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

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.

Study Overview

• Status: Recruiting
• Conditions: Pharmacological Action
• Intervention / Treatment: Drug: Ropivacaine injection; Drug: Bupivacaine liposome

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ning Luo; Phone Number: 13622098703; Email: ningluo1996@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • Recruiting
      • Tianjin Medical University General Hospital
      • Contact: Ning Luo; Phone Number: 13622098703; Email: ningluo1996@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1) 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.

Exclusion Criteria:

• 1) Those who are known to be allergic to the drug components of this study and have allergic constitution; 2) History of allergy to general anesthetic drugs, opioids, and non-steroidal drugs; 3) Patients who need to switch to laparotomy for various reasons; 4) history of neurological disease; History of chronic pain; drug addiction and alcohol abuse; History of long-term opioid use; Opioids are given 48 hours before surgery; 5) ASA grade III or IV; 6) Coronary heart disease, bronchial asthma, severe hypertension, severe hematologic dysfunction, liver and kidney function, and obvious abnormalities in electrolytes; 7) Patients with severe gastrointestinal diseases; 8) Patients who refuse to use intravenous PCIA for analgesia; 9) Pregnant or lactating women; 10) Patients with infection in the skin of the abdominal injection area; 11) Patients with rheumatoid or inflammatory arthritis or diseases requiring chronic analgesic treatment; 12) Patients who have been treated for deep vein thrombosis, pulmonary embolism, myocardial infarction or ischemic stroke in the past 6 months; 13) Those who have poor compliance and cannot complete the test according to the research protocol; 14) Those who have participated in clinical trials of other drugs in the past 4 weeks; 15) Any circumstances that, in the opinion of the investigators, are not suitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Ropivacaine injection group	Drug: Ropivacaine injection; Ultrasound-guided bilateral QLB2 was performed using Ropivacaine injection prior to anesthesia induction; Other Names: Quadratus lumborum block
Experimental: Bupivacaine liposomal low-dose group	Drug: Bupivacaine liposome; Ultrasound-guided bilateral QLB2 was performed using Bupivacaine liposome injection prior to anesthesia induction; Other Names: Quadratus lumborum block
Experimental: Bupivacaine liposomal medium-dose group	Drug: Bupivacaine liposome; Ultrasound-guided bilateral QLB2 was performed using Bupivacaine liposome injection prior to anesthesia induction; Other Names: Quadratus lumborum block
Experimental: Bupivacaine liposomal high-dose group	Drug: Bupivacaine liposome; Ultrasound-guided bilateral QLB2 was performed using Bupivacaine liposome injection prior to anesthesia induction; Other Names: Quadratus lumborum block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tianjin Medical University General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): November 29, 2024

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: TJMZ2023-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No