NCT06288841

Efficacy and Safety of Liposomal Bupivacaine Under ERAS Concept for Postoperative Analgesia of Ultrasound-Guided QLB in Gynecologic Laparoscopic Patients: A Randomized, Single-blind, Active-Controlled Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Tianjin Medical University General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

With the development of the concept of comfortable medicine and enhanced recovery surgery (ERAS), optimizing the perioperative management of patients, reducing surgical stress, and reducing postoperative pain can effectively reduce perioperative complications and achieve the purpose of accelerating recovery. As an important part of ERAS, multimodal analgesia is the core concept of perioperative analgesia management. As a kind of perioperative multimodal analgesia, quadratus lumbar muscle block (QLB) is a type of local anesthetic drug injected around the quadratus lumbar muscle to reduce or eliminate abdominal wall pain and visceral pain after abdominal surgery. QLB has been used successfully for pain control after laparoscopic and open surgery, reducing perioperative opioid use and improving prognosis-related measures such as PONV and length of hospital stay. Bupivacaine liposomes use DepoFoam technology to encapsulate the drug in polycystic liposomes, which can prolong the release time of bupivacaine due to the different rupture times of different vesicles, and the postoperative analgesia can be up to 72 hours. In this project, patients who undergo elective laparoscopic uterine and double adnexectomy were selected to be injected with lipososomes of bupivacaine at different concentrations under ultrasound guidance of bilateral posterior QLB before anesthesia induction, and the effect of liposomal bupivacaine on postoperative pain was investigated by evaluating the postoperative pain and incidence of adverse events. This study will greatly promote the clinical promotion and application of bupivacaine liposome, improve the postoperative comfort and satisfaction of patients, and accelerate the postoperative recovery of patients.

Conditions

• Pharmacological Action

Interventions

Type	Name	Description
DRUG	Ropivacaine injection	Ultrasound-guided bilateral QLB2 was performed using Ropivacaine injection prior to anesthesia induction
DRUG	Bupivacaine liposome	Ultrasound-guided bilateral QLB2 was performed using Bupivacaine liposome injection prior to anesthesia induction

Timeline

• Start date: 2023-11-30
• Primary completion: 2024-07-31
• Completion: 2024-11-29
• First posted: 2024-03-01
• Last updated: 2024-03-01

Locations

1 site across 1 country: China