Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT07442539

The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Hemorrhoid Surgery

Led by Beijing Tiantan Hospital · Updated on 2026-03-06

156

Participants Needed

1

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Hemorrhoids represents the most prevalent condition among anorectal disorders. Due to the unique anatomical characteristics of the perianal region, patients frequently experience severe postoperative pain, which may lead some individuals to delay treatment due to pain-related anxiety. Consequently, effective postoperative pain management is critical for the recovery of hemorrhoid patients. Developing a simplified, efficient, and safe analgesic approach to alleviate postoperative pain has become an urgent issue in perioperative care. Multimodal analgesia regimens recommend the combined use of local anesthetics to synergistically reduce perioperative pain intensity. However, the primary limitation of this analgesic modality lies in the relatively short duration of action following a single injection of local anesthetic.Liposomal bupivacaine is an innovative long-acting, extended-release amide-type local anesthetic that provides analgesic efficacy for up to 72 hours. However, its efficacy and safety for local infiltration analgesia following hemorrhoid surgery have not been fully validated. Against this backdrop, the present study aims to evaluate and compare the clinical outcomes and safety profile of liposomal bupivacaine versus conventional bupivacaine for postoperative pain management via local infiltration in patients undergoing Hemorrhoid surgery.

CONDITIONS

Official Title

The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative Pain After Hemorrhoid Surgery

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for elective Hemorrhoid Surgery under general anesthesia
  • Ages 18 to 64 years old
  • American Society of Anesthesiologists (ASA) physical status of I-III
  • Glasgow Coma Scale (GCS) score of 15
  • Ability to understand the trial and provide informed consent
Not Eligible

You will not qualify if you...

  • History of chronic pain syndrome of any cause
  • Heart conduction block (sinus block or atrioventricular block)
  • Unstable coronary artery disease
  • Gastric ulcer or gastric bleeding
  • Diabetes treated with insulin
  • Coagulation dysfunction or use of oral anticoagulants not stopped before surgery
  • Abnormal liver function with ALT and/or AST > 2 times upper limit of normal or total bilirubin ≥ 1.5 times upper limit
  • Renal impairment with serum creatinine > 176 µmol/L or dialysis within 28 days before surgery
  • History of diagnosed mental illness or current use of psychotropic medication
  • Excessive alcohol or drug abuse, chronic opioid use, recent use of sedatives or analgesics, or painkiller use within 24 hours before surgery
  • Pregnancy or breastfeeding
  • Extreme body mass index (BMI) less than 15 or greater than 35
  • Participation in another interventional trial affecting this study
  • History of allergy to local anesthetics or study drugs

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

F

Fang Luo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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