Efficacy of Liposomal Bupivacaine for Transversus Abdominis Plane Block

Tianjin First Central Hospital86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain Liposomal Bupivacaine

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 24 hours after surgery

Secondary Outcomes

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

Time frame: 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.

Time frame: 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）.

Time frame: 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.

Time frame: 72 hours after surgery

Gastrointestinal function recovery

Time to first flatus and time to first defecation, measured from the end of surgery.

Time frame: 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.

Time frame: 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.

Time frame: Postoperatively, through hospital discharge, and at follow-up (up to 7 days after surgery)