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Ibuprofen Use on Post-operative Pain Following Cholecystectomy

NCT06478758 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-06-27

No results posted yet for this study

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.

Conditions

  • Acute Post-operative Pain

Interventions

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.

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.

Sponsors & Collaborators

  • Giresun University

    lead OTHER

Principal Investigators

  • Azime Bulut, MD · Giresun University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06478758 on ClinicalTrials.gov