Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy

April 16, 2024 updated by: Hoda Mohamed, Future University in Egypt

Postoperative Pain Management Following Laparoscopic Cholecystectomy- Intraperitoneal Granisetron

Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. No. study has investigated IP granisetron as an adjuvant to standard care for postoperative pain management in patients undergoing LC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain is a main challenge for delayed hospital discharge in Laparoscopic cholecystectomy. . Postoperative pain management is essential and the inability to treat acute pain appropriately in the first 48 postoperative hours represents a risk factor for developing chronic pain. Granisetron is frequently used as a premedication to avoid postoperative nausea and vomiting in patients who have undergone general anesthesia. The purpose of this study is evaluating the efficacy and tolerability of preoperative oral administration of IP granisetron on postoperative pain control in patients undergoing LC

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11617
        • Recruiting
        • National Hepatology and Tropical Research Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who are scheduled to undergo elective LC.
  • Adults (males and/or females) between the ages of 18-70 years old.

Exclusion Criteria:

  • Chronic pain other than cholelithiasis.
  • Patients who received analgesics or sedatives 24 h before scheduled surgery.
  • Severe hepatic (Child Pugh Class B and C) and renal dysfunction (CrCl <30ml/min)
  • Previous allergic response to vortioxetine, and granisetron.
  • Pregnancy and lactation
  • Patients with communication problems, cognitive dysfunction, or psychological disorders
  • Daily corticosteroid use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control arm
2 ml IP normal saline (0.9 % NaCl)
Other: Normal saline
2 ml IP normal saline (0.9% NaCl)
Experimental: Intervention arm
2ml IP granisetron (1 mg/mL)
Drug: Granisetron 1 Mg/mL Intravenous Solution
2mL intraperitoneal adminstration of granisetron (1 mg/mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS score
Time Frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours
Pain intensity: VAS score
2 hours, 4 hours, 8 hours, 12 hours, 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to analgesic request
Time Frame: 24 hours
Time to first rescue analgesic request
24 hours
Quality of life (QoL) after laparoscopic cholecystectomy (LC)
Time Frame: 3 months
Gastrointestinal Quality of Life Index questionnaire for QOL assessment with calculation of the score; most desirable option: 4 points, least desirable option: 0 points and GIQLI score: sum of the point. GIQLI ranges from 0 to 80 with higher scores indicating a better quality of life.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

February 18, 2024

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5-24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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