Ibuprofen Use on Post-operative Pain Following Cholecystectomy

Phase 4

Completed

• Conditions: Acute Post-operative Pain
• Interventions: Drug: Ibuprofen 400 mg; Drug: Acetaminophen 100 MG/ML

• Registration Number: NCT06478758
• Lead Sponsor: Giresun University

Brief Summary

In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen.

Detailed Description

Ibuprofen is a widely used NSAID that has antipyretic, analgesic, and anti-inflammatory effects. In this study, the investigators compared the effects of IV forms of ibuprofen and acetaminophen on pain perception and opioid consumption following laparoscopic cholecystectomy.The participants in this study were randomized into two groups. Participants in Group I (group ibuprofen, n=35) were administered 800 mg of IV ibuprofen; participants in Group A (group acetaminophen, n=36) were administered 1000 mg of IV acetaminophen. The investigators recorded demographic data including gender, age, ASA, BMI, duration of anesthesia and surgery, poNV, LOS, VAS scores and opioid consumption postoperatively.

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-24
• Last Update Submitted: 2024-06-24
• Study First Posted: 2024-06-27
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• ASA grade I-II patients
• Aged 18-65 years

Exclusion Criteria

• History of allergies or hypersensitivity to the aforementioned agents
• Renal, hepatic or gastrointestinal disease
• Significant cognitive impairment
• Recent use of long-term nonsteroid anti-inflammatory and opioids
• Oral anticoagulant use or known bleeding disorders
• Diabetes or any other neuropathic diseases
• Pregnancy or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen group	Ibuprofen 400 mg	The ibuprofen group (n=36) was administered 800 mg of ibuprofen at the end of the cholecystectomy.
Acetaminophen group	Acetaminophen 100 MG/ML	The acetaminophen group (n=35) received 1000 of mg acetaminophen intravenously in 100 mL saline at the end of the cholecystectomy.

Primary Outcome Measures

Name	Time	Method
VAS scores in the postoperative period	24 hour	Primary outcome was to reduce the VAS scores in the postoperative period. For this purpose the investigators recorded VAS scores at the 1, 2, 6, 12 and 24 h postoperatively.

Secondary Outcome Measures

Name	Time	Method
Opioid consumption and length of stay	24 hour	Secondary outcome was any decrease in opioid consumption and hospitalization.

Trial Locations

Locations (1)

Giresun University; 🇹🇷 Giresun, Turkey