Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Quality of Recovery in VATS Partial Pneumonectomy

Effect of Intercostal Nerve Block With Liposomal Bupivacaine on Postoperative Quality of Recovery in Patients Undergoing Video-assisted Thoracoscopic Partial Pneumonectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Nodule; Liposomal Bupivacaine
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Drug: Bupivacaine liposome

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Huifen Lin, MD; Phone Number: （0598）8803263; Email: smyhb0598@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients scheduled for thoracic surgery under general anesthesia via thoracoscopic approach;
• Age 18-65 years;
• Classified as Grade I-II by the American Society of Anesthesiologists (ASA).

Exclusion Criteria:

• History of local anesthetic allergy.
• Chronic opioid users.
• Contraindications for nerve block, including infection at the puncture site and coagulation disorders;
• Language communication impairment.
• Other conditions unsuitable for inclusion in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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.	Drug: Bupivacaine Hydrochloride; Single-dose, pre-procedural intercostal nerve block with bupivacaine hydrochloride, administered by thoracoscopy prior to surgery.; Other Names: Marcaine, Sensorcaine
Experimental: Liposome bupivacaine group; 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.	Drug: Bupivacaine liposome; Single-dose, pre-procedural intercostal nerve block with bupivacaine liposome, administered by thoracoscopy prior to surgery.; Other Names: Exparel, liposomal bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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)

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sanming First Hospital
• Investigators: Principal Investigator: Huifen Lin, MD, No. 15, Liedong Street, Sanyuan District, Sanming City, Fujian Province

Study record dates

Study Major Dates

• Study Start (Estimated): April 6, 2026
• Primary Completion (Estimated): April 7, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Liposomal bupivacaine; Intercostal nerve block
• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Bupivacaine
• Other Study ID Numbers: Ming-Yi-Yuan-Ethics-2024-54/02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: We would like to share our individual deidentified participant data beginning three months following the publication of the main results.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No