RecruitingNot ApplicableNCT07134660

Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine

Analgesic Efficacy Between Liposomal Bupivacaine and Bupivacaine Hydrochloride in Intercostal Nerve Block for Thoracic Surgery: A Multicenter Randomized Controlled Trial

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

210 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Postoperative Pain, Acute

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

Scheduled for elective unilateral thoracoscopic (VATS) lung surgery
Age 18 to 80 years
American Society of Anesthesiologists (ASA) physical status I-III

Exclusion Criteria6

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

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Interventions

PROCEDURELiposomal 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.

PROCEDUREBupivacaine 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.

OTHERStandard Postoperative Analgesia

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