Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 9:20 PM
Study NCT ID:
NCT07169006
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Preoperative Gabapentin on Postoperative Pain Control and Analgesic Requirements Following Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Assuming an effect size of 0.5 for preoperative gabapentin, a sample of 51 patients in each group would be enough to detect such effect, if true, at 0.05 alpha error and 0.80 power of the test'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-09-05', 'studyFirstSubmitQcDate': '2025-09-05', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing pain score between the two groups during 1st postoperative 24 hours using visual analogue score (VAS', 'timeFrame': '24 hours postoperative', 'description': 'Comparing pain score between the two groups during 1st postoperative 24 hours using visual analogue score (VAS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery Analgesia']}, 'descriptionModule': {'briefSummary': 'The importance of bariatric anesthesia and analgesia research cannot be ignored as it can inform and improve the perioperative protocols for other patients with morbid obesity irrespective of the surgical procedures they are undergoing', 'detailedDescription': 'Among various postoperative complications, pain is the main adverse event experienced by patients. Good control of postoperative pain is an important factor for reducing early postoperative complications such as pulmonary embolism, deep vein thrombosis, ileus, and respiratory infections, and for decreasing length of stay, lowering costs, and increasing patient satisfaction'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* patients with American Society of Anesthesiologists physical status ASA I to III\n* both genders\n* Morbid obese scheduled for bariatric surgery\n\nExclusion Criteria:\n\n* patients with impaired liver or kidney disease\n* patients with history of hypersensitivity to gabapentin\n* patients with history of alcohol abuse, chronic pain or frequent use of analgesic\n* patients with uncontrolled medical disease'}, 'identificationModule': {'nctId': 'NCT07169006', 'briefTitle': 'The Effect of Preoperative Gabapentin on Postoperative Pain Control and Analgesic Requirements Following Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Effect of Preoperative Gabapentin on Postoperative Pain Control and Analgesic Requirements Following Bariatric Surgery', 'orgStudyIdInfo': {'id': 'MD326/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Will receive a single dose of gabapentin 300 mg preoperatively before standard general anesthesia', 'interventionNames': ['Drug: Group 1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 2', 'description': 'will receive a placebo before standard general anesthesia', 'interventionNames': ['Drug: Group 2']}], 'interventions': [{'name': 'Group 1', 'type': 'DRUG', 'otherNames': ['Gabapentin 300'], 'description': 'Will receive a single dose of gabapentin 300 mg preoperatively before standard general anesthesia', 'armGroupLabels': ['Group 1']}, {'name': 'Group 2', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'will receive a placebo before standard general anesthesia', 'armGroupLabels': ['Group 2']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}