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

Pharmacological Action Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06288841
• Other study ID #: TJMZ2023-008
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: November 29, 2024

Study information

• Verified date: February 2024
• Source: Tianjin Medical University General Hospital
• Contact: Ning Luo
• Phone: 13622098703
• Email: ningluo1996[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 29, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacological Action

Intervention

Drug:
• Ropivacaine injection
Ultrasound-guided bilateral QLB2 was performed using Ropivacaine injection prior to anesthesia induction
• Bupivacaine liposome
Ultrasound-guided bilateral QLB2 was performed using Bupivacaine liposome injection prior to anesthesia induction

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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