Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy

Phase 2

Active, not recruiting

• Conditions: Post Operative Analgesia
• Interventions: Drug: Ibuprofen

• Registration Number: NCT05750264
• Lead Sponsor: Menoufia University

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.

Study Timeline

• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-03-01
• Study Start: 2023-03-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ibuprofen group	Ibuprofen	intravenous ibuprofen 800mg in 200 ml normal saline+IV paracetamol 1000mg+Transversus abdominis plane block

Primary Outcome Measures

Name	Time	Method
Morphine consumption	Postoperative up to 24 hours	mg

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Cairo, Shebin Elkom, Egypt