Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 8:58 PM
Study NCT ID:
NCT07380568
Status:
RECRUITING
Last Update Posted:
2026-02-02
First Post:
2025-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin on Post Operative Pain After CS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008550', 'term': 'Melatonin'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-24', 'studyFirstSubmitDate': '2025-12-28', 'studyFirstSubmitQcDate': '2026-01-24', 'lastUpdatePostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain intensity measured using the VAS (Visual Analogue Scale)', 'timeFrame': '2, 6, 12, and 24 hours post-surgery.', 'description': 'it typically consists of a 100 mm straight line with descriptive anchors at each end representing the extremes of the sensation (for example, "no pain" at one end and "the most severe pain imaginable" at the other). Respondents indicate their experience by marking a point on the line, and the distance from the lower anchor is measured and recorded as a continuous variable'}], 'secondaryOutcomes': [{'measure': 'first rescue analgesia', 'timeFrame': 'the first 24 hours post operative', 'description': 'Time to first request for analgesia postoperatively'}, {'measure': 'Total opioid consumption', 'timeFrame': 'the first 24 hours post operative', 'description': 'amount of opioid requested by the patient'}, {'measure': 'Incidence of adverse effects', 'timeFrame': 'first 24 hours post operative', 'description': 'such as nausea, vomiting, headache, dizziness, sedation'}, {'measure': 'Time to first ambulation post-surgery', 'timeFrame': 'first 24 hours post operative', 'description': 'first movement by the patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['melatonin and pain after C.S'], 'conditions': ['Pain Management', 'Pain After Surgery', 'Cesarean Section Pain']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if melatonin will decrease pain after C.S. The main questions it aims to answer are:\n\nDoes melatonin lower the number of times participants need to use a rescue analgesia? What medical problems do participants have when taking melatonin? Researchers will compare different doses of melatonin to see the ideal dose to decrease pain after C.S.\n\nParticipants will:\n\nTake melatonin 30 min before C.S and will be observed for 24 hours for pain and consumption of other analgesia'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Women aged 18-40 years.\n* Scheduled for elective cesarean section.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Known hypersensitivity to melatonin or opioids\n* Chronic use of analgesics, sedatives, or antidepressants.\n* History of sleep disorders or psychiatric illness.\n* Complicated pregnancies (e.g., preeclampsia, gestational diabetes).\n* Body mass index (BMI) \\> 35 kg/m².\n* Emergency cesarean sections.\n* Severe systemic diseases (e.g., liver or kidney dysfunction).'}, 'identificationModule': {'nctId': 'NCT07380568', 'acronym': 'CS', 'briefTitle': 'Melatonin on Post Operative Pain After CS', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'The Effect of Preoperative Oral Melatonin on Postoperative Pain Control After Cesarean Section: A Dose Comparison Study', 'orgStudyIdInfo': {'id': 'RC.3.9.2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I: (5 mg melatonin)', 'interventionNames': ['Drug: Melatonin 5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II: (10 mg melatonin)', 'interventionNames': ['Drug: Melatonin 10 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group III: (Placebo)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Melatonin 5 mg', 'type': 'DRUG', 'description': 'Group I: (5 mg melatonin): Participants will receive 5 mg of oral melatonin 1 hours before the cesarean section.', 'armGroupLabels': ['Group I: (5 mg melatonin)']}, {'name': 'Melatonin 10 mg', 'type': 'DRUG', 'description': 'Group II: (10 mg melatonin): Participants will receive 10 mg of oral melatonin 1 hours before the cesarean section.', 'armGroupLabels': ['Group II: (10 mg melatonin)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Group III: (Placebo): Participants will receive an identical placebo tablet 1 hours before the cesarean section.', 'armGroupLabels': ['Group III: (Placebo)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banhā', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Taghreed Sakr, MD degree of anesthesia', 'role': 'CONTACT', 'email': 'taghreed.sakr@fmed.bu.edu.eg', 'phone': '00201112723187'}], 'facility': 'Benha University Hospital', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anesthesia', 'investigatorFullName': 'Taghreed Elshahat Sakr', 'investigatorAffiliation': 'Benha University'}}}}