Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-02 @ 3:38 AM
Study NCT ID:
NCT04775992
Status:
UNKNOWN
Last Update Posted:
2021-03-01
First Post:
2021-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preemptive Analgesia of Gabapentoids in Orthopedic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-25', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-02-25', 'lastUpdatePostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain score on rest', 'timeFrame': 'every hour for the first 24 hours', 'description': 'Pain score by VAS on rest'}, {'measure': 'Postoperative pain during movement', 'timeFrame': 'every hour for the first 24 hours', 'description': 'Pain score by VAS during movements'}], 'secondaryOutcomes': [{'measure': 'Worst pain score', 'timeFrame': 'during the first 24 hours', 'description': 'Highest pain score'}, {'measure': 'Least pain score', 'timeFrame': 'during the first 24 hours', 'description': 'Lowest pain score'}, {'measure': 'Time spend in severe pain', 'timeFrame': 'during the first 24 hours', 'description': 'how many hours the patients complaint of severe pain'}, {'measure': "Patient's satisfaction", 'timeFrame': 'during the first 24 hours', 'description': 'Satisfaction by the quality of analgesia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acute postoperative pain', 'Preemptive analgesia', 'Orthopedic surgery', 'Preoperative gabapentoids'], 'conditions': ['Acute Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'To address the preemptive analgesic effect of preoperative gabapentoids versus no gabapentoids in orthopedic surgery', 'detailedDescription': 'Computer search for all studies used preoperative gabapentoids versus no gabapentoids in orthopedic surgery during the last 10 years (from 2011 - 2020)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all included RCT', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RCT, during last 10 years, involving orthopedic surgery\n\nExclusion Criteria:\n\n* non randomized trials, unavailable study data'}, 'identificationModule': {'nctId': 'NCT04775992', 'briefTitle': 'Preemptive Analgesia of Gabapentoids in Orthopedic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'Preemptive Analgesia of Gabapentoids After Major Orthopedic Surgery: Systematic Review and Meta Analysis', 'orgStudyIdInfo': {'id': 'KSU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'preemptive group', 'description': 'patients in this group will receive preoperative gabapentoids', 'interventionNames': ['Other: gabapentoids']}, {'label': 'control group', 'description': 'patients in this group will not receive gabapentoids', 'interventionNames': ['Other: gabapentoids']}], 'interventions': [{'name': 'gabapentoids', 'type': 'OTHER', 'description': 'Preemptive analgesia', 'armGroupLabels': ['control group', 'preemptive group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Consultant - Anesthesia and Pain Management', 'investigatorFullName': 'SALAH EL-TALLAWY', 'investigatorAffiliation': 'King Saud University'}}}}