Clinical trial NCT06430112: Liposomal Bupivacaine vs Ropivacaine for TAPBs
Official title: Liposomal Bupivacaine vs Ropivacaine for Ultrasound-guided Transversus Abdominis Plane Blocks in Laparoscopic Lower Abdominal Tumor Resection: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Abdominal Tumor
Postoperative Analgesia
Liposomal Bupivacaine
Ropivacaine
Keywords: liposomal bupivacaine
ropivacaine
transversus abdominis plane block
laparoscopic lower abdominal tumor resection
opioid consumption
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative opioid use
timeFrame: 3 days postoperatively
Secondary outcomes:
measure: Postoperative pain score
timeFrame: 3 days postoperatively
measure: Postoperative adverse reactions
timeFrame: 3 days postoperatively
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Jingdun Xie
state: Guangdong
Study officials:
affiliation: Department of Anesthesiology,Sun Yat-Sen University Cancer Center
name: Jingdun Xie
role: PRINCIPAL_INVESTIGATOR
References: