NCT07442539

The Efficacy and Safety of Liposomal Bupivacaine in Relieving Postoperative 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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemorrhoid Surgery
• Liposome Bupivacaine
• Pain Management
• Local Infiltration

Interventions

Type	Name	Description
DRUG	Bupivacaine hydrochloride	30 mL of 0.25% bupivacaine (75 mg, diluted in normal saline) was administered as a perianal infiltration at the conclusion of the surgical procedure. Using a 22-gauge needle, the solution was injected in a fan-shaped pattern into the perianal tissues.The PCA solution is prepared by diluting 100 μg of sufentanil and 16 mg of ondansetron with normal saline to a total volume of 100 mL. Postoperatively, the patient may press the demand button for analgesia. Each activation delivers a 2 mL bolus, with a lockout interval of 10 minutes.If analgesia remains inadequate after four consecutive demands, one Oxycodone and Acetaminophen Tablets (containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) is administered orally, with a minimum interval of 6 hours between repeated administrations. If pain persists, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.
DRUG	Liposomal bupivacaine plus bupivacaine	At the conclusion of the surgical procedure, perianal infiltration was administered with 30 mL of local anesthetic. Using a 22-gauge needle, the solution was injected in a fan-shaped.The local anesthetic is prepared by mixing 20 mL (266 mg) of liposomal bupivacaine with 20 mL of 0.25% bupivacaine and extracting a volume of 30 mL.The PCA solution is prepared by diluting 100 μg of sufentanil and 16 mg of ondansetron with normal saline to a total volume of 100 mL. Postoperatively, the patient may press the demand button for analgesia. Each activation delivers a 2 mL bolus, with a lockout interval of 10 minutes.If analgesia remains inadequate after four consecutive demands, one Oxycodone and Acetaminophen Tablets (containing 5 mg oxycodone hydrochloride and 325 mg acetaminophen) is administered orally, with a minimum interval of 6 hours between repeated administrations. If pain persists, intravenous morphine 5 mg may be administered at intervals no shorter than 4 hours.

Timeline

• Start date: 2026-03-02
• Primary completion: 2027-03-30
• Completion: 2027-06-30
• First posted: 2026-03-02
• Last updated: 2026-03-06

Locations

1 site across 1 country: China