Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

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Brief Title

Ondansetron Effect on Pain Relief After Laparoscopic Cholecystectomy

Official Title

Efficacy of Intraperitoneal Ondansetron Administration on Pain Relief After Laparoscopic Cholecystectomy

Brief Summary

      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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

change in postoperative pain between the two groups using visual analogue score (VAS)

Condition

Cholecystitis

Intervention

Ondansetron

Study Arms / Comparison Groups

 Ondansetron
Description:  Ondansetron intraperitoneal in the gall bladder bed

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

50

Start Date

July 15, 2020

Completion Date

December 18, 2020

Primary Completion Date

December 18, 2020

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

Egypt

Location Countries

Egypt

Administrative Informations

NCT ID

NCT04468685

Organization ID

12-2020

Responsible Party

Principal Investigator

Study Sponsor

National Hepatology & Tropical Medicine Research Institute

Study Sponsor

, ,

Verification Date

January 2021