Abstract
Background
Despite the widespread adoption of uniportal video-assisted thoracoscopic surgery (VATS), postoperative pain associated with this procedure remains a significant concern. Effective postoperative analgesia is essential for facilitating the recovery of patients undergoing thoracic surgery. Thoracic paravertebral block (TPVB) is widely recognized as an extremely effective method of analgesia in such surgeries. Our previous study has demonstrated that the diffusion of local anesthetic during nerve blocks is related to body position. Therefore, this study aimed to evaluate the impact of thoracic paravertebral nerve block in various body positions on the analgesic outcomes for patients undergoing single-port thoracoscopic lung resection.
Methods
A randomized controlled trial was conducted to assess the impact of different body positions during thoracic paravertebral nerve blocks on the analgesic effect in patients undergoing single-port thoracoscopic partial lung resection. Patients scheduled for thoracoscopic lung resection will be included in this study. Participants (n = 200) will undergo thoracic paravertebral nerve block under ultrasound guidance. After the injection of the drug, they will be placed in either a supine position or a lateral position with the puncture side up. The NRS scores will be assessed at 1 h, 2 h, 8 h, 12 h, 24 h, and 48 h postoperatively. Postoperative opioid consumption, rescue analgesia time and frequency, patient satisfaction, incidence of adverse reactions, and length of hospital stay will also be recorded.
Discussion
This research project mainly aimed to investigate the impact of different perioperative positions for thoracic paravertebral nerve block on the analgesic effects in patients undergoing single-port thoracoscopic lung resection. The results may provide important implications for the development of effective analgesic strategies and robust clinical evidence to support the recovery of patients undergoing thoracic surgery.
Trial registration
ClinicalTrials.gov NCT06789276. Registered on 10 January 2025.
Supplementary Information
The online version contains supplementary material available at 10.1186/s13063-025-09198-7.
Keywords: Thoracic paravertebral nerve block, Position, Analgesic effect, Randomized controlled trial
Background
Thoracic surgery is a specialized field that focuses on the diagnosis and treatment of diseases of the chest organs, primarily the lungs, esophagus, and mediastinum. This includes conditions such as chest trauma, lung and esophageal tumors, chronic obstructive pulmonary disease, tuberculosis, esophageal functional disorders, diaphragmatic diseases, and congenital chest diseases. A significant number of patients worldwide require thoracic surgical procedures [1]. Thoracic surgery is widely recognized as one of the most painful surgical procedures. Compared to open thoracotomy, video-assisted thoracoscopic surgery (VATS) offers similar therapeutic outcomes with less invasiveness, significantly reducing postoperative pain and promoting recovery [2, 3]. Despite the use of video-assisted thoracoscopic surgery (VATS), a significant proportion of patients still experience considerable discomfort. Specifically, 78% of patients report moderate to severe pain, with 27% experiencing moderate pain, 34% severe pain, and 17% very severe pain [4, 5]. Effective postoperative analgesia is a key factor in accelerating perioperative recovery. Thoracic epidural block (TEB) is considered the gold standard for analgesia in thoracic surgery. However, complications such as hypotension and nerve damage have been persistent issues. The growing application of ultrasound in anesthesiology has highlighted the importance of regional anesthesia in multimodal analgesia strategies. This approach is vital for enhancing the recovery of patients undergoing thoracic surgery. In the realm of regional anesthesia, advancements have provided anesthesiologists with additional options, such as traditional thoracic epidural block and ultrasound-guided thoracic paravertebral block, which have emerged as valuable techniques in recent years [6]. Thoracic paravertebral block (TPVB) is currently recognized as the optimal alternative to TEB, as it provides comparable analgesic efficacy while offering enhanced safety [7, 8]. The utilization of thoracic paravertebral block in thoracic surgery is widely acknowledged for its effectiveness in providing analgesia, mitigating inflammatory responses, and reducing the incidence of chronic postoperative pain [9, 10].
