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Clinical Trials/NCT06430112
NCT06430112
Recruiting
Phase 3

Liposomal Bupivacaine vs Ropivacaine for Ultrasound-guided Transversus Abdominis Plane Blocks in Laparoscopic Lower Abdominal Tumor Resection: A Prospective Randomized Trial

Sun Yat-sen University1 site in 1 country74 target enrollmentNovember 1, 2023

Overview

Phase
Phase 3
Intervention
Liposomal Bupivacaine
Conditions
Abdominal Tumor
Sponsor
Sun Yat-sen University
Enrollment
74
Locations
1
Primary Endpoint
Postoperative opioid use
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Few studies have compared the efficacy of ultrasound (US)-guided TAP blocks with Liposomal bupivacaine(LB) versus ropivacaine in reducing postoperative opioid usage in patients undergoing laparoscopic lower abdominal tumor Resection. Therefore, we are conducting this prospective, randomized controlled trial to compare the postoperative analgesic effects of LB and ropivacaine for TAP blocks among patients undergoing laparoscopic colorectal procedures.

Detailed Description

This study aimed to investigate the impact of liposomal bupivacaine (LB) on postoperative opioid usage for ultrasound(US)-guided transversus abdominis plane (TAP) blocks in laparoscopic colorectal resections. We divided 76 patients into two groups. An injection of bilateral TAP blocks was administered to LB group using 133mg liposomal bupivacaine in each block (266mg total), and to R group using 20 ml 0.25% ropivacaine in each block (40 ml total). Opioid consumption and pain scores at 6h, 24h, 48h and 72h were recorded postoperatively, as well as the total intraoperative remifentanil dose, the hospital stay lengths after surgery, and adverse events including dizziness, nausea, and vomiting.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
June 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Ping Yu

Doctor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing laparoscopic resection of lower abdominal tumors
  • ASA grade II-III
  • Age: 18-70 years.

Exclusion Criteria

  • (1) The patient does not agree to participate in the clinical study
  • (2) The patient has a clear history of opioid tolerance or allergy
  • (3) The patient has a history of local anesthetic allergy
  • (4) Previous history of dementia, mental illness or other central nervous system diseases
  • (5) Have a history of chronic pain or are taking opioids and other analgesics
  • (6) Patients are generally in poor condition with a history of serious diseases of cardiovascular system, respiratory system, digestive system, urinary system or central nervous system, and may not survive for more than 3 months
  • (7) The patient had any of the following conditions in the 12 months before surgery: myocardial infarction, severe/unstable angina pectoris, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident, pulmonary embolism
  • (8) Pregnant women
  • (9) Unable to cooperate with follow-up or poor compliance
  • (10) Patients with acute myocardial infarction, cardiac arrest or shock during surgery or hospitalization

Arms & Interventions

Liposomal Bupivacaine group

Liposomal Bupivacaine was used in the group

Intervention: Liposomal Bupivacaine

Ropivacaine group

Ropivacaine was used in this group

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Postoperative opioid use

Time Frame: 3 days postoperatively

The amount of drug used in the postoperative analgesia pump

Secondary Outcomes

  • Postoperative adverse reactions(3 days postoperatively)
  • Postoperative pain score(3 days postoperatively)

Study Sites (1)

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