The Efficacy and Safety of Liposomal Bupivacaine for Transversus Abdominis Plane Block in Relieving Postoperative Pain After Laparoscopic Surgery

Summary

Laparoscopic surgery has become the preferred approach for abdominal surgical interventions due to its advantages of minimal invasiveness, rapid recovery, and reduced complication rates. Despite its minimally invasive nature, postoperative pain persists and adversely affects patient recovery. In the absence of effective pain management, acute pain may progress to chronic pain. Although opioids provide reliable analgesic effects, their associated adverse reactions limit their application following minimally invasive procedures. Regional analgesia serves as the cornerstone of multimodal analgesia, and ultrasound-guided nerve block techniques have become increasingly refined. Ultrasound-guided transversus abdominis plane block(TAPB) generally fulfills intraoperative and postoperative analgesic requirements for laparoscopic surgeries by inhibiting the transmission of nociceptive stimuli in the targeted region, thereby aiding in the prevention of central sensitization. Conventional TAPB utilize local anesthetics, which demonstrate excellent efficacy in alleviating incisional pain. However, the short duration of analgesia provided by conventional local anesthetics significantly compromises their clinical utility.Liposomal bupivacaine(LB) is a novel, long-acting, sustained-release amide-type local anesthetic, providing localized analgesic effects for up to 72 hours.However, its efficacy and safety in laparoscopic surgery not yet been fully validated. Based on this premise, the present study aims to evaluate and compare the clinical outcomes of Ultrasound-guided TAPB utilizing liposomal bupivacaine plus bupivacaine for postoperative pain management in patients undergoing laparoscopic surgery.

Conditions

• Laparoscopic Surgery
• Liposomal Bupivacaine
• Transversus Abdominis Plane Block

Interventions

DRUG

Bupivacaine hydrochloride

Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A bilateral transverse abdominis plane block(TAPB) will be performed using a 22-gauge block needle, with 20 mL of 0.25% bupivacaine administered per side. The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen(containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.

DRUG

Liposomal bupivacaine plus bupivacaine

Prior to surgical incision, the Doppler ultrasound-guided injection technique will be employed. A bilateral transverse abdominis plane block(TAPB) will be performed using a 22-gauge block needle, 20 mL (266 mg) of liposomal bupivacaine will be mixed with 20 mL of 0.25% bupivacaine hydrochloride (50 mg, diluted in normal saline) to prepare a 40 mL solution. A volume of 20 mL will be administered to each side.The patient-controlled analgesia (PCA) pump solution consists of 100 μg sufentanil and 16 mg ondansetron diluted with normal saline to a total volume of 100 mL. Postoperatively, patients may self-administer a 2-mL bolus per demand, with a lockout interval of 10 minutes. Should analgesia remain inadequate after four consecutive boluses, one tablet of oxycodone-acetaminophen may be administered orally, with a minimum repeat dosing interval of 6 hours. For persistent pain, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.

Sponsors & Collaborators

• Beijing Tiantan Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-10

Primary Completion

2027-03-30

Completion

2027-06-30

Countries

• China

Study Locations