Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-31 @ 2:35 AM
Study NCT ID:
NCT04653792
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2020-11-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-03', 'studyFirstSubmitDate': '2020-11-27', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change from preoperative pain score using a 10 point visual analog scale (VAS pain scale) at 1 week post surgery for PID', 'timeFrame': 'Preoperative and one week postoperative', 'description': 'VAS pain scale is a validated, self-reported instrument assessing average pain intensity over the past 24 hours period. Possible scores being 0 (no pain) and 10 (worst possible pain). Change = (1 week post surgery - preoperative pain)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Microdiscectomy', 'Pregabalin'], 'conditions': ['Pain, Nerve', 'Prolapsed Intervertebral Disc']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the effect of pregabalin in reducing the neuropathic pain in postoperative patients who have undergone single level Microdiscectomy for prolapsed intervetebral lumbar disc.', 'detailedDescription': 'All patients were informed in detailed regarding the risk and complications and given written and informed consent, coming to our clinics were assessed by one of the senior team members of the spine, patient fulfilling the eligibility criteria were selected and included in the study. One week before the surgery the patients who met the eligibility criteria were randomized in a double-blind manner (participant and investigator) in a ratio of 1:1 into Group-A (Pregabalin 7mg, twice daily) or Group-B (Placebo, twice daily). The pain scores were recorded by VAS and Roland Morris score system on preoperative day compared to the scores on the 1st week postoperative follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with severe CLBP and/or leg pain\n* Patients with static or dynamic leg pain\n* Patients with leg pain resulting from localized lumbar or lumbosacral segmental instability\n* Spinal stenosis at levels L2-S1 or caused by isthmic spondylolisthesis (grade I and II)\n\nExclusion Criteria:\n\n* Patients with previous lumbar surgery\n* Patients allergic to gabapentinoids\n* Patients with renal impairments\n* Patients who are already on opioids, benzodiazepines, barbiturates, ethanol (alcohol)\n* Patient presented with diabetes and other drugs that depress the central nervous system\n* Patients who are already on ACE inhibitors as they may enhance the adverse/toxic effect of Pregabalin.'}, 'identificationModule': {'nctId': 'NCT04653792', 'briefTitle': 'Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ziauddin University'}, 'officialTitle': 'Role Of Pregabalin To Decrease Postoperative Pain In Microdiscectomy: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'preg2020micro'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pregabalin', 'description': 'Participants received Pregabalin 75mg capsule twice daily from preoperative day to 1 week postoperative', 'interventionNames': ['Drug: Pregabalin 75mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Pregabalin Placebo', 'description': 'Participants received Pregabalin placebo capsule matching Pregabalin twice daily from preoperative day to 1 week postoperative', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': 'Pregabalin 75mg', 'type': 'DRUG', 'otherNames': ['Lyrica (Pregabalin) 75mg'], 'description': '75 mg capsule', 'armGroupLabels': ['Pregabalin']}, {'name': 'Placebo', 'type': 'DEVICE', 'otherNames': ['Pregabalin placebo'], 'description': '75 mg', 'armGroupLabels': ['Pregabalin Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75600', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Dr. Ziauddin University Hospital Clifton Campus', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Shahzaib Riaz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University hospital Karachi'}, {'name': 'Sohail Rafi, FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ziauddin University Hospital Karachi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziauddin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Resident, Orthopedics Department', 'investigatorFullName': 'Shahzaib Riaz Baloch', 'investigatorAffiliation': 'Ziauddin University'}}}}