Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-25 @ 4:03 PM
Study NCT ID:
NCT07244757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-16', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numeric rating scale at rest', 'timeFrame': '6 hours postoperatively', 'description': 'the patient rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable"'}], 'secondaryOutcomes': [{'measure': 'numeric rating scale at rest', 'timeFrame': 'at 30 minutes, 12-, 18-, and 24 hours postoperatively', 'description': 'person rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable"'}, {'measure': 'numeric rating scale during movement', 'timeFrame': 'at 30 minutes, 6-, 12-, 18-, and 24 hours postoperatively', 'description': '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'}, {'measure': 'total nalbuphine consumption', 'timeFrame': 'from 0.5 hour postoperatively to 24 hour postoperatively', 'description': 'mg'}, {'measure': 'time to first analgesic requirement', 'timeFrame': 'time from immediately postoperatively to time of first analgesic requirement during the first 24 hours', 'description': 'hours'}, {'measure': 'ObsQoR-11 score', 'timeFrame': '24 hour postoperatively', 'description': "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"}, {'measure': "patient's satisfaction", 'timeFrame': '24 hour postoperatively', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Analgesia', 'Cesarean Delivery', 'Ketorolac']}, 'descriptionModule': {'briefSummary': 'Ketorolac, an intravenous NSAID widely used in perioperative pain management, has been shown to reduce pain scores and opioid requirements following cesarean delivery. However, its optimal dosing regimen remains uncertain, with previous studies using doses ranging from 15 mg to 60 mg. A retrospective analysis found no significant difference between 15 mg and 30 mg doses when combined with neuraxial opioids, possibly due to overlapping multimodal analgesia components. To date, no study has directly compared 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.', 'detailedDescription': "Thirty minutes before the surgery, all patients will receive 1 gm paracetamol orally then every 6 h postoperatively (initially intravenously, then orally once oral intake is permitted) Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and pre-medication drugs will be delivered (metoclopramide 10 mg). Lactated Ringer's co-load will be rapidly infused at a rate of 15 mL.Kg-1 over 10 minutes \\[10\\]. Spinal anesthesia will be achieved by injecting 10 mg hyperbaric bupivacaine 0.5% plus 25 mcg fentanyl in L3-L4 or L4-L5 interspace. Prophylactic vasopressor will be administered in all patients, either ephedrine bolus (9 mg) or norepinephrine infusion (0.08 mcg/kg/min) according to the preference of the attending physician.\n\nFollowing 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.\n\nAfter closing the fascia, the subcutaneous layer will be infiltrated by the obstetrician in charge using a sterile needle along the line of the wound in 3 to 4 separate portions, 15 mL of 0.25% bupivacaine on each side (30 mL total volume).\n\nPostoperatively, pain assessments using the NRS will be performed at rest and during movement (change position from supine to sitting or ambulation) at 0.5, 6, 12, 18, and 24 h after leaving the operating room. If the NRS score 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.\n\nIntravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting.\n\nAt the end of the 24-h postoperatively, the quality of recovery will be assessed using the ObsQoR-11 score."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* full-term, singleton, pregnant women,\n* aged 18-35 years,\n* scheduled for elective cesarean delivery under spinal anesthesia\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical class III or more\n* multiple gestation. Patients with a history of allergy to any of the study drugs,\n* renal impairment,\n* gastrointestinal bleeding or ulceration\n* inflammatory bowel disease,\n* chronic pain or regular opioid use.\n* Inability to comprehend the numeric pain scale (NRS) or the ObsQoR-11 score\n* requirement for conversion to general anesthesia after spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT07244757', 'briefTitle': 'Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MS-390-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ketorolac 30', 'description': 'patients will receive intravenous ketorolac at 30 mg/8 h postoperatively', 'interventionNames': ['Drug: Ketorolac 30 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ketorolac 15 mg', 'description': 'patients will receive intravenous ketorolac at 15 mg/8 h postoperatively', 'interventionNames': ['Drug: Ketorolac 15mg']}], 'interventions': [{'name': 'Ketorolac 30 mg', 'type': 'DRUG', 'description': 'administered intravenously as 30 mg diluted in 10 mL of normal saline and injected over more than 15 seconds', 'armGroupLabels': ['ketorolac 30']}, {'name': 'Ketorolac 15mg', 'type': 'DRUG', 'description': 'administered intravenously as either 15 mg diluted in 10 mL of normal saline and injected over more than 15 seconds.', 'armGroupLabels': ['ketorolac 15 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'ahmed hasanin', 'role': 'CONTACT', 'email': 'ahmedmohamedhasanin@gmail.com', 'phone': '01095076954', 'phoneExt': '+2'}], 'facility': 'Kasr Alainy Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Maha Mostafa, MD', 'role': 'CONTACT', 'email': 'maha.mostafa@cu.edu.eg', 'phone': '+201000365115', 'phoneExt': '+2'}], 'overallOfficials': [{'name': 'ahmed hasanin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University Kasr Alainy Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'data used for analysis will be available from the PI upon reasonable requist'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ahmed Hasanin', 'investigatorAffiliation': 'Cairo University'}}}}