Thoracic Surgery Intercostal Block Trial With Liposomal vs. Hydrochloride Bupivacaine

NCT07134660 | Recruiting DMC

• 1 other identifier: 2024LY0971
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain, Acute; Lung Cancer

Keywords

Postoperative Pain; Intercostal Nerve Block; Liposomal Bupivacaine

Outcome Measures

Primary Outcomes (1)

• Pain score area under the curve (AUC) from 25 to 72 hours postoperatively

  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).

  25 to 72 hours after the end of surgery

Secondary Outcomes (2)

• Pain score at PACU discharge and postoperative intervals

  At PACU discharge, and 6, 12, 24, 48, and 72 hours postoperatively

• Cumulative opioid consumption

  From the end of surgery to 48 hours after surgery

Other Outcomes (5)

• Duration of chest wall analgesia

  From intervention (end of surgery) up to 7 days

• Quality of Recovery (QoR-15) score

  24, 48, and 72 hours after surgery

• Incidence of postoperative nausea and vomiting

  24, 48, and 72 hours postoperatively

Study Arms (3)

Liposomal Bupivacaine Group

EXPERIMENTAL

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

Procedure: Liposomal Bupivacaine intercostal nerve block

Bupivacaine Hydrochloride Group

ACTIVE COMPARATOR

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

Procedure: Bupivacaine Hydrochloride intercostal nerve block

Control Group (Standard Analgesia Only)

SHAM COMPARATOR

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.

Other: Standard Postoperative Analgesia

Interventions

Liposomal Bupivacaine intercostal nerve block 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.

Liposomal Bupivacaine Group

Standard Postoperative Analgesia OTHER

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

Control Group (Standard Analgesia Only)

Bupivacaine Hydrochloride intercostal nerve block 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.

Bupivacaine Hydrochloride Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai pulmonary hospital

Shanghai, China

RECRUITING

Related Publications (2)

• Huang J, Wang L, Wei S, Xin Y, Chang R, Liu H, Yang Y, Song J, Lv X. Comparison of liposomal bupivacaine and bupivacaine hydrochloride intercostal nerve blocks for postoperative analgesia after thoracic surgery: a multicenter, randomized, three arms trial protocol. Ann Med. 2026 Dec;58(1):2612384. doi: 10.1080/07853890.2025.2612384. Epub 2026 Jan 20.

  PMID: 41560407 DERIVED

• Yu J, Wei S, Ling D, Xin Y, Liu H, Yang Y, Li X, Xiang Z, Liu J. Effective Dose of Oliceridine for Inhibiting Hemodynamic Elevation Induced by Tracheal Intubation: An Up-and-Down Sequential Trial. Drug Des Devel Ther. 2025 Dec 26;19:11767-11778. doi: 10.2147/DDDT.S567868. eCollection 2025.

  PMID: 41477178 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Lung Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xin Y Lv, PhD

  Shanghai Pulmonary Hospital, Tongji University, Shanghai, China

  STUDY DIRECTOR

Central Study Contacts

Shiyou Wei, PhD

CONTACT

8615601680288; lovewishyou@163.com

Xin Lv, PhD

CONTACT

8618852869700; xinlvg@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All patients underwent the intervention at the end of the surgery and before regaining consciousness from anesthesia, meaning that the patients were unconscious at this time.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)