Efficacy of Liposomal Bupivacaine for Transversus Abdominis Plane Block

NCT07577934 | Recruiting

• 1 other identifier: KYAP2025-52
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, randomized, single-blind, parallel-group clinical trial. The study aims to compare the analgesic efficacy of liposomal bupivacaine versus ropivacaine for transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. Eligible participants will be randomly assigned to receive either liposomal bupivacaine or ropivacaine for TAP block during surgery. The primary outcome is the dynamic NRS pain score at 24 hours after surgery. Secondary outcomes include static and dynamic NRS pain scores at multiple time points, QoR-15 recovery quality, time to first rescue analgesia, analgesic consumption, gastrointestinal function recovery, length of hospital stay, and adverse events. Participants will be followed up to 3 months after surgery to evaluate the incidence of chronic post-surgical pain (CPSP). All participants will receive routine clinical care, and participation is voluntary.

Conditions

Postoperative Pain; Liposomal Bupivacaine

Keywords

Liposomal Bupivacaine; Postoperative Pain; Transverse Abdominal Plane Block; Anesthetic Recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative dynamic NRS pain score at 24 hours

  Postoperative pain intensity under dynamic conditions (e.g., coughing or deep breathing) will be assessed using the Numerical Rating Scale (NRS, 0-10, where 0 = no pain and 10 = worst imaginable pain).

  24 hours after surgery

Secondary Outcomes (7)

• Postoperative NRS pain scores at different time points

  24, 48, and 72 hours after surgery

• Postoperative recovery quality (QoR-15 scale)

  24, 48, and 72 hours after surgery

• Time to first rescue analgesia

  Up to 72 hours after surgery

• Total postoperative analgesic consumption within 72 hours

  72 hours after surgery

• Gastrointestinal function recovery

  Postoperatively, through hospital discharge, up to 7 days after surgery

Other Outcomes (1)

• Incidence of chronic post-surgical pain (CPSP) at 3 months

  3 months after surgery

Study Arms (2)

Liposomal Bupivacaine Group

EXPERIMENTAL

Patients in this group will receive transversus abdominis plane (TAP) block with liposomal bupivacaine after surgery.

Drug: Liposomal Bupivacaine TAP block

Ropivacaine group

ACTIVE COMPARATOR

Patients in this group will receive transversus abdominis plane (TAP) block with Ropivacaine after surgery.

Drug: Ropivacaine TAP blocks

Interventions

Liposomal Bupivacaine TAP block DRUG

Liposomal bupivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.

Liposomal Bupivacaine Group

Ropivacaine TAP blocks DRUG

Standard-dose ropivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.

Ropivacaine 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:

• Age 18-65 years, either gender.
• Patients scheduled for elective laparoscopic cholecystectomy.
• ASA physical status I-III.
• Able to provide written informed consent and complete the 3-month follow-up.

You may not qualify if:

• History of allergy to local anesthetics.
• History of dementia, psychosis, or other central nervous system diseases.
• History of chronic pain or long-term use of opioids or other analgesics.
• Contraindications to nerve block: infection at puncture site, severe coagulopathy.
• Severe hepatic or renal dysfunction, pregnancy, or lactation.

Sponsors & Collaborators

• Tianjin First Central Hospital: lead

Study Sites (1)

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300384, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Wenli Yu

  Tianjin First Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Ke yu Zhang

CONTACT

+86 19861121816; m456365zky@163.com

Lili Jia

CONTACT

+86 13102058301; jialili19880801@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a single-blind trial with blinded outcome assessment. The patients, outcome assessors, and statistical analysts are blinded to the group allocation. Only the anesthesiologist performing the transversus abdominis plane (TAP) block is aware of the treatment assignment, to ensure the safety and standardization of the procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 11, 2026
• Study Start: May 10, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)