Postoperative Intraperitoneal Pain Management Following Laparoscopic Cholecystectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2024-12-04

Brief Summary

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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.

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Detailed Description

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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 IP granisetron on postoperative pain control in patients undergoing LC

Conditions

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Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control arm

2 ml IP normal saline (0.9 % NaCl)

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type OTHER

2 ml IP normal saline (0.9% NaCl)

Intervention arm

2ml IP granisetron (1 mg/mL)

Group Type EXPERIMENTAL

Granisetron 1 Mg/mL Intravenous Solution

Intervention Type DRUG

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

Interventions

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Granisetron 1 Mg/mL Intravenous Solution

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

Intervention Type DRUG

Normal saline

2 ml IP normal saline (0.9% NaCl)

Intervention Type OTHER

Eligibility Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No