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

NCT07512635 | Not Yet Recruiting Phase 4

• 1 other identifier: Ming-Yi-Yuan-Ethics-2024-54/02
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pulmonary Nodule; Liposomal Bupivacaine

Keywords

Liposomal bupivacaine; Intercostal nerve block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Postoperative Quality of Recovery at 48 hours

  48 hours after surgery

• Area Under the Curve (AUC) of Pain Scores in the First 48 Hours

  From PACU arrival to 48 hours post-PACU arrival (assessed at 8 time points)

• Cumulative Morphine Consumption in the First 48 Hours

  First 48 hours after surgery

• Time to First PCA Demand

  Up to 48 hours

• Patient Satisfaction

  48 hours after surgery

Other Outcomes (1)

• Incidence of Adverse Events

  First 48 hours after surgery

Study Arms (2)

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.

Drug: Bupivacaine Hydrochloride

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.

Drug: Bupivacaine liposome

Interventions

Bupivacaine liposome DRUG

Single-dose, pre-procedural intercostal nerve block with bupivacaine liposome, administered by thoracoscopy prior to surgery.

Also known as: Exparel, liposomal bupivacaine

Liposome bupivacaine group

Bupivacaine Hydrochloride DRUG

Single-dose, pre-procedural intercostal nerve block with bupivacaine hydrochloride, administered by thoracoscopy prior to surgery.

Also known as: Marcaine, Sensorcaine

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Sanming First Hospital: lead

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Huifen Lin, MD

  No. 15, Liedong Street, Sanyuan District, Sanming City, Fujian Province

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huifen Lin, MD

CONTACT

（0598）8803263; smyhb0598@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 6, 2026
• Study Start: April 6, 2026
• Primary Completion: April 7, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We would like to share our individual deidentified participant data beginning three months following the publication of the main results.
• 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.