Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
Study NCT ID:
NCT03482492
Status:
COMPLETED
Last Update Posted:
2018-03-29
First Post:
2018-03-20
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tramadol vs.Tramadol With Paracetamol
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': 'D014147', 'term': 'Tramadol'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004123', 'term': 'Dimethylamines'}, {'id': 'D008744', 'term': 'Methylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2015-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-27', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-03-27', 'lastUpdatePostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of pain', 'timeFrame': '2 hours', 'description': 'Self reported pain intensity'}], 'secondaryOutcomes': [{'measure': 'Tramadol consumption', 'timeFrame': '2 hours', 'description': 'Total tramadol consumption during time frame'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acetaminophen', 'Tramadol', 'Discogenic pain', 'Lumbar Discectomy'], 'conditions': ['Lumbar Disc Herniation']}, 'referencesModule': {'references': [{'pmid': '26218943', 'type': 'BACKGROUND', 'citation': 'Beakley BD, Kaye AM, Kaye AD. Tramadol, Pharmacology, Side Effects, and Serotonin Syndrome: A Review. Pain Physician. 2015 Jul-Aug;18(4):395-400.'}, {'pmid': '18580346', 'type': 'BACKGROUND', 'citation': 'Cakan T, Inan N, Culhaoglu S, Bakkal K, Basar H. Intravenous paracetamol improves the quality of postoperative analgesia but does not decrease narcotic requirements. J Neurosurg Anesthesiol. 2008 Jul;20(3):169-73. doi: 10.1097/ANA.0b013e3181705cfb.'}, {'pmid': '16790656', 'type': 'BACKGROUND', 'citation': 'Grundmann U, Wornle C, Biedler A, Kreuer S, Wrobel M, Wilhelm W. The efficacy of the non-opioid analgesics parecoxib, paracetamol and metamizol for postoperative pain relief after lumbar microdiscectomy. Anesth Analg. 2006 Jul;103(1):217-22, table of contents. doi: 10.1213/01.ane.0000221438.08990.06.'}, {'pmid': '11375828', 'type': 'BACKGROUND', 'citation': 'Hernandez-Palazon J, Tortosa JA, Martinez-Lage JF, Perez-Flores D. Intravenous administration of propacetamol reduces morphine consumption after spinal fusion surgery. Anesth Analg. 2001 Jun;92(6):1473-6. doi: 10.1097/00000539-200106000-00024.'}, {'pmid': '18590407', 'type': 'BACKGROUND', 'citation': 'Jirarattanaphochai K, Jung S. Nonsteroidal antiinflammatory drugs for postoperative pain management after lumbar spine surgery: a meta-analysis of randomized controlled trials. J Neurosurg Spine. 2008 Jul;9(1):22-31. doi: 10.3171/SPI/2008/9/7/022.'}, {'pmid': '14667752', 'type': 'BACKGROUND', 'citation': 'Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.'}, {'pmid': '20173643', 'type': 'BACKGROUND', 'citation': 'Korkmaz Dilmen O, Tunali Y, Cakmakkaya OS, Yentur E, Tutuncu AC, Tureci E, Bahar M. Efficacy of intravenous paracetamol, metamizol and lornoxicam on postoperative pain and morphine consumption after lumbar disc surgery. Eur J Anaesthesiol. 2010 May;27(5):428-32. doi: 10.1097/EJA.0b013e32833731a4.'}, {'pmid': '19487950', 'type': 'BACKGROUND', 'citation': 'Ohnesorge H, Bein B, Hanss R, Francksen H, Mayer L, Scholz J, Tonner PH. Paracetamol versus metamizol in the treatment of postoperative pain after breast surgery: a randomized, controlled trial. Eur J Anaesthesiol. 2009 Aug;26(8):648-53. doi: 10.1097/EJA.0b013e328329b0fd.'}, {'pmid': '23672109', 'type': 'BACKGROUND', 'citation': 'Olonisakin RP, Amanor-Boadu SD, Akinyemi AO. Morphine-sparing effect of intravenous paracetamol for post operative pain management following gynaecological surgery. Afr J Med Med Sci. 2012 Dec;41(4):429-36.'}, {'pmid': '16580905', 'type': 'BACKGROUND', 'citation': 'Pickering G, Loriot MA, Libert F, Eschalier A, Beaune P, Dubray C. Analgesic effect of acetaminophen in humans: first evidence of a central serotonergic mechanism. Clin Pharmacol Ther. 2006 Apr;79(4):371-8. doi: 10.1016/j.clpt.2005.12.307.'}, {'pmid': '15681586', 'type': 'BACKGROUND', 'citation': 'Remy C, Marret E, Bonnet F. Effects of acetaminophen on morphine side-effects and consumption after major surgery: meta-analysis of randomized controlled trials. Br J Anaesth. 2005 Apr;94(4):505-13. doi: 10.1093/bja/aei085. Epub 2005 Jan 28.'