Liposomal Bupivacaine vs Ropivacaine for TAPBs

Postoperative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06430112
• Other study ID #: B2023-485-01
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Sun Yat-sen University
• Contact: Ping Yu
• Phone: 00-86-13631373286
• Email: yuping[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: June 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Abdominal Tumor
• Liposomal Bupivacaine
• Postoperative Analgesia
• Ropivacaine

Intervention

Drug:
• Liposomal Bupivacaine
After induction of anesthesia, bilateral TAPB was performed under ultrasound guidance. The patients in the bupivacaine liposome group were injected with bupivacaine liposome 133mg(10ml+ 10ml 0.9% normal saline mixed into 20ml)/ point (two points in total).
• Ropivacaine
Patients in ropivacaine group were given 0.25% ropivacaine 20ml/ point (two points in total).

Locations

Country	Name	City	State
China	Jingdun Xie	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid use	The amount of drug used in the postoperative analgesia pump	3 days postoperatively
Secondary	Postoperative pain score	Postoperative VAS score	3 days postoperatively
Secondary	Postoperative adverse reactions	Postoperative adverse reactions were followed up	3 days postoperatively