NCT06281418

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

February 29, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2024

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

9 months

First QC Date

February 18, 2024

Last Update Submit

January 9, 2025

Conditions

Post Operative Pain

Keywords

laparoscopicpost-operative painserotonin 5HT3 receptor antagonist

Outcome Measures

Primary Outcomes (1)

  • VAS score

    Pain intensity: VAS score

    2 hours, 4 hours, 8 hours, 12 hours, 24 hours

Secondary Outcomes (2)

  • Time to analgesic request

    24 hours

  • Quality of life (QoL) after laparoscopic cholecystectomy (LC)

    3 months

Study Arms (2)

Control arm

PLACEBO COMPARATOR

2 ml IP normal saline (0.9 % NaCl)

Other: Normal saline

Intervention arm

EXPERIMENTAL

2ml IP granisetron (1 mg/mL)

Drug: Granisetron 1 Mg/mL Intravenous Solution

Interventions

Granisetron 1 Mg/mL Intravenous SolutionDRUG

2mL intraperitoneal adminstration of granisetron (1 mg/mL)

Intervention arm
Normal salineOTHER

2 ml IP normal saline (0.9% NaCl)

Control arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 granisetron.
  • Pregnancy and lactation
  • Patients with communication problems, cognitive dysfunction, or psychological disorders
  • Daily corticosteroid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Hepatology and Tropical Research Institute

Cairo, 11617, Egypt

Location

Related Publications (1)

  • Bayoumi HM, Abdelaziz DH, Boraii S, Bendas ER, El Said NO. Intraperitoneal Granisetron for Post-Laparoscopic Cholecystectomy Pain Management: A Double-Blinded, Randomized Controlled Trial. Pharmacotherapy. 2025 Sep;45(9):547-556. doi: 10.1002/phar.70046. Epub 2025 Jul 23.

    PMID: 40698525DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

GranisetronSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant- Pharmacy Practice & Clinical Pharmacy

Study Record Dates

First Submitted

February 18, 2024

First Posted

February 28, 2024

Study Start

February 29, 2024

Primary Completion

December 4, 2024

Study Completion

December 4, 2024

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)