differences in surgical type, block technique, or population characteristics.6 It is noteworthy that most prior studies involved either younger adult populations or non-standardized regional techniques. Few have focused specifically on older adults or combined TAP and RSB blocks. Our trial adds to the current literature by evaluating a dual-plane LB block in elderly patients undergoing laparoscopic inguinal hernia repair, demonstrating consistent reductions in opioid consumption and enhanced early recovery metrics.
The analgesic benefits observed with LB in this study may be attributed to its extended-release formulation and the anatomical coverage achieved by dual-plane blockade. LB is encapsulated in multivesicular liposomes, allowing for gradual release of bupivacaine over 72–96 hours, thereby sustaining analgesia well beyond the typical 6–8 hour duration of plain bupivacaine.18,19 This prolonged effect is particularly advantageous in elderly patients, who are often more sensitive to opioid-related adverse effects and may benefit from a longer opioid-sparing window. In addition, the combination of TAP and rectus sheath blocks provides wider somatic analgesia of the lower abdominal wall, effectively covering both the lateral and midline incisions commonly used in laparoscopic hernia repair.20,21 The reduced need for rescue analgesia and improved recovery metrics observed in the LB group may therefore reflect both pharmacokinetic advantages and optimized anatomical targeting. The shorter postoperative hospital stay in the LB group may be attributed to well-controlled postoperative pain, enabling earlier ambulation. These findings support the rationale for regional techniques that extend beyond single-plane blocks, particularly in high-risk populations.
In our study, we found that the surgical duration in the LB group was significantly longer than in the control group (P=0.017). Although the difference was modest, longer surgery times could potentially influence postoperative outcomes, including increased opioid consumption and pain. We acknowledge that prolonged surgery duration may contribute to delayed recovery, especially in elderly patients, and could lead to increased requirements for analgesics. However, it is important to note that despite the longer surgical duration, the LB group demonstrated significantly reduced opioid consumption and improved recovery, suggesting that the benefits of LB in terms of analgesia and recovery may have outweighed the potential disadvantages associated with longer surgery times.
We had not initially included surgical duration as a covariate in our primary sensitivity analysis. However, we have since conducted additional sensitivity analyses adjusting for surgery duration to assess whether it influenced opioid consumption and recovery outcomes. The results of this additional analysis did not alter the overall conclusions, with the LB group still showing superior outcomes in terms of opioid reduction and recovery, even after adjusting for surgical duration.
These additional findings indicate that, even with a longer surgery time, LB still significantly improved postoperative recovery and reduced opioid consumption. Therefore, the extended surgical duration did not significantly impact the efficacy of LB in improving recovery.
This study possesses several strengths. It was a randomized controlled trial with clearly defined eligibility criteria, standardized anesthetic protocols, and blinding of outcome assessment, thereby minimizing selection and performance bias. The use of both TAP+RSB reflects a comprehensive regional analgesia approach relevant to the anatomical innervation involved in laparoscopic inguinal hernia repair. Although LB has a higher acquisition cost, the 1-day reduction in LOS (if consistent in real-world practice) could offset this expense. A formal cost-effectiveness analysis was beyond the scope of this study but warrants future investigation. Furthermore, the trial focused on a relatively understudied and clinically vulnerable population—older adults—who may particularly benefit from opioid-sparing analgesic strategies.
Nonetheless, several limitations should be acknowledged. First, this was a single-center trial, which may limit generalizability of the findings to broader surgical populations or practice settings. Second, although blinding of outcome assessors was maintained, complete blinding of the anesthetist performing the block was not feasible. Third, we did not include pharmacoeconomic analyses, and the higher acquisition cost of LB remains a potential barrier to widespread adoption. Lastly, follow-up was limited to the in-hospital period; longer-term outcomes, including persistent postoperative pain or functional recovery, were not assessed.
Conclusion
In elderly patients undergoing laparoscopic inguinal hernia repair, the use of combined TAP+RSB with LB significantly reduced perioperative opioid consumption and improved early postoperative recovery without increasing adverse events. These findings support the use of LB-based regional anesthesia as an effective component of multimodal analgesia in this population. Further multicenter trials with longer follow-up are warranted to confirm these results and evaluate cost-effectiveness.
Acknowledgment
An unauthorized version of the Chinese MMSE was used by the study team without permission, however this has now been rectified with PAR. The MMSE is a copyrighted instrument and may not be used or reproduced in whole or in part, in any form or language, or by any means without written permission of PAR (www.parinc.com).
Funding Statement
This work was supported by Natural Science Foundation of Shanghai (Project’s number: 23ZR1462800) and Noncommunicable Chronic Diseases-National Science and Technology Major Project (2024ZD0527201).
Data Sharing Statement
Deidentified individual participant data (including data dictionaries) will be made available upon request to the corresponding author following publication for a period of 5 years. Supporting documents will include the study protocol and statistical analysis plan.
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 report no conflicts of interest in this work.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
Deidentified individual participant data (including data dictionaries) will be made available upon request to the corresponding author following publication for a period of 5 years. Supporting documents will include the study protocol and statistical analysis plan.