Ibuprofen Use on Post-operative Pain Following Cholecystectomy

June 24, 2024 updated by: Giresun University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Giresun, Turkey
        • Giresun University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acetaminophen group
The acetaminophen group (n=35) received 1000 of mg acetaminophen intravenously in 100 mL saline at the end of the cholecystectomy.
Drug: Acetaminophen 100 MG/ML
The investigators administered 1000 mg of acetaminophen to the participants in Group A. A 20% increase in the participant's heart rate and mean arterial pressure was evaluated as pain and remifentanil infusion was administered. All participants continued to receive the routine application of acetaminophen at 8-hour intervals, and tramadol was given to those with a visual analog score above 4, postoperatively.In the recovery room, participants with a visual analog score of > 4 were administered 100 mg of tramadol. All participants were prescribed acetaminophen every 8 hours postoperatively in whilst on the ward. Participants with a visual analog score of > 4 received rescue analgesia with 100 mg of tramadol. Visual analog score and vital parameters were recorded at 1, 2, 6, 12 and 24 h postoperatively. The incidence of nausea and vomiting during the 24 h postoperative period was also recorded.
Experimental: Ibuprofen group
The ibuprofen group (n=36) was administered 800 mg of ibuprofen at the end of the cholecystectomy.
Drug: Ibuprofen 400 mg
The ibuprofen group (n=36) was administered 800 mg of ibuprofen . All procedures were performed with the same team. During surgery, a 20% increase in the participant's heart rate and mean arterial pressure remifentanil infusion was administered. During the postoperative period, all participants continued to receive acetaminophen at 8-hour intervals, and tramadol was given to those with a visual analog score above 4. In the recovery room, the participants with a visual analog score of > 4 were administered 100 mg of tramadol. All participants were prescribed acetaminophen every 8 hours postoperatively in whilst on the ward. Participants with a visual analog score of > 4 received rescue analgesia with 100 mg of tramadol. Visual analog score and vital parameters were recorded at 1, 2, 6, 12 and 24 h postoperatively. The incidence of nausea and vomiting during the 24 h postoperative period was also recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption and length of stay
Time Frame: 24 hour
Secondary outcome was any decrease in opioid consumption and hospitalization.
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Giresun University

Investigators

  • Principal Investigator: Azime Bulut, MD, Giresun University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAEK-230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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