Liposomal bupivacaine for pain after laparoscopic surgery

The Efficacy and Safety of Liposomal Bupivacaine Plus Bupivacaine Local Incisional Infiltration for Postoperative Pain in Patients Undergoing Laparoscopic Surgery:A Multi-Center Randomized Controlled Trial

This trial will test whether a long-acting, liposomal form of bupivacaine given at the incision reduces postoperative pain and the need for oral pain medicines in adults having elective laparoscopic procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07458256 on ClinicalTrials.gov

What this trial studies

This interventional study compares local infiltration with standard bupivacaine versus a liposomal bupivacaine formulation (with bupivacaine) at the surgical incision in adults undergoing elective laparoscopic cholecystectomy, hernia repair, or appendectomy. Participants meeting inclusion criteria receive one of the study injections at the wound site during surgery and are followed through the early postoperative period for pain intensity and analgesic use. Primary measurements focus on incision pain over the first 48–72 hours and supplemental oral opioid/analgesic consumption. Safety and adverse events related to local anesthetic use are also monitored.

Who should consider this trial

Good fit: Adults 18–64 years old with ASA physical status I–III scheduled for elective laparoscopic cholecystectomy, hernia repair, or appendectomy who can give informed consent.

Not a fit: Patients with chronic pain syndromes, certain heart conduction blocks, unstable coronary disease, active gastric bleeding, insulin-treated diabetes, coagulation dysfunction, or ongoing anticoagulant use are excluded and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could provide longer-lasting incision pain relief after laparoscopic surgery and reduce the need for oral opioids, helping patients recover faster.

How similar studies have performed: Other studies of liposomal bupivacaine in various surgical settings have sometimes shown reduced pain and opioid use, but results are mixed and evidence specifically for laparoscopic procedures is limited.

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; Local Infiltration