Liposomal Bupivacaine vs Ropivacaine for TAPBs

Phase 3

Recruiting

• Conditions: Ropivacaine; Postoperative Analgesia; Liposomal Bupivacaine; Abdominal Tumor
• Interventions: Drug: Liposomal Bupivacaine; Drug: Ropivacaine

• Registration Number: NCT06430112
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2024-05
• Primary Completion: 2024-05-20
• Study First Submitted: 2024-05-21
• Study First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Study First Posted: 2024-05-28
• Last Update Posted: 2024-05-28
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

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

Exclusion Criteria

1. (1) The patient does not agree to participate in the clinical study
2. (2) The patient has a clear history of opioid tolerance or allergy
3. (3) The patient has a history of local anesthetic allergy
4. (4) Previous history of dementia, mental illness or other central nervous system diseases
5. (5) Have a history of chronic pain or are taking opioids and other analgesics
6. (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. (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. (8) Pregnant women
9. (9) Unable to cooperate with follow-up or poor compliance
10. (10) Patients with acute myocardial infarction, cardiac arrest or shock during surgery or hospitalization
11. (11) ASA score above grade III.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine group	Liposomal Bupivacaine	Liposomal Bupivacaine was used in the group
Ropivacaine group	Ropivacaine	Ropivacaine was used in this group

Primary Outcome Measures

Name	Time	Method
Postoperative opioid use	3 days postoperatively	The amount of drug used in the postoperative analgesia pump

Secondary Outcome Measures

Name	Time	Method
Postoperative adverse reactions	3 days postoperatively	Postoperative adverse reactions were followed up
Postoperative pain score	3 days postoperatively	Postoperative VAS score

Trial Locations

Locations (1)

Jingdun Xie; 🇨🇳 Guangzhou, Guangdong, China