Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine

NCT07134660 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Phase

Not applicable

Started

2025-09-01

Last updated

2026-03-30

Condition(s) studied

Postoperative Pain, AcuteLung Cancer

Investigational drug(s) / intervention(s)

Liposomal Bupivacaine intercostal nerve blockBupivacaine Hydrochloride intercostal nerve blockStandard Postoperative Analgesia

Liposomal Bupivacaine intercostal nerve block: Ultrasound-guided intercostal nerve block with liposomal bupivacaine 266 mg (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia.

Bupivacaine Hydrochloride intercostal nerve block: Ultrasound-guided intercostal nerve block with 0.25% bupivacaine hydrochloride (20 mL total; 4 mL per intercostal space at the incision and adjacent spaces), performed at the end of surgery before emergence from anesthesia. All patients receive standard postoperative analgesia with intravenous patient-controlled opioid analgesia.

Standard Postoperative Analgesia: No intercostal nerve block. Patients receive standard postoperative analgesia consisting of an intravenous patient-controlled opioid pump per institutional protocol.

Study summary

This randomized controlled trial evaluates the analgesic effects of liposomal bupivacaine compared to bupivacaine hydrochloride in intercostal nerve block for patients undergoing thoracoscopic lung surgery. Postoperative pain remains a significant issue in thoracic procedures, often leading to complications like pneumonia or delayed recovery. The investigators hypothesize that liposomal bupivacaine, with its extended-release properties, will provide superior pain relief beyond 24 hours compared to standard bupivacaine or no block. Participants will be randomized 1:1:1 to liposomal bupivacaine group , bupivacaine hydrochloride group , or control group . Primary outcome is the area under the curve of pain scores from 25-72 hours post-surgery. Secondary outcomes include opioid consumption, recovery quality (QoR-15), and other complications.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: * Scheduled for elective unilateral thoracoscopic (VATS) lung surgery * Age 18 to 80 years * American Society of Anesthesiologists (ASA) physical status I-III Exclusion Criteria: * Contraindication to local anesthetics (infection at puncture site, allergy to local anesthetics, coagulopathy or other bleeding risk) * Sensory abnormalities in the planned chest-wall surgical area * Hepatic dysfunction (ALT \> 50 U/L, AST \> 40 U/L, or total bilirubin ≥ 19 μmol/L) or renal dysfunction (serum creatinine \> 112 μmol/L, BUN \> 7.1 mmol/L, or dialysis within 28 days before surgery) * Pregnancy, breastfeeding, women of childbearing potential not using adequate contraception, or planning pregnancy during the study period * Preoperative opioid use, history of chronic pain, or history of opioid abuse * Refusal to provide informed consent

Primary outcome measure(s)

Pain score area under the curve (AUC) from 25 to 72 hours postoperatively — 25 to 72 hours after the end of surgery
Area under the curve of postoperative pain intensity measured on the VRS. AUC is computed over the 25-72 h interval. Postoperative pain intensity assessed using the Verbal Response Scale (VRS), the score ranges from 0 to 10, with a total of 11 numbers corresponding to different pain levels: 0 indicates no pain; 1-3 indicates mild pain (tolerable and does not affect sleep); 4-6 indicates moderate pain (significant, affects sleep, and requires medication for relief); and 7-10 indicates severe pain (intense, intolerable, and severely affects life).

Trial sites (1)

Facility	City	Region	Status
Shanghai pulmonary hospital	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07134660 on ClinicalTrials.gov ↗ ← All trials in China