Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-02-27 @ 11:20 PM
Study NCT ID:
NCT05071118
Status:
COMPLETED
Last Update Posted:
2021-10-08
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Pregabalin on the Duration of the Spinal Anesthesia and the Early Postoperative Pain After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2021-09-20', 'studyFirstSubmitQcDate': '2021-09-27', 'lastUpdatePostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'onset of spinal anaesthesia', 'timeFrame': 'three months', 'description': 'seventy participants undergoing elective total knee arthroplasty under spinal anesthesia half of them took placebo and the other half took 150 mg pregabalin two hours before the procedure and calculate the time from the base line to the onset of anesthesia.\n\nOur primary outcome is to assess the onset of spinal anesthesia.\n\nto detect the onset of spinal anaesthesia'}], 'secondaryOutcomes': [{'measure': 'recovery time', 'timeFrame': 'three months', 'description': 'Recovery time from the sensory blockade (2-dermatome regression of anesthesia from the maximum level).'}, {'measure': 'motor block duration', 'timeFrame': 'three months', 'description': 'the time for return to Bromag 2 (the patient is able to move knees and ankles).'}, {'measure': 'postoperative analgesia', 'timeFrame': 'three months.', 'description': '• Postoperative pain will be assessed by the patient using the visual analog scale in the first 24 hour(VAS, 0=no pain; 10=worst possible pain) every 2 hours up to 24 hours after the operation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'the purpose of this study is to evaluate the effectiveness of administration of pregabalin 2 hours preoperatively on the onset and the duration of the spinal anesthesia in total knee arthroplasty and the role of pregabalin in postoperative analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the ages of 40 and 70 years\n* height 155-170 cm\n* American Society of Anesthesiologists grade I or II .\n* patients underwent total knee arthroplasty under spinal anesthesia\n\nExclusion Criteria:\n\n* patients known to be allergic to any medicines.\n* patients had a history of drug or alcohol abuse.\n* patients were taking opioids or sedative medications,\n* patients Inability to communicate with investigators to evaluate the postoperative pain\n* patients were in need for postoperative ICU hospitalization .\n* patients had a history of psychiatric conditions.\n* Patients with a history of taking pregabalin or gabapentin .'}, 'identificationModule': {'nctId': 'NCT05071118', 'briefTitle': 'The Efficacy of Pregabalin on the Duration of the Spinal Anesthesia and the Early Postoperative Pain After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'the Effect of Adding Pregabalin on the Onset and the Duration of Spinal Anesthesia and on the Postoperative Analgesia', 'orgStudyIdInfo': {'id': 'FMASU R71/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'pregabalin group', 'description': 'Two hours before surgery, the pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery.', 'interventionNames': ['Drug: Pregabalin 150mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'placebo group', 'description': 'The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pregabalin 150mg', 'type': 'DRUG', 'description': 'pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery', 'armGroupLabels': ['pregabalin group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .', 'armGroupLabels': ['placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Ismail Mohammed', 'investigatorAffiliation': 'Ain Shams University'}}}}