Pain, PostoperativePhase 4NCT05907993
Ibuprofen Versus Ketorolac For Postoperative Pain Relief After Cesarean Section
A Phase 4 study testing Ibuprofen 800 mg in people with Pain, Postoperative, run by Alexandria University at 1 site in Egypt.
Trial summary
The aim of this study will be to evaluate the effectiveness of intravenous ibuprofen versus intravenous ketorolac for postoperative pain relief after caesarian section 1. The Primary outcome is measurement of visual analogue score during rest and movement 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ibuprofen 800 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 30 Oct 2023
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parturients aged 20-30years.
- ASA physical satatus: II.
- Anticipated hospital stay for at least 24 hours.
- Refusal of spinal anaesthesia.
Who cannot join
- Known allergy to the used drugs.
- Renal and hepatic impairement
- History of brochial asthma.
- Low platelets count (<70000).
- Bleeding diathesis and with history or risk of intracranial hemorrhage.
- Obese and morbidly obese parturients.
- GIT problems as gastritis or GI bleeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness Of Intravenous Ibuprofen Versus Intravenous Ketorolac For Postoperative Pain Relief After Cesarean Section
The aim of this study will be to evaluate the effectiveness of intravenous ibuprofen versus intravenous ketorolac for postoperative pain relief after caesarian section
- The Primary outcome is measurement of visual analogue score during rest and movement
- The Secondary outcome is measurement of 24 hours opioids requirements.
Read the detailed description
METHODS
- Preoperative assessment:
All parturients included in the study will be assessed thoroughly by:
- Proper history taking
- Complete clinical examination.
- All needed laboratory investigations.
- Patient preparation:
- On arrival to the operative theatre , an 18 G intravenous cannula will be inserted in a peripheral vein
- Steps of general anaesthesia will be explained to the parturients.
Using a multichannel monitor (mindary) iMeC12 SHENZEN MINDRAY BIO-MEDICAL ELECTRONICS CO, LTD, CHINA, the parturients will be continuously monitored for:
- Non-invasive arterial blood pressure (NIBP) in (mmHg).
- Heart rate (beats/min).
- Oxygen saturation (percentage).
- End tidal carbon dioxide(mmhg). 3. Anaesthesia technique:
- Left uterine displacement will be maintained by a wedge under the right hip.
- Preoxygenation with 100% oxygen will be done for 3-5 minutes
- For both groups rapid sequence induction will be done with 2mg/kg propofol and 0.9 mg/kg rocuronium,50 microgram fentanyl followed by tracheal intubation and IPPV volume control.
- Anaesthesia will be maintained with 1.2% isoflurane in 100% Oxygen and 0.1 mg /kg roccuronium will be administrated if needed.
- After delivery oxytocin infusion 10 IU will be given
- After finishing operation , inhalational anaesthesia will be stopped and all parturients will receive 2mg/kg sugammadex when train of four is 75%.
- Then all parturients will be discharged to ward to be put under observation for 24 hours and they will receive NSAID immediately on arrival to the ward .
- Group A parturients will receive 30 mg ketorolac in 200 cc normal saline intravenously every 6 hours
- Group B parturients will receive 800 mg Ibuprofen in 200 cc normal saline intravenously every 6 hours
- All Parturients will receive 25 mg pethidine if visual analogue score (VAS) ≥4.
MEASUREMENTS
The following parameters will be measured for all parturients, in both groups:
- Demographic data: Age (years) Body Mass index ( kilogram/meters2) Weight (kilograms) Height (meters) Duration of surgery (minutes)
- Postoperative hemodynamics:
- Heart rate (beats/min)
- Blood pressure (mmHg)
- Baseline value immediately after extubation before giving any analgesia.
- Immediately and 2, 4, 6, 12, 24 hours after end of surgery.
- Visual analogue score:
- All parturients will be trained to use VAS. VAS at rest (VASR) and during movement (VASM) will be measured at 1,3,6,12,18,24 hours following surgery .The VAS score will be presented as 10 cm horizontal line anchored by the words "no pain"(corresponding to zero) and "worst pain possible"(corresponding to ten).The values will be scored as mild pain(from 1 to 3) ,moderate pain (from 4 to 6) and severe pain (from 7 to 10).
