Long-acting liposomal bupivacaine for pain after hemorrhoid surgery

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

This test tries whether injecting long-acting liposomal bupivacaine around the surgical site reduces postoperative pain for adults having elective hemorrhoid surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 156 (estimated)
• Ages: 18 Years to 64 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07442539 on ClinicalTrials.gov

What this trial studies

This interventional study compares local infiltration with standard bupivacaine versus liposomal bupivacaine combined with bupivacaine in adults undergoing elective hemorrhoid surgery under general anesthesia. The liposomal formulation is an extended-release local anesthetic designed to provide analgesia for up to 72 hours after a single injection. Participants receive the assigned local injection at the time of surgery and are monitored for postoperative pain, use of additional analgesics, and safety outcomes. The trial is conducted at Beijing Tiantan Hospital and follows patients through the immediate postoperative period.

Who should consider this trial

Good fit: Adults aged 18–64 scheduled for elective hemorrhoid surgery under general anesthesia with ASA physical status I–III and the capacity to give informed consent are ideal candidates.

Not a fit: Patients with chronic pain syndromes, cardiac conduction blocks or unstable coronary disease, active gastrointestinal bleeding or ulcers, insulin-treated diabetes, coagulation dysfunction, or those taking anticoagulants may not benefit or are excluded.

Why it matters

Potential benefit: If successful, this approach could provide longer-lasting pain relief after hemorrhoid surgery and reduce the need for additional opioids or rescue analgesics.

How similar studies have performed: Liposomal bupivacaine has been used in other surgical settings with mixed but sometimes positive results for prolonged analgesia, while its specific benefit for hemorrhoid surgery is less well established.

Eligibility criteria

Inclusion Criteria:

1. Patients scheduled for elective Hemorrhoid Surgery 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 Hemorrhoid Surgery; Liposome Bupivacaine; Pain Management; Local Infiltration