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

Summary

Laparoscopic surgery, characterized by minimal invasiveness, rapid recovery, and shorter hospital stays, has been widely adopted in Gynecologic Oncology. However, the elevation and stretching of the diaphragm following pneumoperitoneum, combined with increased intra-abdominal pressure compressing visceral organs and causing ischemia-hypoxia, can trigger systemic inflammatory responses and lead to postoperLaparoscopic surgery, characterized by minimal invasiveness, rapid recovery, and shorter hospital stays, has been widely adopted in gynecological procedures. However, the elevation and stretching of the diaphragm following pneumoperitoneum, combined with increased intra-abdominal pressure compressing visceral organs and causing ischemia-hypoxia, can trigger systemic inflammatory responses and lead to postoperative pain. Inadequate or delayed pain management may prolong hospitalization, and some patients may develop chronic pain, resulting in altered behavioral patterns. As one of the analgesic strategies after abdominal surgery, transversus abdominis plane block (TAPB) not only reduces opioid consumption and the incidence of complications but also avoids adverse effects associated with epidural analgesia. Nevertheless, the analgesic duration provided by a single-injection TAPB is limited, while continuous TAPB faces constraints in clinical application due to challenges such as catheter fixation.Inadequate or delayed pain management may prolong hospitalization, and some patients may develop chronic pain, resulting in altered behavioral patterns. As one of the analgesic strategies after abdominal surgery, TAPB not only reduces opioid consumption and the incidence of complications but also avoids adverse effects associated with epidural analgesia. Nevertheless, the analgesic duration provided by a single-injection TAPB is limited, while continuous TAPB faces constraints in clinical application due to challenges such as catheter fixation. 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 in Gynecologic Oncology.

Conditions

• Laparoscopic Surgery
• Gynecologic Oncology Patient
• 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