Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine

NCT ID: NCT07134660

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2025-12-20

Brief 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.

Detailed Description

Background: Lung cancer surgery, even with minimally invasive thoracoscopy, causes significant postoperative pain in up to 62.9% of patients, potentially leading to complications and chronic pain. Intercostal nerve block is a safe alternative to epidural analgesia, but standard local anesthetics like bupivacaine provide limited duration (<8 hours). Liposomal bupivacaineoffers prolonged release up to 72 hours.

Objective: To compare the analgesic efficacy of liposomal bupivacaine versus bupivacaine hydrochloride in intercostal nerve block, assessing pain scores, opioid use, recovery quality, and complications in thoracoscopic lung surgery patients.

Design: Multicenter, randomized controlled trial with 210 participants (70 per group). Randomization with (1:1:1).

Methods: Eligible patients receive ultrasound-guided intercostal block post-surgery: Liposomal bupivacaine (20 mL, 266 mg), bupivacaine HCl (20 mL, 0.25%), or control (IV PCA only). Follow-up includes pain scores, opioid consumption, QoR-15, and adverse events up to 72 hours.

Expected Outcomes: Liposomal bupivacaine expected to reduce pain AUC by >10% vs. bupivacaine and >15% vs. control from 25-72 hours.

Conditions

Postoperative Pain, Acute; Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Liposomal Bupivacaine Group

Ultrasound-guided intercostal nerve block performed at the end of surgery before emergence from anesthesia using liposomal bupivacaine 266 mg (20 mL). Patients also receive standard postoperative analgesia with IV PCA (patient-controlled analgesia) opioids and regular acetaminophen

Group Type: EXPERIMENTAL

Liposomal Bupivacaine intercostal nerve block

Intervention Type: PROCEDURE

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 Group

Ultrasound-guided intercostal nerve block performed at the end of surgery before emergence from anesthesia using 0.25% bupivacaine hydrochloride (20 mL). Patients also receive standard postoperative analgesia with IV PCA opioids and regular acetaminophen

Group Type: ACTIVE_COMPARATOR

Bupivacaine Hydrochloride intercostal nerve block

Intervention Type: PROCEDURE

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.

Control Group (Standard Analgesia Only)

No intercostal nerve block, just wait same time. Patients receive standard postoperative analgesia consisting of IV PCA opioids and regular acetaminophen, beginning immediately after surgery.

Group Type: SHAM_COMPARATOR

Standard Postoperative Analgesia

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Standard Postoperative Analgesia

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

Shiyou Wei

Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Y Lv, PhD

Role: STUDY_DIRECTOR

Shanghai Pulmonary Hospital, Tongji University, Shanghai, China

Central Contacts

Shiyou Wei, PhD

Role: CONTACT

lovewishyou@163.com

8615601680288

Xin Lv, PhD

Role: CONTACT

xinlvg@126.com

8618852869700

Other Identifiers

2024LY0971

Identifier Type: -

Identifier Source: org_study_id