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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Ibuprofen in Multimodal Pain Management After Open Abdominal Hysterectomy: A Randomised Trial
- ClinicalTrials.gov ID
- NCT05750264
- Acronym / sponsor ID
- 2/2023 ANET10-1
- Conditions
- Post Operative Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ibuprofen group | Active comparator | Drug: Ibuprofenintravenous ibuprofen 800mg in 200 ml normal saline+IV paracetamol 1000mg+Transversus abdominis plane block |
| Control group | No intervention | –200 ml normal saline+IV paracetamol1000mg+Transversus abdominis plane block |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of anaesthesiologists physical status I to III.
- Open abdominal hysterectomy operations
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen800 mg of IV ibuprofen | Drug | ibuprofen group |
Primary outcome
Morphine consumption
Time frame: Postoperative up to 24 hours
mg
10 secondary outcomes
Pain intensity
Time frame: Postoperative up to 24 hours
Anaesthesia recovery time
Time frame: Perioperative
Duration of post anaesthesia care unit stay
Time frame: First postoperative 24 hours
Time of first ambulation
Time frame: First postoperative 24 hours
Duration of hospital stay
Time frame: Postoperative up to 4 weeks
Heart rate
Time frame: Perioperative
Mean arterial blood pressure
Time frame: Perioperative
Arterial oxygen saturation
Time frame: Perioperative
End tidal carbon dioxide
Time frame: Perioperative
Respiratory rate
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
Related trials for Post Operative Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abd-Elazeem A Elbakry, MD principal investigator
Menoufia University
Amal G Safan, MD principal investigator
Menoufia University
Sadik A Sadik, MD principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ibuprofen in people with Post Operative Analgesia, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: Postoperative up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.