Liposomal bupivacaine via transversus abdominis plane block to reduce pain after laparoscopic surgery

The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Transversus Abdominis Plane Block for Postoperative Pain in Patients Undergoing Laparoscopic Surgery:A Multi-Center Randomized Controlled Trial

This trial will test whether adding liposomal bupivacaine to an ultrasound-guided TAP block reduces postoperative pain and opioid use in adults having elective laparoscopic abdominal surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 318 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07458282 on ClinicalTrials.gov

What this trial studies

This single-center interventional trial at Beijing Tiantan Hospital compares standard bupivacaine TAP blocks with liposomal bupivacaine plus bupivacaine administered under ultrasound guidance in adults undergoing elective laparoscopic cholecystectomy, hernia repair, or appendectomy. Eligible participants are 18–64 years old with ASA physical status I–III and able to provide informed consent. The trial focuses on postoperative analgesia and safety, measuring pain scores, opioid consumption, and adverse events during the immediate postoperative period. Participants receive standardized general anesthesia and perioperative care while outcomes and complications are recorded.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–64 scheduled for elective laparoscopic cholecystectomy, hernia repair, or appendectomy under general anesthesia with ASA I–III and GCS 15 who can give informed consent.

Not a fit: Patients with chronic pain syndromes, cardiac conduction blocks, unstable coronary disease, active gastric bleeding or ulcers, insulin-treated diabetes, coagulation dysfunction, or those on anticoagulants that were not stopped before surgery are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could provide longer-lasting pain relief after laparoscopic procedures, reduce opioid requirements, and speed recovery.

How similar studies have performed: Previous studies of liposomal bupivacaine for regional blocks have shown mixed results, with some trials reporting longer analgesia and reduced opioid use while others found little or no advantage over standard bupivacaine.

Eligibility criteria

Inclusion Criteria:

1. Patients scheduled for elective laparoscopic cholecystectomy, hernia repair, and appendectomy under general anesthesia;
2. Ages 18 to 64 years old；
3. American Society of Anesthesiologists (ASA) physical status of I-III；
4. Glasgow Coma Scale (GCS) score of 15；
5. Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.

Exclusion Criteria:

1. History of chronic pain syndrome of any cause.
2. Patients with heart conduction block (sinus block or atrioventricular block).
3. Patients with unstable coronary artery disease.
4. Patients with gastric ulcer or gastric bleeding.
5. Patients with diabetes and are being treated with insulin.
6. Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran.
7. Patients with abnormal liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN.
8. Patients with renal impairment (serum creatinine \> 176 µmol/L) or receiving dialysis treatment within 28 days before surgery.
9. Patients with a history of diagnosed mental illness or currently taking psychotropic medication.
10. Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery.
11. Pregnancy or breastfeeding.
12. Extreme body mass index (BMI) (\< 15 or \> 35).
13. Participation in another interventional trial that interferes with the intervention or outcome of this trial.
14. Patients with a history of allergy to local anaesthetics or one of the study drugs.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Fang Luo

Conditions Laparoscopic Surgery; Liposomal Bupivacaine; Transversus Abdominis Plane Block