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Clinical Trials/NCT05750264
NCT05750264
Active, not recruiting
Phase 2

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

Menoufia University1 site in 1 country152 target enrollmentMarch 4, 2023
InterventionsIbuprofen

Overview

Phase
Phase 2
Intervention
Ibuprofen
Conditions
Post Operative Analgesia
Sponsor
Menoufia University
Enrollment
152
Locations
1
Primary Endpoint
Morphine consumption
Status
Active, not recruiting
Last Updated
12 months ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
March 4, 2023
End Date
December 2025
Last Updated
12 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Abd-Elazeem Abd-Elhameed Elbakry

Assistant professor

Menoufia University

Eligibility Criteria

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.

Arms & Interventions

ibuprofen group

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

Intervention: Ibuprofen

Outcomes

Primary Outcomes

Morphine consumption

Time Frame: Postoperative up to 24 hours

mg

Secondary Outcomes

  • Arterial oxygen saturation(Perioperative)
  • End tidal carbon dioxide(Perioperative)
  • Time of first ambulation(First postoperative 24 hours)
  • Duration of hospital stay(Postoperative up to 4 weeks)
  • Pain intensity(Postoperative up to 24 hours)
  • Anaesthesia recovery time(Perioperative)
  • Respiratory rate(Perioperative)
  • Heart rate(Perioperative)
  • Duration of post anaesthesia care unit stay(First postoperative 24 hours)
  • Mean arterial blood pressure(Perioperative)

Study Sites (1)

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