NCT05750264

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 4, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

February 12, 2023

Last Update Submit

May 5, 2025

Conditions

Post Operative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    mg

    Postoperative up to 24 hours

Secondary Outcomes (10)

  • Pain intensity

    Postoperative up to 24 hours

  • Anaesthesia recovery time

    Perioperative

  • Duration of post anaesthesia care unit stay

    First postoperative 24 hours

  • Time of first ambulation

    First postoperative 24 hours

  • Duration of hospital stay

    Postoperative up to 4 weeks

  • +5 more secondary outcomes

Study Arms (2)

ibuprofen group

ACTIVE COMPARATOR

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

Drug: Ibuprofen

Control group

NO INTERVENTION

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

Interventions

IbuprofenDRUG

800 mg of IV ibuprofen

ibuprofen group

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Cairo, Shebin Elkom, Egypt

Location

MeSH Terms

Interventions

Ibuprofen

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Abd-Elazeem A Elbakry, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

  • Amal G Safan, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

  • Sadik A Sadik, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2023

First Posted

March 1, 2023

Study Start

March 4, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 6, 2025

Record last verified: 2025-05

Locations

EG(1)