- If VAS is ≥4 parturients will receive 25mg pethidine iv.
- Opioid requirement During the first 24 hours after surgery(mg) The doses of pethidine required during the first 24 hours postoperatively will be calculated.
- Nocturnal awakening due to pain (percentage) The percentage of parturients who become awake at night due to pain
- Time to ambulate (minutes) The time the parturient takes to get out of bed and to do light activities such as sitting, standing or walking.
- Time to first analgesic dose (minutes) rescue analgesia The time when the patient require the first analgesic dose in the ward.
- Conditions
- Pain, Postoperative
- Being tested
- Ibuprofen 800 mg
- Keywords
- postoperative, pain relief, CESAREAN SECTION
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen 800 mgDrug
Intravenous Ibuprofen versus intravenous Ketorolac for postoperative pain relief
| Study group | Role | What they receive |
|---|---|---|
| Group (A): | No intervention | 30mg ketorolac in 200cc normal saline intravenously every 6hours for 24hours postoperatively. |
| Group (B): | Active comparator | 800mg ibuprofen in 200cc normal saline intravenously every 6 hours for 24hours postoperatively. Receives: Drug: Ibuprofen 800 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of visual analogue score
measurement of visual analogue score during rest and movement . The Score range from 0- 10 . 0 means no pain and 10 indicates the worst pain ever
Measured: after the surgery average 24 hours postoperative
Secondary outcomes (1)
opioids requirements.
Total opioid cumulative requirement dose
Measured: after the surgery average 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Feb 2023
- Primary completion30 Sep 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Alexandria 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shehab, MD, Alexandria University
- Investigators
- Ahmed S. Shehab, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907993
- Sponsor's protocol ID
- 0107307
- Status last verified
- Feb 2024
- First submitted
- 18 Apr 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 17\. there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers
Publications
Ekinci M, Ciftci B, Celik EC, Kose EA, Karakaya MA, Ozdenkaya Y. A Randomized, Placebo-Controlled, Double-Blind Study that Evaluates Efficacy of Intravenous Ibuprofen and Acetaminophen for Postoperative Pain Treatment Following Laparoscopic Cholecystectomy Surgery. J Gastrointest Surg. 2020 Apr;24(4):780-785. doi: 10.1007/s11605-019-04220-1. Epub 2019 Apr 22.
PubMed 31012040
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Of Intravenous Ibuprofen Versus Intravenous Ketorolac For Postoperative Pain Relief After Cesarean Section
- ClinicalTrials.gov ID
- NCT05907993
- Acronym / sponsor ID
- 0107307
- Conditions
- Pain, Postoperative
- Keywords
- postoperative, pain relief, CESAREAN SECTION
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 18 Jun 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 aim of this study will be to evaluate the effectiveness of intravenous ibuprofen versus intravenous ketorolac for postoperative pain relief after caesarian section
- The Primary outcome is measurement of visual analogue score during rest and movement
- The Secondary outcome is measurement of 24 hours opioids requirements.
Detailed description
METHODS
- Preoperative assessment:
All parturients included in the study will be assessed thoroughly by:
- Proper history taking
- Complete clinical examination.
- All needed laboratory investigations.
- Patient preparation:
- On arrival to the operative theatre , an 18 G intravenous cannula will be inserted in a peripheral vein
- Steps of general anaesthesia will be explained to the parturients.
Using a multichannel monitor (mindary) iMeC12 SHENZEN MINDRAY BIO-MEDICAL ELECTRONICS CO, LTD, CHINA, the parturients will be continuously monitored for:
- Non-invasive arterial blood pressure (NIBP) in (mmHg).
- Heart rate (beats/min).
- Oxygen saturation (percentage).
- End tidal carbon dioxide(mmhg). 3. Anaesthesia technique:
- Left uterine displacement will be maintained by a wedge under the right hip.
- Preoxygenation with 100% oxygen will be done for 3-5 minutes
- For both groups rapid sequence induction will be done with 2mg/kg propofol and 0.9 mg/kg rocuronium,50 microgram fentanyl followed by tracheal intubation and IPPV volume control.
- Anaesthesia will be maintained with 1.2% isoflurane in 100% Oxygen and 0.1 mg /kg roccuronium will be administrated if needed.
