Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:08 PM
Study NCT ID:
NCT07389551
Status:
COMPLETED
Last Update Posted:
2026-02-05
First Post:
2026-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-29', 'studyFirstSubmitDate': '2026-01-29', 'studyFirstSubmitQcDate': '2026-01-29', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain severity', 'timeFrame': '24 hours', 'description': 'The severity of pain was analyzed on the visual analogue scale (VAS), with a lower score labelling the effectiveness of the treatment.'}, {'measure': 'Analgesia duration', 'timeFrame': '24 hours', 'description': 'The duration of analgesia was measured from awakening to the need of rescue analgesia, when a pain score was more than 3 on VAS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthopedic Surgery']}, 'descriptionModule': {'briefSummary': 'There are extensive gaps in the local data considering pregabalin versus gabapentin as pre-emptive analgesics in patients undergoing orthopedic surgeries under spinal anesthesia. Therefore, the current study was planned with the objective of comparing pregabalin versus gabapentin as pre-emptive analgesics in patients undergoing orthopedic surgeries under spinal anesthesia.', 'detailedDescription': 'Since postoperative pain in orthopedic surgery, whether neuropathic or nociceptive, presents a significant challenge for both surgeons and patients, knowing the more effective gabapentinoid as a pre-emptive analgesic would help clinicians to offer prolonged timing of first rescue analgesia and less opioid consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either gender\n* Aged 20-60 years\n* Undergoing lower limb orthopedic surgeries under spinal anesthesia\n\nExclusion Criteria:\n\n* Patients with a previous history of spine interventions, including surgery or injections (transforaminal, epidural, or facetal) for pain relief\n* Patients under any sort of pain modulation therapy, like transcutaneous electrical nerve stimulation\n* Patients had a long-term history of any analgesia use\n* Those with psychiatric disorders, alcohol/drug dependence, hepatic, renal, cardiac, or pulmonary abnormalities,\n* With a history of allergies to gabapentinoids'}, 'identificationModule': {'nctId': 'NCT07389551', 'briefTitle': 'Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic in Patients Undergoing Orthopedic Surgeries Under Spinal Anesthesia', 'orgStudyIdInfo': {'id': 'Dr-Usman-QAMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group-G', 'description': 'Patients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia.', 'interventionNames': ['Drug: Gabapentin']}, {'type': 'EXPERIMENTAL', 'label': 'Group-P', 'description': 'Patients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia', 'interventionNames': ['Drug: Pregabalin']}], 'interventions': [{'name': 'Gabapentin', 'type': 'DRUG', 'description': 'Patients were given a single oral dose of gabapentin 300 mg, with 30 ml of water, one hour prior to administration of spinal anesthesia.', 'armGroupLabels': ['Group-G']}, {'name': 'Pregabalin', 'type': 'DRUG', 'description': 'Patients received pregabalin 150 mg as a single oral dose, with 30 ml of water, one hour prior to administration of spinal anesthesia.', 'armGroupLabels': ['Group-P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Bahawalpur', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Victoria Hospital/Qaid-e-Azam Medical College', 'geoPoint': {'lat': 29.39779, 'lon': 71.6752}}], 'overallOfficials': [{'name': 'Muhammad Usman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur'}, {'name': 'Ambreen Khan, FCPS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bahawal Victoria Hospital/Quid-e-Azam Medical College, Bahawalpur'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be shared on a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}