A thoracic paravertebral injection may remain localized to the injection site [11], or it may spread to adjacent levels above and below, the lateral intercostal space, the medial epidural space, or a combination of these areas [12–14]. This is the way in which somatic and sympathetic nerves (including posterior primary branches) on the same side are affected across multiple consecutive thoracic segments [12]. The role of epidural spread in the extension of sensory block following thoracic paravertebral injection remains unclear. Most (70%) patients exhibit some degree of epidural spread. However, the volume of the injection that enters the epidural space accounts for only a small fraction of the total injected volume and is limited to the injected side. The sensory block is also unilateral, and the sensory block following epidural spread is greater than that following solely paravertebral spread [15, 16]. Several studies have reported that the analgesic area is related to the spread of local anesthetic [8, 17–20], our previous study has demonstrated that the diffusion of local anesthetic during nerve blocks is related to body position. However, there have been no reports to date on the effects of different body positions during ultrasound-guided thoracic paravertebral nerve block on postoperative analgesia. Therefore, a randomized controlled trial is designed to evaluate the impact of thoracic paravertebral nerve block in various body positions on the analgesic outcomes for patients undergoing single-port thoracoscopic lung resection.
Methods
Participants, interventions and outcomes
Study setting
This study will enroll approximately 200 participants from the Second Affiliated Hospital of Soochow University. This clinical trial has been approved and supported by The Ethics Committee of The Second Affiliated Hospital of Soochow University (JD-LK2023076-I01). Recruitment commenced on January 26, 2025. All eligible patients will be continuously enrolled until the recruitment process is complete. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist is provided as Additional file 1.
Eligibility criteria
Patients will be recruited primarily from the Second Affiliated Hospital of Soochow University. Table 1 presents a summary of the inclusion, exclusion, and termination criteria. The basic information of patients will be as shown in Table 2.
Table 1.
Inclusion/exclusion/termination criteria
| Inclusion criteria | Exclusion criteria | Termination criteria |
|---|---|---|
|
⑴ Age ≥ 18 and ≤ 70 years old ⑵ BMI ≥ 18 and ≤ 28 ⑶ American Society of Anesthesiologists (ASA) physical status classification I–II ⑷ Patients scheduled for elective thoracoscopic lung resection (including lobectomy, segmentectomy, and wedge resection) ⑸ Patients who agree to participate in this study and sign the informed consent form |
⑴ Patients who refuse to undergo nerve block ⑵ Patients with severe cardiac, pulmonary, hepatic, or renal insufficiency requiring postoperative admission to the ICU for continued treatment (EF < 40%, FEV1/FVC < 40%) ⑶ Abnormal coagulation function ⑷ History of allergy to anesthetic drugs ⑸ History of chronic alcohol use, chronic pain, or long-term use of psychotropic medications ⑹ Scars, infections, or tumors at the puncture site ⑺ History or family history of malignant hyperthermia ⑻ Refusal to participate in this study or inability to cooperate with follow-up or poor compliance |
⑴ Failure to comply with the predetermined study protocol ⑵ Occurrence of local anesthetic adverse reactions, puncture needle entering the pleural cavity, or other complications during puncture ⑶ Changes in the patient’s condition ⑷ The patient’s unwillingness to continue participating in the study |
Table 2.
Patient characteristics and baseline data
| Characteristics | Supine group | Lateral decubitus group |
|---|---|---|
| Male/female | ||
| Age, years | ||
| Body mass index (BMI), kg/m2 | ||
| Predicted body weight, kg | ||
| American Society of Anesthesiologists (ASA) physical status, I/II |
Recruitment and informed consent
Figure 1 outlines the timeline of main research activities for each study visit. Patients scheduled for thoracoscopic lung resection will be included in this study. The study has been approved by the Ethics Committee of the Second Affiliated Hospital of Soochow University. The surgery will be conducted within 2 days following the screening process. Designated physicians will provide a detailed explanation of the trial to interested potential participants and offer them an informed consent form. Participants will have at least 24 h to decide whether to participate in the trial. The informed consent form will be signed by the participant or their proxy or guardian and can be withdrawn at any time during the trial. Written informed consent and baseline data from the patients will be obtained prior to randomization. Furthermore, participants are encouraged to contact the research team if they encounter any health issues during the trial. The recruitment and consent of study participants by the research team members are conducted in compliance with Good Clinical Practice (GCP). During the clinical trial, researchers will promptly report any serious adverse events experienced by the subjects to the director in charge of the clinical trial of the research institution and contact Professor Hong Xie or Dr. Xuejiao Zhu, regardless of their relation to the study.
