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: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Contact Information
Primary
Ning Luo
ningluo1996@163.com
13622098703
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2024-11-29
Participants
Target number of participants: 200
Treatments
Placebo_comparator: Ropivacaine injection group
Experimental: Bupivacaine liposomal low-dose group
Experimental: Bupivacaine liposomal medium-dose group
Experimental: Bupivacaine liposomal high-dose group
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University General Hospital

This content was sourced from clinicaltrials.gov

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