Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy

May 5, 2025 updated by: Abd-Elazeem Abd-Elhameed Elbakry, Menoufia University

Efficacy of Intravenous Ibuprofen in Multimodal Pain Management After Open Abdominal Hysterectomy: A Randomised Trial

The current research is designed to investigate the analgesic efficacy of intravenous ibuprofen on the postoperative analgesic requirements, pain intensity and other recovery parameters.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The patients will be given general anaesthesia. Anaesthesia will be induced by propofol 1-2 mg/kg, and fentanyl 1-2 µg/kg. Endotracheal intubation will be facilitated by atracurium 0.5 mg/kg. Anaesthesia will be maintained by isoflurane in oxygen - air mixture. Transversus abdominis plane block will be performed at the end of the operation. A postoperative analgesic regimen according to group allocation will be started.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 2

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

  • Egypt
    • Shebin Elkom
      • Cairo, Shebin Elkom, Egypt
        • Faculty of Medicine

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of anaesthesiologists physical status I to III.
  • Open abdominal hysterectomy operations

Exclusion Criteria:

  • History of gastrointestinal bleeding.
  • History of intracranial haemorrhage.
  • Pregnancy and lactation.
  • Taking angiotensin converting enzyme(ACE) inhibitors or anticoagulation drugs.
  • Asthmatic, hepatic,renal or heart failure.
  • Abnormal platelet count.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ibuprofen group
intravenous ibuprofen 800mg in 200 ml normal saline+IV paracetamol 1000mg+Transversus abdominis plane block
Drug: Ibuprofen
800 mg of IV ibuprofen
No Intervention: Control group
200 ml normal saline+IV paracetamol1000mg+Transversus abdominis plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine consumption
Time Frame: Postoperative up to 24 hours
mg
Postoperative up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean arterial blood pressure
Time Frame: Perioperative
mmHg
Perioperative
Pain intensity
Time Frame: Postoperative up to 24 hours
Visual analogue score: a score from 0 to 10( 0= no pain and 10 the worst imaginable pain)
Postoperative up to 24 hours
Anaesthesia recovery time
Time Frame: Perioperative
Minutes
Perioperative
Duration of post anaesthesia care unit stay
Time Frame: First postoperative 24 hours
Minutes
First postoperative 24 hours
Time of first ambulation
Time Frame: First postoperative 24 hours
Minutes
First postoperative 24 hours
Duration of hospital stay
Time Frame: Postoperative up to 4 weeks
Days
Postoperative up to 4 weeks
Heart rate
Time Frame: Perioperative
Beats/minute
Perioperative
Arterial oxygen saturation
Time Frame: Perioperative
Percentage
Perioperative
End tidal carbon dioxide
Time Frame: Perioperative
mmHg
Perioperative
Respiratory rate
Time Frame: Perioperative
Breath/minute
Perioperative

Collaborators and Investigators

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

Sponsor

Menoufia University

Investigators

  • Principal Investigator: Abd-Elazeem A Elbakry, MD, Menoufia University
  • Principal Investigator: AMAL G SAFAN, MD, Menoufia University
  • Principal Investigator: Sadik A Sadik, MD, Menoufia University

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)

March 4, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/2023 ANET10-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Subscribe