Fig. 1.
Schedule of enrollment, interventions and assessments
Allocation
Subjects will be randomly assigned to one of the following two groups: supine group and lateral decubitus group. Randomization will be conducted using SAS software, with a 1:1 allocation ratio for group randomization. A random code will be generated between the supine group and lateral decubitus group, in a 1:1 ratio. Sealed, opaque, and stapled envelopes containing randomization codes will be generated and distributed to designated staff assistants. These assistants will assign body postures based on the random numbers and allocate a code to each posture. The envelopes will not be opened until the registered participants have completed the trial. After entering the study, each participant will be assigned to either the supine group or the lateral decubitus group with equal probability.
Intervention
Patients are positioned in the lateral decubitus position, and the T5 level is located and marked using ultrasound. The area is disinfected and draped as usual, and the ultrasound probe is covered with a sterile sheath. Under ultrasound guidance, a thoracic paravertebral nerve block is performed on the affected side. The ultrasound is set to the short-axis view of the spine, and the scanning plane is gradually adjusted to be parallel to the intercostal space, avoiding the ribs. Within the same plane, the transverse process and pleura are visualized. Using an in-plane technique, the needle is inserted from the outer side of the probe. When the needle tip reaches the parapleural space, the depression of the pleura is observed on ultrasound, indicating that the needle tip has reached the target point. A total of 30 ml of 0.25% ropivacaine is administered. Immediately after the injection, the patient is positioned in the required position (supine or lateral decubitus with the puncture side up).
Both groups of patients undergo double-lumen bronchial tube intubation under general anesthesia. Induction is performed using propofol 1.5–2.0 mg/kg, sufentanil 0.1–0.3 µg/kg, rocuronium 0.6–1.0 mg/kg, and methylprednisolone sodium succinate 40 mg. Maintenance of anesthesia is achieved with sevoflurane and remifentanil at 0.1–0.5 µg/kg/min (adjusted according to the patient’s heart rate and blood pressure, with BIS maintained at 40–60), and rocuronium is administered intermittently to maintain muscle relaxation during surgery. Postoperatively, both groups of patients receive patient-controlled analgesia pumps with sufentanil (3.5 μg/kg).
Interventions, modifications, adherence and concomitant care
The designated interventions will only be halted in response to participant requests. There are no planned modifications to the interventions during the trial. Compliance with the interventions primarily refers to the patient’s adherence to self-management. No concomitant care or interventions are allowed during this trial.
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use
We have no plans to collect or store biological specimens in this trial.
Outcomes
Primary outcome measures
Primary outcome of this study is to assess the patients’ pain levels at 1 h, 2 h, 8 h, 12 h, 24 h, and 48 h for static (lying or sitting) and dynamic (coughing) conditions, using the Numeric Rating Scale (NRS) scores.
Secondary outcome measures
Secondary outcomes comprise the following:
Postoperative opioid consumption: The total amount of opioids (such as sufentanil) used by patients within 24 h postoperatively will be recorded.
Rescue analgesia time and frequency: The time at which the patient first requests rescue analgesia and the total number of rescue analgesia administrations will be recorded as indicators of when the analgesic effect of the drug begins to wane.
Patient satisfaction: Standardized questionnaires will be used to assess patient satisfaction with the analgesic effect at 24 and 48 h postoperatively.
Incidence of adverse reactions: Adverse reactions such as nausea, vomiting, dizziness, somnolence, and respiratory depression that occur within 24 and 48 h postoperatively will be recorded.
Length of hospital stay: The length of hospital stay will be recorded to evaluate the impact of the analgesic effect on postoperative recovery.
Participant timeline
Figure 1 presents the schedule for enrolment, interventions, assessments, and visits for participants.
