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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:

• 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;

• Patients must be able to understand the nature and potential personal consequences of the clinical trial, signing of the informed consent form.

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
Contact Information
Primary
Fang Luo
13611326978@163.com
+86 13611326978
Time Frame
Start Date: 2026-03-02
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 156
Treatments
Active_comparator: Bupivacaine hydrochloride group
Experimental: Liposomal Bupivacaine plus Bupivacaine hydrochloride group
Related Therapeutic Areas
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov

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