Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy

NCT ID: NCT05750264

Last Updated: 2025-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-04

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Post Operative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ibuprofen group

intravenous ibuprofen 800mg in 200 ml normal saline+IV paracetamol 1000mg+Transversus abdominis plane block

Group Type ACTIVE_COMPARATOR

Ibuprofen

Intervention Type DRUG

800 mg of IV ibuprofen

Control group

200 ml normal saline+IV paracetamol1000mg+Transversus abdominis plane block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ibuprofen

800 mg of IV ibuprofen

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Abd-Elazeem Abd-Elhameed Elbakry

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abd-Elazeem A Elbakry, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Amal G Safan, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Sadik A Sadik, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Locations

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Faculty of Medicine

Cairo, Shebin Elkom, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2/2023 ANET10-1

Identifier Type: -

Identifier Source: org_study_id

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