The NRS score, which stands for Numeric Rating Scale, is a widely utilized pain assessment tool in clinical settings. It typically employs a numerical range from 0 to 10, with 0 signifying no pain and 10 representing the most intense pain. Patients are asked to select a number on this scale based on their own perception to describe the intensity of their pain. Specifically, a score of 0 means no pain, 1–3 indicates mild pain that does not affect sleep, 4–6 indicates moderate pain that affects sleep, and 7–10 indicates severe pain that significantly affects sleep. The NRS scores will be assessed at 1 h, 2 h, 8 h, 12 h, 24 h, and 48 h postoperatively.
By comparing the opioid consumption between two groups of patients, it is possible to determine which treatment plan is more effective in controlling postoperative pain. The amount of opioid consumption can indirectly reflect the postoperative recovery status of patients. Lower consumption generally indicates better pain control and better recovery. Reducing the use of opioids can decrease the incidence of adverse reactions such as postoperative nausea, vomiting, and respiratory depression, thereby improving the postoperative quality of life of patients. Postoperative sufentanil consumption will be recorded in the first 24 h.
Standardized questionnaires will be used to assess patient satisfaction with the analgesic effect at 24 and 48 h postoperatively. The patient satisfaction survey questionnaire mainly includes the patient’s basic information, assessment of analgesic effects, evaluation of analgesic services, and other opinions and suggestions.
Adverse reactions such as nausea, vomiting, dizziness, somnolence, and respiratory depression that occur within 24 and 48 h postoperatively will be recorded.
The length of hospital stay will be recorded to evaluate the impact of the analgesic effect on postoperative recovery. By analyzing the length of hospital stay, a comprehensive assessment of the quality of medical services can be conducted, treatment processes can be optimized, and the quality of postoperative recovery and patient satisfaction can be improved.
Sample size
The sample size for this study was calculated based on a preliminary study with 10 patients per group. The average consumption of sufentanil in the supine group and the lateral decubitus group was 50.0 ± 10.4 μg and 43.6 ± 11.2 μg, respectively. Given a power of 1 − β = 0.80 and a two-sided α level of 5%, assuming a dropout rate of 10%, each group should have no fewer than 100 patients.
Allocation masking
This study is designed to employ a double-blind methodology. In all instances, researchers, attending anesthesiologists during surgery, evaluators, and data analysts will remain unaware of the treatment allocation. This is ensured as the interventions will be packaged and administered by independent personnel, thereby maintaining the integrity of the blinding process.
Unblinding procedures
In the event of a medical emergency where it is necessary to determine the treatment status of an individual patient, investigators will be permitted to open the corresponding emergency envelope. The rationale for this action must be documented in the patient’s medical record and case report form (CRF). At the end of the trial, serious adverse events will be collected and recorded for further analysis, and researchers will explore the correlation between these events and the patients’ medical records.
Plans for communicating important protocol modifications to relevant parties
All amendments to the study protocol will be reviewed by the ethics committee and reported to the sponsor, participating care providers, and researchers.
Composition of the data-monitoring committee, its role and reporting structure
We have not considered there to be a need for a data monitoring committee.
Interim analyses
No formal interim analysis of the primary and secondary outcomes is planned.
Frequency and plans for auditing trial conduct
We have no plans for auditing trial conduct in this investigator-initiated pragmatic trial.
Data management
All patient data collected during this clinical study will be entered and/or archived in the corresponding patient’s case report form (CRF).
Participation of patients in the study must be appropriately documented in the patient's CRF, including the study number, subject number, subject information date, informed consent form, and dates of each visit. Source data should be archived in accordance with Good Clinical Practice (GCP) guidelines. The data manager will be responsible for data processing in accordance with the sponsor’s standard operating procedures and will conduct regular monitoring to ensure that the data are complete, accurate, and reliable. Database lock will only occur after the completion of quality assurance procedures.
Statistical analysis
Statistical analysis will be conducted using SPSS 30.0 (IBM Inc., Armonk, NY, USA). Continuous variables will be analysed using the unpaired t test or Mann–Whitney U test. Categorical variables will be analysed using the χ2 test, continuity correction χ2 test, or Fisher exact test. A P value < 0.05 will be considered statistically significant. After the completion of the trial, the corresponding author will provide the statistical code generated during this study upon reasonable request.
