Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

National Hepatology & Tropical Medicine Research Institute

Status and phase: Completed; Phase 2

Conditions: Cholecystitis

Treatments: Drug: Normal saline; Drug: Ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT04468685

12-2020 (Other Identifier)

Details and patient eligibility

About

Laparoscopic cholecystectomy (LC) is an easy procedure characterized by its minimal invasiveness, less post-operative pain and early recovery when compared to the open conventional cholecystectomy. However, patients who have undergone LC still complain of postoperative pain. It has been reported that ondansetron produces numbness when injected under the skin and has local anesthetic effect that is 15 times more potent than lidocaine the most widely used local anesthetic and probably explains its antiemetic action. It possesses anti-inflammatory, anesthetic, and analgesic properties by its multifaceted actions as a 5-HT3 receptor antagonist, a Na channel blocker, and a mu-opioid agonist which may have a potential role in decreasing pain. The study aimed to demonstrate the effectiveness of IP administration of ondansetron on pain management post LC.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are scheduled to undergo elective LC

Exclusion criteria

• Patients undergoing chronic pain treatment
• Previous allergic response to local anesthetics or 5-HT3 receptor antagonists
• Patients who received analgesics or sedatives 24 h before scheduled surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Ondansetron

Experimental group

Description:

Ondansetron intraperitoneal in the gall bladder bed

Treatment:

Drug: Ondansetron

Saline

Placebo Comparator group

Description:

Normal saline intraperitoneal in the gall bladder bed

Treatment:

Drug: Normal saline