}, {'pmid': '25187855', 'type': 'BACKGROUND', 'citation': 'Shimia M, Parish M, Abedini N. The effect of intravenous paracetamol on postoperative pain after lumbar discectomy. Asian Spine J. 2014 Aug;8(4):400-4. doi: 10.4184/asj.2014.8.4.400. Epub 2014 Aug 19.'}, {'pmid': '15791113', 'type': 'BACKGROUND', 'citation': 'Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005 Apr;102(4):822-31. doi: 10.1097/00000542-200504000-00019.'}, {'pmid': '20669107', 'type': 'BACKGROUND', 'citation': 'Uzun S, Aycan IO, Erden IA, Sahin A, Aypar U. The addition of metamizole to morphine and paracetamol improves early postoperative analgesia and patient satisfaction after lumbar disc surgery. Turk Neurosurg. 2010 Jul;20(3):341-7. doi: 10.5137/1019-5149.JTN.3081-10.3.'}, {'pmid': '11472277', 'type': 'BACKGROUND', 'citation': 'Walder B, Schafer M, Henzi I, Tramer MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand. 2001 Aug;45(7):795-804. doi: 10.1034/j.1399-6576.2001.045007795.x.'}, {'pmid': '18183534', 'type': 'BACKGROUND', 'citation': 'White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008 Jan;9(1):76-82.'}, {'pmid': '16334489', 'type': 'BACKGROUND', 'citation': 'White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005 Nov;101(5 Suppl):S5-S22. doi: 10.1213/01.ANE.0000177099.28914.A7.'}, {'pmid': '26268422', 'type': 'BACKGROUND', 'citation': 'Zhang Q, Qian J, Zhu Y. Meta-Analysis on Microdiscectomy and Sequestrectomy for Lumbar Disc Herniation. J Invest Surg. 2015;28(4):225-9. doi: 10.3109/08941939.2015.1006378.'}]}, 'descriptionModule': {'briefSummary': 'This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.', 'detailedDescription': 'Background:\n\nDespite developments in treatment of pain, the availability of new drugs or increased knowledge of pain management, postoperative pain control after different surgeries still remains inadequate.\n\nAims:\n\nThis study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.\n\nStudy Design:\n\nIn this study we have randomized 60 patients into two treatment groups. In Group Tramadol patients received tramadol, In Group TramadolParacetamol patients received paracetamol 1 gr iv in addition to tramadol 30 minutes before the operation ends and 1 g at 6 hour intervals.\n\nMethods:\n\nSeverity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAmerican Society of Anesthesiologists (ASA) 1 or 2 status patients with single level lumbar disc herniation.\n\nExclusion Criteria:\n\nPatients who could not use a patient controlled analgesia (PCA) device, known allergies to any of the drugs used in this study,hepatic and renal dysfunction, herniated disc with neurological deficit or intense pain justifying emergency surgery and the patients whose body mass index is ≥30 kg/m2 were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03482492', 'briefTitle': 'Tramadol vs.Tramadol With Paracetamol', 'organization': {'class': 'OTHER', 'fullName': 'Yeditepe University Hospital'}, 'officialTitle': 'Comparison of Tramadol vs. Tramadol With Paracetamol for Efficacy of Postoperative Pain Management in Lumbar Discectomy: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '11.03.2014-397'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol', 'description': 'Group Tramadol patients received tramadol 1 mg kg-1 iv', 'interventionNames': ['Drug: Tramadol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tramadol-Paracetamol', 'description': 'Group Tramadol-Paracetamol patients received paracetamol 1 gr iv in addition to tramadol 1 mg kg-1 iv 30 minutes before the end of the operation and after the operation at 6 hour intervals for 24 hours', 'interventionNames': ['Drug: Tramadol', 'Drug: Paracetamol']}], 'interventions': [{'name': 'Tramadol', 'type': 'DRUG', 'description': 'Tramadol iv', 'armGroupLabels': ['Tramadol', 'Tramadol-Paracetamol']}, {'name': 'Paracetamol', 'type': 'DRUG', 'description': 'Paracetamol iv', 'armGroupLabels': ['Tramadol-Paracetamol']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Neslihan Uztüre, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeditepe University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yeditepe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Neslihan Uztüre', 'investigatorAffiliation': 'Yeditepe University Hospital'}}}}