Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT01014520
Status:
UNKNOWN
Last Update Posted:
2009-11-17
First Post:
2009-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}], 'ancestors': [{'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'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D000639', 'term': 'Amitriptyline'}], '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'}, {'id': 'D003986', 'term': 'Dibenzocycloheptenes'}, {'id': 'D001567', 'term': 'Benzocycloheptenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2010-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-11-16', 'studyFirstSubmitDate': '2009-11-14', 'studyFirstSubmitQcDate': '2009-11-16', 'lastUpdatePostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30% reduction in opium consumption in either study arms compared to the placebo group', 'timeFrame': 'Within the first 24 hours after surgery'}], 'secondaryOutcomes': [{'measure': '30% reduction in pain according to visual analogue scale in either study arms compared to the placebo group', 'timeFrame': 'Within the first 24 hours after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lumbar', 'Diskectomy', 'Laminectomy'], 'conditions': ['Herniated Disc', 'Intervertebral Disc Displacement']}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that Gabapentin or Amitriptyline has no role in preemptive analgesia to reduce postoperative pain after lumbar diskectomies.', 'detailedDescription': "Pain suppression plays a decisive role in patients' satisfaction following lumbar diskectomies, as the psychological component of the pain is a major cause of treatment failure.\n\nControversy exists whether preemptive prescription of gabapentin, as a known contributor to reduce postoperative pain, has a role in patients undergoing laminectomy for lumbar diskectomy or spinal canal stenosis.The aim of this study is to test the efficacy of amitriptyline and gabapentin in this group of neurosurgical patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent\n* Age:18 to 60\n* Weight: 60 to 80 Kg\n* ASA Class: I,II\n* Concordant physical and imaging findings in favor of symptomatic lumbar disk herniation\n* Single level lumbar disk herniation unresponsive to medical treatment\n\nExclusion Criteria:\n\n* Previous consumption of Gabapentin or Amitriptyline\n* Known allergy to investigated drugs\n* Reluctant to sign informed consent\n* Previous history of intolerance to narcotics\n* Simultaneous lumbar diskectomy and a fusion technique\n* Known renal failure\n* Pregnancy\n* Contraindications to Amitriptyline or Gabapentin prescription\n* Unable to use PCA\n* Habitual use of alcohol or opium\n* History of analgesic consumption during the last 24hours'}, 'identificationModule': {'nctId': 'NCT01014520', 'briefTitle': 'Efficacy of Gabapentin or Amitriptyline to Reduce Postoperative Pain After Lumbar Laminectomy and Diskectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tabriz University'}, 'officialTitle': 'Comparative Effects of Single Dose Preemptive Gabapentin or Amitriptyline on Postoperative Pain and Opioid Consumption in Single Level Lumbar Laminectomy and Diskectomy: A Double Blind RCT With Placebo Control', 'orgStudyIdInfo': {'id': '883'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gabapentin', 'description': 'Neurontin', 'interventionNames': ['Drug: Gabapentin , Amitriptyline']}, {'type': 'EXPERIMENTAL', 'label': 'Amitriptyline', 'description': 'Elavil', 'interventionNames': ['Drug: Gabapentin , Amitriptyline']}], 'interventions': [{'name': 'Gabapentin , Amitriptyline', 'type': 'DRUG', 'otherNames': ['Neurontin', 'Elavil'], 'description': 'Capsule, 300 mg, oral, single dose 2 hours before surgery\n\nCapsule,300 mg containing 25 mg Amitriptyline, oral, single dose 2 hours before surgery', 'armGroupLabels': ['Amitriptyline', 'Gabapentin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5166614756', 'city': 'Tabriz', 'state': 'East Azerbayjan', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Dawood Aghamohammadi, MD', 'role': 'CONTACT', 'email': 'daghamohamadi@yahoo.com', 'phone': '+98 411 3347054', 'phoneExt': '1065'}, {'name': 'Payman Vahedi, MD', 'role': 'CONTACT', 'email': 'payman.vahedi@gmail.com', 'phone': '+98 411 3340830'}, {'name': 'Dawood Aghamohammadi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Payman Vahedi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tabriz University of Medical Sciences', 'geoPoint': {'lat': 38.08, 'lon': 46.2919}}], 'centralContacts': [{'name': 'Dawood Aghamohammadi, MD', 'role': 'CONTACT', 'email': 'daghamohamadi@yahoo.com', 'phone': '+98 411 3340830', 'phoneExt': '1065'}, {'name': 'Payman Vahedi, MD', 'role': 'CONTACT', 'email': 'payman.vahedi@gmail.com', 'phone': '+98 411 3340830'}], 'overallOfficials': [{'name': 'Dawood Aghamohammadi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tabriz University'}, {'name': 'Payman Vahedi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tabriz University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tabriz University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Tabriz University', 'oldOrganization': 'Tabriz University'}}}}