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

NCT06288841 | Recruiting

• 1 other identifier: TJMZ2023-008
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• NRS pain score within 72 hours after surgery

  After surgery (starting from the end of surgery), NRS was evaluated at 2h, 4h, 6h, 8h, 12h, 24h, 48h, and 72h

  Postoperative (starting from the end of the operation) 2 hours (h), 4h, 6h, 8h, 12h, 24h, 48h, 72h

Study Arms (4)

Ropivacaine injection group

PLACEBO COMPARATOR

Drug: Ropivacaine injection

Bupivacaine liposomal low-dose group

EXPERIMENTAL

Drug: Bupivacaine liposome

Bupivacaine liposomal medium-dose group

EXPERIMENTAL

Drug: Bupivacaine liposome

Bupivacaine liposomal high-dose group

EXPERIMENTAL

Drug: Bupivacaine liposome

Interventions

Ropivacaine injection DRUG

Ultrasound-guided bilateral QLB2 was performed using Ropivacaine injection prior to anesthesia induction

Also known as: Quadratus lumborum block

Ropivacaine injection group

Bupivacaine liposome DRUG

Ultrasound-guided bilateral QLB2 was performed using Bupivacaine liposome injection prior to anesthesia induction

Also known as: Quadratus lumborum block

Bupivacaine liposomal high-dose group; Bupivacaine liposomal low-dose group; Bupivacaine liposomal medium-dose group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Age 18-65 years; 2) ASA grade I or II; 3) Patients who are scheduled to undergo elective laparoscopic hysterectomy or laparoscopic hysterectomy and double adnexectomy; 4) BMI of 19-29 kg/m2; 5) Patients who voluntarily sign the informed consent form.

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Ning Luo

CONTACT

13622098703; ningluo1996@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: November 30, 2023
• Primary Completion: July 31, 2024
• Study Completion: November 29, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)