Post Operative AnalgesiaPhase 2NCT05750264
Intravenous Ibuprofen Postoperative Analgesia After Abdominal Hysterectomy
A Phase 2 study testing Ibuprofen in people with Post Operative Analgesia, run by Menoufia University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Post Operative Analgesia
- What is being tested?
- Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Mar 2023to May 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of anaesthesiologists physical status I to III.
- Open abdominal hysterectomy operations
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intravenous Ibuprofen in Multimodal Pain Management After Open Abdominal Hysterectomy: A Randomised Trial
The current research is designed to investigate the analgesic efficacy of intravenous ibuprofen on the postoperative analgesic requirements, pain intensity and other recovery parameters.
Read the 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.
- Conditions
- Post Operative Analgesia
- Being tested
- Ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
800 mg of IV ibuprofen
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen group | Active comparator | intravenous ibuprofen 800mg in 200 ml normal saline+IV paracetamol 1000mg+Transversus abdominis plane block Receives: Drug: Ibuprofen |
| Control group | No intervention | 200 ml normal saline+IV paracetamol1000mg+Transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
mg
Measured: Postoperative up to 24 hours
Secondary outcomes (10)
Pain intensity
Visual analogue score: a score from 0 to 10( 0= no pain and 10 the worst imaginable pain)
Measured: Postoperative up to 24 hours
Anaesthesia recovery time
Minutes
Measured: Perioperative
Duration of post anaesthesia care unit stay
Minutes
Measured: First postoperative 24 hours
Time of first ambulation
Minutes
Measured: First postoperative 24 hours
Duration of hospital stay
Days
Measured: Postoperative up to 4 weeks
Heart rate
Beats/minute
Measured: Perioperative
Mean arterial blood pressure
mmHg
Measured: Perioperative
Arterial oxygen saturation
Percentage
Measured: Perioperative
End tidal carbon dioxide
mmHg
Measured: Perioperative
Respiratory rate
Breath/minute
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start4 Mar 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amal Gouda Elsayed Safan, Menoufia University
- Investigators
- Abd-Elazeem A Elbakry, MD, Principal investigator, Menoufia UniversityAmal G Safan, MD, Principal investigator, Menoufia UniversitySadik A Sadik, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750264
- Sponsor's protocol ID
- 2/2023 ANET10-1
- Status last verified
- Oct 2026
- First submitted
- 12 Feb 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No