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data
Statistical analyses will be conducted on an intention-to-treat (ITT) basis. Outcome analyses will be performed as randomized analyses, regardless of protocol adherence. All variables will be screened for frequency and types of missingness. If the missing rate for any variable exceeds 5%, multiple imputation will be employed. In cases where data are missing and imputation is applied, a complete case analysis will be conducted as a sensitivity analysis.
Composition of the coordinating center and trial steering committee
The principal investigator, Hong Xie (HX), is responsible for preparing and revising the protocol and disseminating any changes. Xuejiao Zhu (XJZ) is responsible for coordinating data collection and analysis and for drafting the scientific manuscript. The senior researcher, Jiang Zhu (JZ), is responsible for overseeing the study design, protocol, and interpretation of results. The statistician, Lingwei Zhang (LWZ), is responsible for supervising all statistical analyses. The clinical researchers, Peng Peng (PP), Jia Guo (JG), and Hao Zhong (HZ), are responsible for overseeing the on-site implementation of the study to ensure compliance with the protocol.
Dissemination plans
The results of the study will be disseminated through publications in peer-reviewed journals.
Additional consent provisions regarding the collection and use of participant data and biological specimens
There are no plans for ancillary studies, nor do we intend to collect any additional participant data or biological specimens beyond those specified in this protocol.
Adverse event reporting and harms
Ropivacaine, a long-acting local anesthetic, is extensively used in various surgical procedures and pain management. Due to its minimal toxicity to the central nervous system and cardiovascular system, it offers a high level of safety in clinical settings. Ultrasound-guided thoracic paravertebral nerve block is an invasive procedure that may be associated with complications such as hematoma, pneumothorax, infection, and nerve damage. We will assess any potential harm resulting from the intervention. Additionally, there is a dedicated commentary section in the study-specific case report forms (CRFs) where researchers can document any protocol deviations or unexpected side effects from the allocated interventions. We will collect all expected and unexpected drug-related adverse events in a non-systematic manner and report all identified harms in the trial publications.
Provisions for posttrial care
If participants are injured due to this study, in case of damage related to clinical research, they will get free treatment.
Discussion
According to the data from the American Lung Cancer Association in 2020, lung cancer accounts for 25% of all cancer-related deaths, with 84% of these cases being non-small cell lung cancer (NSCLC) [21]. Thoracic surgery, including lobectomy, remains a primary treatment option for NSCLC. However, this type of surgery is associated with severe postoperative complications such as respiratory distress, bleeding, and pain. It can also impact the body’s immune function, leading to neuroendocrine disorders, which in turn can significantly impair the patient’s quality of life. Furthermore, severe pain can trigger the release of large amounts of catecholamines, which can inhibit the mononuclear–phagocyte system and potentially lead to tumor cell escape [22, 23]. Therefore, how to better control the perioperative analgesia of thoracic surgery patients is an important challenge faced by clinicians. In recent years, preemptive analgesia, as a pain management strategy that prevents the transmission of peripheral injury impulses to the central nervous system, has gradually been applied in clinical anesthesia [24].
Epidural blockade is a frequently employed analgesic technique in thoracic surgery. However, its clinical use is often limited due to the risk of complications such as spinal cord injury and total spinal anesthesia [25]. Paravertebral block (PVB) involves the injection of local anesthetics into the paravertebral space, aiming to block the neural conduction of pain by targeting the spinal dorsal root ganglia, thereby inhibiting the ipsilateral somatic and sympathetic nerves. Furthermore, with the aid of ultrasound technology, the anatomical structures surrounding the paravertebral space can be visualized clearly, which enhances the success rate and reduces the incidence of related complications [26]. Research has shown that although opioid-based general anesthesia provides effective analgesia, the use of high doses of opioids often results in adverse reactions such as nausea, vomiting, drowsiness, and dizziness. When combined with paravertebral nerve block anesthesia, the dosage of opioids can be significantly reduced, thereby facilitating the early recovery of patients’ functional and cognitive levels [27]. Studies have demonstrated that ultrasound-guided nerve blocks can effectively reduce the surgical trauma and post-traumatic stress response associated with direct vision anesthesia blocks. Additionally, they can help stabilize arterial blood pressure fluctuations during surgery, maintaining the stability of vital signs in the perioperative period [26, 27]. NeMoyer et al. have noted that paravertebral nerve blocks can effectively block the transmission of peripheral noxious stimuli to the central nervous system, reducing the degree of central nervous sensitization and the patient’s pain sensitivity, ultimately achieving the effect of pain relief [28].
