Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy

Post Operative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05750264
• Other study ID #: 2/2023 ANET10-1
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 4, 2023
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 152
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post Operative Analgesia

Intervention

Drug:
• Ibuprofen
800 mg of IV ibuprofen

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo	Shebin Elkom

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

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