- After delivery oxytocin infusion 10 IU will be given
- After finishing operation , inhalational anaesthesia will be stopped and all parturients will receive 2mg/kg sugammadex when train of four is 75%.
- Then all parturients will be discharged to ward to be put under observation for 24 hours and they will receive NSAID immediately on arrival to the ward .
- Group A parturients will receive 30 mg ketorolac in 200 cc normal saline intravenously every 6 hours
- Group B parturients will receive 800 mg Ibuprofen in 200 cc normal saline intravenously every 6 hours
- All Parturients will receive 25 mg pethidine if visual analogue score (VAS) ≥4.
MEASUREMENTS
The following parameters will be measured for all parturients, in both groups:
- Demographic data: Age (years) Body Mass index ( kilogram/meters2) Weight (kilograms) Height (meters) Duration of surgery (minutes)
- Postoperative hemodynamics:
- Heart rate (beats/min)
- Blood pressure (mmHg)
- Baseline value immediately after extubation before giving any analgesia.
- Immediately and 2, 4, 6, 12, 24 hours after end of surgery.
- Visual analogue score:
- All parturients will be trained to use VAS. VAS at rest (VASR) and during movement (VASM) will be measured at 1,3,6,12,18,24 hours following surgery .The VAS score will be presented as 10 cm horizontal line anchored by the words "no pain"(corresponding to zero) and "worst pain possible"(corresponding to ten).The values will be scored as mild pain(from 1 to 3) ,moderate pain (from 4 to 6) and severe pain (from 7 to 10).
- If VAS is ≥4 parturients will receive 25mg pethidine iv.
- Opioid requirement During the first 24 hours after surgery(mg) The doses of pethidine required during the first 24 hours postoperatively will be calculated.
- Nocturnal awakening due to pain (percentage) The percentage of parturients who become awake at night due to pain
- Time to ambulate (minutes) The time the parturient takes to get out of bed and to do light activities such as sitting, standing or walking.
- Time to first analgesic dose (minutes) rescue analgesia The time when the patient require the first analgesic dose in the ward.
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 |
|---|---|---|
| Group (A): | No intervention | –30mg ketorolac in 200cc normal saline intravenously every 6hours for 24hours postoperatively. |
| Group (B): | Active comparator | Drug: Ibuprofen 800 mg800mg ibuprofen in 200cc normal saline intravenously every 6 hours for 24hours postoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parturients aged 20-30years.
- ASA physical satatus: II.
- Anticipated hospital stay for at least 24 hours.
- Refusal of spinal anaesthesia.
Key exclusion criteria (7 listed)
- Known allergy to the used drugs.
- Renal and hepatic impairement
- History of brochial asthma.
- Low platelets count (<70000).
- Bleeding diathesis and with history or risk of intracranial hemorrhage.
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 |
|---|---|---|
| Ibuprofen 800 mgIntravenous Ibuprofen versus intravenous Ketorolac for postoperative pain relief | Drug | Group (B): |
Primary outcome
measurement of visual analogue score
Time frame: after the surgery average 24 hours postoperative
measurement of visual analogue score during rest and movement . The Score range from 0- 10 . 0 means no pain and 10 indicates the worst pain ever
1 secondary outcome
opioids requirements.
Time frame: after the surgery average 24 hours postoperative
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 28 Feb 2024.
- Background: PubMed 31012040Ekinci M, Ciftci B, Celik EC, Kose EA, Karakaya MA, Ozdenkaya Y. A Randomized, Placebo-Controlled, Double-Blind Study that Evaluates Efficacy of Intravenous Ibuprofen and Acetaminophen for Postoperative Pain Treatment Following Laparoscopic Cholecystectomy Surgery. J Gastrointest Surg. 2020 Apr;24(4):780-785. doi: 10.1007/s11605-019-04220-1. Epub 2019 Apr 22.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 17. there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 S. Shehab, MD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen 800 mg in people with Pain, Postoperative, run by Alexandria 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 4 inclusion and 7 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 28 Feb 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
measurement of visual analogue score (time frame: after the surgery average 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05907993, which also lists 1 linked publication.
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 28 Feb 2024.