Postoperative AnalgesiaNCT07244757
Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control
A study testing Ketorolac 30 mg and Ketorolac 15mg in people with Postoperative Analgesia and Cesarean Delivery, run by Cairo University at 1 site in Egypt.
Trial summary
we aim to compare the analgesic efficacy of two intravenous ketorolac dosing regimens as part of a multimodal analgesic protocol that includes local wound infiltration for postoperative pain management after elective cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Postoperative Analgesia, Cesarean Delivery, Ketorolac
- What is being tested?
- Ketorolac 30 mg and Ketorolac 15mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2025to 29 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- full-term, singleton, pregnant women,
- aged 18-35 years,
- scheduled for elective cesarean delivery under spinal anesthesia
Who cannot join
- American Society of Anesthesiologists (ASA) physical class III or more
- multiple gestation. Patients with a history of allergy to any of the study drugs,
- renal impairment,
- gastrointestinal bleeding or ulceration
- inflammatory bowel disease,
- chronic pain or regular opioid use.
- Inability to comprehend the numeric pain scale (NRS) or the ObsQoR-11 score
- requirement for conversion to general anesthesia after spinal anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control: A Randomized Controlled Trial
we aim to compare the analgesic efficacy of two intravenous ketorolac dosing regimens as part of a multimodal analgesic protocol that includes local wound infiltration for postoperative pain management after elective cesarean delivery.
Read the detailed description
Spinal anesthesia will be achieved by injecting 10 mg hyperbaric bupivacaine 0.5% plus 25 mcg fentanyl Prophylactic vasopressor will be administered in all patients, Following delivery, all patients will receive a single dose of dexamethasone (8 mg) along with the first dose of intravenous ketorolac. Subsequent ketorolac doses will be administered every 8 hours.
After closing the fascia, the subcutaneous layer will be infiltrated with 30 mL of 0.25% bupivacaine.
Postoperatively, if the Numeric rating scale is > 3, intravenous nalbuphine 0.1 mg/kg titrated to response, with maximum single dose of 20 mg and maximum daily dose of 160 mg.
- Conditions
- Postoperative Analgesia, Cesarean Delivery, Ketorolac
- Being tested
- Ketorolac 30 mg, Ketorolac 15mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac 30 mgDrug
administered intravenously as 30 mg diluted in 10 mL of normal saline and injected over more than 15 seconds
Ketorolac 15mgDrug
administered intravenously as either 15 mg diluted in 10 mL of normal saline and injected over more than 15 seconds.
| Study group | Role | What they receive |
|---|---|---|
| ketorolac 30 | Active comparator | patients will receive intravenous ketorolac at 30 mg/8 h postoperatively Receives: Drug: Ketorolac 30 mg |
| ketorolac 15 mg | Active comparator | patients will receive intravenous ketorolac at 15 mg/8 h postoperatively Receives: Drug: Ketorolac 15mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale at rest
the patient rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable"
Measured: 6 hours postoperatively
Secondary outcomes (6)
numeric rating scale at rest
person rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable"
Measured: at 30 minutes, 12-, 18-, and 24 hours postoperatively
numeric rating scale during movement
person rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable" during change position from supine to sitting or ambulation
Measured: at 30 minutes, 6-, 12-, 18-, and 24 hours postoperatively
total nalbuphine consumption
mg
Measured: from 0.5 hour postoperatively to 24 hour postoperatively
time to first analgesic requirement
hours
Measured: time from immediately postoperatively to time of first analgesic requirement during the first 24 hours
ObsQoR-11 score
The ObsQoR-11 is an 11-item questionnaire to assess a patient's recovery after a C-section, with a total score ranging from 0 to 100, where 100 is the best possible recovery
Measured: 24 hour postoperatively
patient's satisfaction
At the end of the study the patient will be asked to rate her satisfaction with pain control using the NRS 10= strongly unsatisfied, 0= strongly satisfied
Measured: 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Dec 2025
- Primary completion28 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Cairo 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hasanin, Cairo University
- Investigators
- ahmed hasanin, Principal investigator, Cairo University Kasr Alainy Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244757
- Sponsor's protocol ID
- MS-390-2025
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: data used for analysis will be available from the PI upon reasonable requist
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07244757
- Acronym / sponsor ID
- MS-390-2025
- Conditions
- Postoperative Analgesia, Cesarean Delivery, Ketorolac
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 24 Nov 2025 (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.
we aim to compare the analgesic efficacy of two intravenous ketorolac dosing regimens as part of a multimodal analgesic protocol that includes local wound infiltration for postoperative pain management after elective cesarean delivery.
Detailed description
Spinal anesthesia will be achieved by injecting 10 mg hyperbaric bupivacaine 0.5% plus 25 mcg fentanyl Prophylactic vasopressor will be administered in all patients, Following delivery, all patients will receive a single dose of dexamethasone (8 mg) along with the first dose of intravenous ketorolac. Subsequent ketorolac doses will be administered every 8 hours.
After closing the fascia, the subcutaneous layer will be infiltrated with 30 mL of 0.25% bupivacaine.
Postoperatively, if the Numeric rating scale is > 3, intravenous nalbuphine 0.1 mg/kg titrated to response, with maximum single dose of 20 mg and maximum daily dose of 160 mg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketorolac 30 | Active comparator | Drug: Ketorolac 30 mgpatients will receive intravenous ketorolac at 30 mg/8 h postoperatively |
| ketorolac 15 mg | Active comparator | Drug: Ketorolac 15mgpatients will receive intravenous ketorolac at 15 mg/8 h postoperatively |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- full-term, singleton, pregnant women,
- aged 18-35 years,
- scheduled for elective cesarean delivery under spinal anesthesia
Key exclusion criteria (8 listed)
- American Society of Anesthesiologists (ASA) physical class III or more
- multiple gestation. Patients with a history of allergy to any of the study drugs,
- renal impairment,
- gastrointestinal bleeding or ulceration
- inflammatory bowel disease,
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 |
|---|---|---|
| Ketorolac 30 mgadministered intravenously as 30 mg diluted in 10 mL of normal saline and injected over more than 15 seconds | Drug | ketorolac 30 |
| Ketorolac 15mgadministered intravenously as either 15 mg diluted in 10 mL of normal saline and injected over more than 15 seconds. | Drug | ketorolac 15 mg |
Primary outcome
numeric rating scale at rest
Time frame: 6 hours postoperatively
the patient rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable"
6 secondary outcomes
numeric rating scale at rest
Time frame: at 30 minutes, 12-, 18-, and 24 hours postoperatively
numeric rating scale during movement
Time frame: at 30 minutes, 6-, 12-, 18-, and 24 hours postoperatively
total nalbuphine consumption
Time frame: from 0.5 hour postoperatively to 24 hour postoperatively
time to first analgesic requirement
Time frame: time from immediately postoperatively to time of first analgesic requirement during the first 24 hours
ObsQoR-11 score
Time frame: 24 hour postoperatively
patient's satisfaction
Time frame: 24 hour postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Yes. data used for analysis will be available from the PI upon reasonable requist
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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.
ahmed hasanin principal investigator
Cairo University Kasr Alainy Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac 30 mg and Ketorolac 15mg in people with Postoperative Analgesia and Cesarean Delivery, run by Cairo 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 17 Jun 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
numeric rating scale at rest (time frame: 6 hours postoperatively). 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 17 Jun 2026.