Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-23 @ 12:14 AM
Study NCT ID:
NCT02724293
Status:
COMPLETED
Last Update Posted:
2016-03-31
First Post:
2016-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-30', 'studyFirstSubmitDate': '2016-03-25', 'studyFirstSubmitQcDate': '2016-03-30', 'lastUpdatePostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual analogue scale (VAS) score', 'timeFrame': '24 hours postoperatively', 'description': 'analgesic efficacy of study drugs as represented by the VAS score of the patients in the first 24 hours.'}, {'measure': 'postoperative opioid consumption', 'timeFrame': '24 hours postoperatively', 'description': 'ability of study drugs to reduce the postoperative opioid analgesic consumption.'}, {'measure': 'time to first request of opioid analgesia', 'timeFrame': '24 hours postoperatively', 'description': 'ability of the study drugs to delay the request of rescue opioid analgesia.'}], 'secondaryOutcomes': [{'measure': 'Safety assessed by incidence of side effects', 'timeFrame': '24 hours postoperatively', 'description': 'represented by the incidence of side effects during the follow up period of 24 hours.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain Following Radical Cystectomy']}, 'descriptionModule': {'briefSummary': 'This study compares analgesic efficacy, and safety of three different doses of peri-operative pregabaline to placebo following radical cystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sixty patients between the ages of 18 and 60 years.\n* American Society of Anesthesiologists (ASA) I-II physical status.\n* undergoing radical cystectomy under general anesthesia.\n\nExclusion Criteria:\n\n* Patients with a history of drug or alcohol abuse.\n* patients with chronic pain or daily intake of analgesics.\n* uncontrolled diabetes mellitus.\n* uncontrolled hypertension.\n* atherosclerotic heart disease.\n* seizures.\n* impaired kidney or liver functions,\n* patients with body mass index ≥35 kg/m2, and whom\n* patients that could not control a patient controlled analgesia (PCA) device.'}, 'identificationModule': {'nctId': 'NCT02724293', 'briefTitle': 'Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Analgesic Efficacy and Safety of Peri-operative Pregabalin Following Radical Cystectomy, a Prospective,Randomized, Double-blinded, Controlled Trial', 'orgStudyIdInfo': {'id': '266'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group I (placebo)', 'description': 'patients received placebo.', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (pregabaline 300 once)', 'description': 'patients received pregabalin 300 mg 2 hours preoperatively.', 'interventionNames': ['Drug: pregabaline 300 mg once.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III (pregabaline 300 twice)', 'description': 'patients received pregabalin 300 mg 2 hours preoperatively and 12 hours after the preoperative dose.', 'interventionNames': ['Drug: pregabaline 300 mg twice.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group IV (pregabaline 600)', 'description': 'patients received pregabalin 600 mg 2 hours preoperatively', 'interventionNames': ['Drug: pregabaline 600 mg once.']}], 'interventions': [{'name': 'pregabaline 300 mg once.', 'type': 'DRUG', 'description': 'patients received pregabaline 300 mg 2 hours pre-operatively.', 'armGroupLabels': ['Group II (pregabaline 300 once)']}, {'name': 'pregabaline 300 mg twice.', 'type': 'DRUG', 'description': 'patients received pregabaline 300 mg 2 hours pre-operatively, and 12 hours later.', 'armGroupLabels': ['Group III (pregabaline 300 twice)']}, {'name': 'pregabaline 600 mg once.', 'type': 'DRUG', 'description': 'patients received pregabaline 600 mg 2 hours pre-operatively.', 'armGroupLabels': ['Group IV (pregabaline 600)']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'patients received placebo', 'armGroupLabels': ['Group I (placebo)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia, icu, and pain management', 'investigatorFullName': 'Ahmad Mohammad Abd El-Rahman', 'investigatorAffiliation': 'Assiut University'}}}}