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Clinical Trials/NCT06478758
NCT06478758
Completed
Phase 4

Ibuprofen Use on Post-operative Pain Following Cholecystectomy

Giresun University1 site in 1 country71 target enrollmentFebruary 1, 2024

Overview

Phase
Phase 4
Intervention
Acetaminophen 100 MG/ML
Conditions
Acute Post-operative Pain
Sponsor
Giresun University
Enrollment
71
Locations
1
Primary Endpoint
VAS scores in the postoperative period
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2024
End Date
April 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Acetaminophen group

The acetaminophen group (n=35) received 1000 of mg acetaminophen intravenously in 100 mL saline at the end of the cholecystectomy.

Intervention: Acetaminophen 100 MG/ML

Ibuprofen group

The ibuprofen group (n=36) was administered 800 mg of ibuprofen at the end of the cholecystectomy.

Intervention: Ibuprofen 400 mg

Outcomes

Primary Outcomes

VAS scores in the postoperative period

Time Frame: 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 Outcomes

  • Opioid consumption and length of stay(24 hour)

Study Sites (1)

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