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Video-assisted thoracoscopic surgery (VATS) is a minimally invasive approach for partial pneumonectomy, but postoperative pain remains a major challenge affecting recovery. Intercostal nerve block (ICNB) with conventional local anesthetics provides limited duration of analgesia, often insufficient to cover the peak pain period after surgery. Liposomal bupivacaine is a long-acting formulation designed to provide extended analgesia up to 72 hours. This study aims to evaluate the effect of preoperative ICNB with liposomal bupivacaine compared with conventional bupivacaine hydrochloride on postoperative quality of recovery in patients undergoing VATS partial pneumonectomy. The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours postoperatively. We hypothesize that liposomal bupivacaine ICNB results in superior recovery quality compared with conventional bupivacaine, with reduced postoperative pain and opioid consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 30 mL of 0.25% bupivacaine hydrochloride was administered by the surgeon under thoracoscopy to perform intercostal nerve block at the 3rd to 8th intercostal spaces, with 5 mL injected into each intercostal space prior to the start of the procedure. |
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| Liposome bupivacaine group | Experimental | A 30 mL solution was prepared by diluting 15 mL of bupivacaine liposome with 15 mL of 0.9% sodium chloride. Prior to the procedure, the surgeon performed intercostal nerve blockage at the 3rd to 8th intercostal spaces under thoracoscopy, injecting 5 mL into each intercostal space. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine Hydrochloride | Drug | Single-dose, pre-procedural intercostal nerve block with bupivacaine hydrochloride, administered by thoracoscopy prior to surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Quality of Recovery at 24 hours | Quality of Recovery-15 (QoR-15) questionnaire. The scale includes 15 items across 5 domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10 (0 = worst possible recovery; 10 = best possible recovery). Total score ranges from 0 to 150, with higher scores indicating better recovery. | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Quality of Recovery at 48 hours | Quality of Recovery-15 (QoR-15) questionnaire. The scale includes 15 items across 5 domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10 (0 = worst possible recovery; 10 = best possible recovery). Total score ranges from 0 to 150, with higher scores indicating better recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | All adverse events occurring within the first 48 hours after surgery are recorded using a standardized case report form (CRF). Adverse events are categorized by system organ class, severity, and relationship to the study intervention. | First 48 hours after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huifen Lin, MD | Contact | （0598）8803263 | smyhb0598@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huifen Lin, MD | No. 15, Liedong Street, Sanyuan District, Sanming City, Fujian Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SanMing First Hospital | Recruiting | Sanming | Fujian | China |
After publication, the individual deidentified participant data underlying published results, the study protocol, and the statistical analysis plan can be accessed upon reasonable request from the corresponding author.
We would like to share our individual deidentified participant data beginning three months following the publication of the main results.
All of the individual participant data collected during the trial, the study protocol, the statistical analysis plan, and the clinical study report can be accessed with approval from the corresponding author.
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine liposome | Drug | Single-dose, pre-procedural intercostal nerve block with bupivacaine liposome, administered by thoracoscopy prior to surgery. |
|
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| 48 hours after surgery |
| Area Under the Curve (AUC) of Pain Scores in the First 48 Hours | Pain intensity assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Assessments are performed at 0, 1, 3, 6, 12, 24, 36, and 48 hours after arrival in the post-anesthesia care unit (PACU), separately for pain at rest and pain during coughing (movement). AUC is calculated using the trapezoidal method. | From PACU arrival to 48 hours post-PACU arrival (assessed at 8 time points) |
| Cumulative Morphine Consumption in the First 48 Hours | Total cumulative morphine consumption (in mg) recorded from the patient-controlled analgesia (PCA) device during the first 48 hours after surgery. | First 48 hours after surgery |
| Time to First PCA Demand | Time interval from arrival in the post-anesthesia care unit (PACU) to the first demand dose of patient-controlled intravenous analgesia (PCIA). | Up to 48 hours |
| Patient Satisfaction | Patient satisfaction with postoperative analgesia assessed using a 5-point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied. | 48 hours after surgery |
| Duration of PACU Stay | Time interval from arrival in the post-anesthesia care unit (PACU) until the Aldrete score reaches ≥9. | From PACU arrival to Aldrete score ≥9, up to 1 hour |
| Emergence time | Time interval from discontinuation of anesthetic agents until the patient shows a purposeful response to verbal command. | Up to 1 hour |
| Intraoperative Remifentanil Consumption | Total intraoperative remifentanil consumption (in μg) from the start of anesthesia maintenance until the end of surgery. | Intraoperative period (from anesthesia maintenance initiation to end of surgery) |
| D000588 |
| Amines |