Clinical trial

Postoperative Pain Management Following Laparoscopic Cholecystectomy- Intraperitoneal Granisetron

Name

5-24

Description

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 arms

Trial start

2024-02-29

Estimated PCD

2024-10-01

Trial end

2024-10-01

Status

Recruiting

Phase

Early phase I

Treatment

Granisetron 1 Mg/mL Intravenous Solution

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

Arms:

Intervention arm

Normal saline

2 ml IP normal saline (0.9% NaCl)

Arms:

Control arm

Size

Primary endpoint

VAS score

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

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 46, 'type': 'ESTIMATED'}}

Updated at

2024-04-17

1 organization

1 product

1 indication

Organization

Future University in Egypt

Product

Granisetron

Indication

Postoperative Pain