Liposomal Bupivacaine vs Ropivacaine for TAPBs

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Postoperative Analgesia; Abdominal Tumor; Ropivacaine; Liposomal Bupivacaine

Treatments: Drug: Ropivacaine; Drug: Liposomal Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06430112

B2023-485-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

Liposomal Bupivacaine group

Experimental group

Description:

Liposomal Bupivacaine was used in the group

Treatment:

Drug: Liposomal Bupivacaine

Ropivacaine group

Active Comparator group

Description:

Ropivacaine was used in this group

Treatment:

Drug: Ropivacaine