Efficacy of Liposomal Bupivacaine for Transversus Abdominis Plane Block

Liposomal Bupivacaine Versus Ropivacaine for Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Randomized, Single-Blind, Parallel-Group Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Liposomal Bupivacaine
• Intervention / Treatment: Drug: Liposomal Bupivacaine TAP block; Drug: Ropivacaine TAP blocks

• Study Type: Interventional
• Enrollment (Estimated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ke yu Zhang; Phone Number: +86 19861121816; Email: m456365zky@163.com
• Study Contact Backup: Name: Lili Jia; Phone Number: +86 13102058301; Email: jialili19880801@163.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300384
      • Recruiting
      • Tianjin First Central Hospital
      • Contact: Lili Jia; Phone Number: +86 13102058301; Email: jialili19880801@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal Bupivacaine Group; Patients in this group will receive transversus abdominis plane (TAP) block with liposomal bupivacaine after surgery.	Drug: Liposomal Bupivacaine TAP block; Liposomal bupivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.
Active Comparator: Ropivacaine group; Patients in this group will receive transversus abdominis plane (TAP) block with Ropivacaine after surgery.	Drug: Ropivacaine TAP blocks; Standard-dose ropivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative NRS pain scores at different time points	NRS scores at 24, 48, and 72 hours post-surgery while at rest; NRS scores at 48 and 72 hours while active	24, 48, and 72 hours after surgery
Postoperative recovery quality (QoR-15 scale)	Postoperative recovery quality will be evaluated using the 15-item Quality of Recovery (QoR-15) scale at 24 hours after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery quality.	24, 48, and 72 hours after surgery
Time to first rescue analgesia	The time from the end of surgery to the first request for rescue analgesia (e.g., opioid or non-opioid analgesics) will be recorded（background pain is excluded）.	Up to 72 hours after surgery
Total postoperative analgesic consumption within 72 hours	Total amount of rescue analgesics (e.g., opioids, NSAIDs) used by each patient within 72 hours after surgery will be calculated and converted into equivalent doses.	72 hours after surgery
Gastrointestinal function recovery	Time to first flatus and time to first defecation, measured from the end of surgery.	Postoperatively, through hospital discharge, up to 7 days after surgery
Postoperative length of hospital stay	The total number of days from surgery to hospital discharge will be recorded.	Postoperatively, through hospital discharge (up to 7 days)
Incidence of adverse events	Adverse events including nausea, vomiting, dizziness, local anesthetic toxicity, and neurological complications will be recorded and compared between groups during hospitalization and follow-up.	Postoperatively, through hospital discharge, and at follow-up (up to 7 days after surgery)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of chronic post-surgical pain (CPSP) at 3 months	The incidence of chronic post-surgical pain will be assessed via telephone follow-up.Incidence of chronic post-surgical pain (CPSP) , defined as persistent pain (NRS ≥ 1) at the surgical site lasting ≥ 3 months after laparoscopic cholecystectomy, excluding pain caused by other etiologies.	3 months after surgery

Collaborators and Investigators

• Sponsor: Tianjin First Central Hospital
• Investigators: Study Director: Wenli Yu, Tianjin First Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: April 21, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Pain; Liposomal Bupivacaine; Transverse Abdominal Plane Block; Anesthetic Recovery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: KYAP2025-52

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) will be made available upon reasonable request to the corresponding author, beginning 12 months after the publication of the primary results manuscript.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No