Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-17 @ 11:00 PM
Study NCT ID:
NCT05083793
Status:
UNKNOWN
Last Update Posted:
2021-10-19
First Post:
2021-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine 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'}]}, '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'care provider'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2021-10-06', 'lastUpdatePostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphia dose', 'timeFrame': '24 hour postoperative', 'description': 'the total amount of rescue morphine received by patients for 24h postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': '24 hour postoperative', 'description': 'post operative VAS score'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregabalin'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '15315511', 'type': 'BACKGROUND', 'citation': 'Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia. 2004;45 Suppl 6:13-8. doi: 10.1111/j.0013-9580.2004.455003.x.'}, {'pmid': '16205916', 'type': 'BACKGROUND', 'citation': 'Hindmarch I, Trick L, Ridout F. A double-blind, placebo- and positive-internal-controlled (alprazolam) investigation of the cognitive and psychomotor profile of pregabalin in healthy volunteers. Psychopharmacology (Berl). 2005 Dec;183(2):133-43. doi: 10.1007/s00213-005-0172-7. Epub 2005 Nov 9.'}, {'pmid': '27630927', 'type': 'BACKGROUND', 'citation': 'Sebastian B, Talikoti AT, Nelamangala K, Krishnamurthy D. Effect of Oral Pregabalin as Preemptive Analgesic in Patients Undergoing Lower Limb Orthopedic Surgeries under Spinal Anaesthesia. J Clin Diagn Res. 2016 Jul;10(7):UC01-4. doi: 10.7860/JCDR/2016/18854.8081. Epub 2016 Jul 1.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/15315511/', 'label': 'Pregabalin pharmacology and its relevance to clinical practice'}]}, 'descriptionModule': {'briefSummary': 'The effect of pregabalin on post-operative pain and opioid consumption in spine surgery, a prospective, randomized, controlled study', 'detailedDescription': 'Aim of the work:\n\nThe aim of our study is to compare the analgesic effect of pre-emptive oral pregabalin 150mg on acute postoperative pain and opioid consumption in spine surgery. Evaluated by visual analog scale (VAS)\n\nprimary outcome measure is the total amount of rescue morphine received by patients for 24h postoperatively.\n\nsecondary outcome measures include level of acute postoperative pain by VAS, and duration of hospital stay\n\nPatients and methods :\n\nThis study will be carried out after being approved from the Medical Research Ethical Committee, Faculty of Medicine, Assiut University, Assiut, Egypt, and after obtaining a written informed consents from all participating patients.\n\ninclusion criteria: This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery\n\nExclusion criteria : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* : This prospective randomized clinical study will include eighty patients with ASA I-II, aged 18-60 years scheduled for spine surgery\n\nExclusion Criteria:\n\n* : Excluded from the study are patients with known allergy to the study drugs, significant cardiac, respiratory, renal, CNS or hepatic disease, drug or alcohol abuse, pregnant women, patients refusing participation and psychiatric or mental illness that would interfere with perception and assessment of pain.'}, 'identificationModule': {'nctId': 'NCT05083793', 'briefTitle': 'the Effect of Pregabalin on Postoperative Pain and Opioid Consumption in Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effect of Pregabalin on Post-operative Pain and Opioid Consumption in Spine Surgery, a Prospective, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': '17101526'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'patients have spine surgery receive oral pregabalin 150 mg 1 hour before surgery', 'interventionNames': ['Drug: Pregabalin 150mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'patients will receive placebo 1 hour before surgery with a sip of water.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Pregabalin 150mg', 'type': 'DRUG', 'otherNames': ['Pregabalin'], 'description': 'The effect of pregabalin on post-operative pain', 'armGroupLabels': ['Study group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'patients will receive placebo one hour before operation', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11174', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Mahmoud Maher', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mahmoud Maher, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University Hospitals'}]}, 'ipdSharingStatementModule': {'url': 'https://pubmed.ncbi.nlm.nih.gov/15315511/', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'one year', 'ipdSharing': 'YES', 'description': 'make individual participant data (IPD) available to other researchers', 'accessCriteria': 'Study protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of anesthesia and intensive care', 'investigatorFullName': 'Mohamed galal aly', 'investigatorAffiliation': 'Assiut University'}}}}