Liposomal bupivacaine for pain after laparoscopic surgery
Official title: 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
Run by Beijing Tiantan Hospital · NCT07458256 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 64 Years |
| Sex | All |
| Enrollment | 190 (estimated) |
| Sponsor | Beijing Tiantan Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | March 10, 2026 |
| Main results expected | March 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT07458256 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Fang Luo
- Email: 13611326978@163.com
- Phone: +86 13611326978
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial tests whether liposomal bupivacaine with plain bupivacaine can better control postoperative pain after distal radial fracture surgery in patients at high risk of severe pain, compared with dexamethasone plus plain bupivacaine.
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Pre-incisional ropivacaine plus Diprospan for pain after laparoscopic surgery
This study tests whether injecting ropivacaine with Diprospan before surgery reduces pain after laparoscopic gallbladder, appendix, or hernia operations compared with ropivacaine alone.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.