Thoracic paravertebral block (TPVB) is a procedure where local anesthetics are injected into the thoracic paravertebral space. The anesthetic directly acts on the spinal nerve roots, effectively blocking neural conduction. The solution can also spread laterally along the intercostal nerves, impacting adjacent intercostal spaces. Moreover, it can migrate through the intervertebral foramina into the epidural space, influencing a wider range of nerve segments. Additionally, the anesthetic can disperse longitudinally within the thoracic paravertebral space, affecting multiple nerve root segments [29, 30].
In our preliminary studies, our research team injected 40 ml of 0.375% ropivacaine solution (containing 30 mg/ml iohexol contrast agent) into the thoracic paravertebral space. Immediately following the injection, patients were positioned in various required postures (supine, lateral decubitus with the puncture side up, or prone). A CT scan of the chest was conducted to assess the distribution of the contrast agent along the longitudinal axis, identifying the highest and lowest levels reached. The distribution range of the contrast agent was also quantified at each level where the contrast agent was present. We observed that the distribution of the drug solution varied under different postures. Therefore, we hypothesize that by altering the patient’s position, anesthesiologists can control the spread of the drug solution, thereby improving the anesthetic effect and enhancing the quality of pain relief for patients.
This will be the first randomized controlled trial to investigate the impact of different perioperative positions for thoracic paravertebral nerve block on the analgesic effects in patients undergoing single-port thoracoscopic lung resection. Our aim is to offer superior analgesic strategies and robust clinical evidence to support the recovery of patients undergoing thoracic surgery.
Trial status
Trial registration: ClinicalTrials.gov, NCT06789276. Registered on 10 January 2025.
The protocol version is 6.1.0, which was approved in August 2023. This study started in January 2025, and the recruitment phase will last until August 2025.
Supplementary Information
Additional file 1. SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents
Additional file 2. Supplemental table: Items from the World Health Organization Trial Registration Data Set
Acknowledgements
Our team would like to thank all of the staff at all participating sites and the patients who have participated in the trial to date.
Abbreviations
- VATS
Video-assisted thoracoscopic surgery
- TPVB
Thoracic paravertebral block
- TEB
Thoracic epidural block
- GCP
Good Clinical Practice
- NRS
Numeric Rating Scale
- CRF
Case report form
- ITT
Intention-to-treat
- NSCLC
Non-small cell lung cancer
- PVB
Paravertebral block
Authors’ contributions
HX conceived the study idea. HX and JZ led the proposal and design of the study and developed the protocol, the trail database and case report forms. XJZ is the first author and contributed to the final manuscript. PP and JG participated in performing the experiment and collection of data. LWZ and HZ contributed to the sample size estimations and statistical design of the RCT. HX and JZ were responsible for the conception and design of the study. All authors have read and approved the final manuscript. The authorship for future trial publications would be assigned according to the contribution. And we have no plan for using of professional writers.
Funding
This study was not funded.
Data availability
The participant-level data set cannot be made publicly available because of Chinese data protection rules and regulations. The statistical code is available upon request.
Declarations
Ethics approval and consent to participate
This clinical trial was approved and supported by the Ethics Commission of The Second Affiliated Hospital of Soochow University (JD-LK2023076-I01).
Consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
Footnotes
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Contributor Information
Jiang Zhu, Email: zhujiangsz@126.com.
Hong Xie, Email: hongx93044@126.com.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Additional file 1. SPIRIT 2013 checklist: recommended items to address in a clinical trial protocol and related documents
Additional file 2. Supplemental table: Items from the World Health Organization Trial Registration Data Set
Data Availability Statement
The participant-level data set cannot be made publicly available because of Chinese data protection rules and regulations. The statistical code is available upon request.