Tramadol vs.Tramadol With Paracetamol

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ClinicalTrials.gov Identifier: NCT03482492

Recruitment Status : Completed

First Posted : March 29, 2018

Last Update Posted : March 29, 2018

Sponsor:

Information provided by (Responsible Party):

Neslihan Uztüre, Yeditepe University Hospital

Study Description

Brief Summary:

This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.

Condition or disease	Intervention/treatment	Phase
Lumbar Disc Herniation	Drug: Tramadol Drug: Paracetamol	Not Applicable

Detailed Description:

Background:

Despite 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.

Aims:

This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.

Study Design:

In 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.

Methods:

Severity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative period.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	Comparison of Tramadol vs. Tramadol With Paracetamol for Efficacy of Postoperative Pain Management in Lumbar Discectomy: A Randomised Controlled Trial
Actual Study Start Date :	March 20, 2014
Actual Primary Completion Date :	January 12, 2015
Actual Study Completion Date :	April 3, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Tramadol Group Tramadol patients received tramadol 1 mg kg-1 iv	Drug: Tramadol Tramadol iv
Active Comparator: Tramadol-Paracetamol 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	Drug: Tramadol Tramadol iv Drug: Paracetamol Paracetamol iv

Outcome Measures

Primary Outcome Measures :

Severity of pain [ Time Frame: 2 hours ]
Self reported pain intensity

Secondary Outcome Measures :

Tramadol consumption [ Time Frame: 2 hours ]
Total tramadol consumption during time frame

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

American Society of Anesthesiologists (ASA) 1 or 2 status patients with single level lumbar disc herniation.

Exclusion Criteria:

Patients 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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03482492

Sponsors and Collaborators

Yeditepe University Hospital

Investigators

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Principal Investigator:	Neslihan Uztüre, MD	Yeditepe University

More Information

Publications:

Beakley BD, Kaye AM, Kaye AD. Tramadol, Pharmacology, Side Effects, and Serotonin Syndrome: A Review. Pain Physician. 2015 Jul-Aug;18(4):395-400. Review.

Cakan T, Inan N, Culhaoglu S, Bakkal K, Başar 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.

Grundmann U, Wörnle 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.

Hernández-Palazón J, Tortosa JA, Martínez-Lage JF, Pérez-Flores D. Intravenous administration of propacetamol reduces morphine consumption after spinal fusion surgery. Anesth Analg. 2001 Jun;92(6):1473-6.

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.

Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. Review.

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.

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.

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.

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.

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. Epub 2005 Jan 28. Review.

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.

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.

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.

Walder B, Schafer M, Henzi I, Tramèr 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.

White PF. Multimodal analgesia: its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008 Jan;9(1):76-82. Review.

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. Review.

Zhang Q, Qian J, Zhu Y. Meta-Analysis on Microdiscectomy and Sequestrectomy for Lumbar Disc Herniation. J Invest Surg. 2015;28(4):225-9.

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Responsible Party:	Neslihan Uztüre, Principal Investigator, Yeditepe University Hospital
ClinicalTrials.gov Identifier:	NCT03482492
Other Study ID Numbers:	11.03.2014-397
First Posted:	March 29, 2018 Key Record Dates
Last Update Posted:	March 29, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Neslihan Uztüre, Yeditepe University Hospital:


Acetaminophen Tramadol Discogenic pain Lumbar Discectomy

Additional relevant MeSH terms:

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Hernia Pathological Conditions, Anatomical Acetaminophen Tramadol Analgesics, Non-Narcotic Analgesics Sensory System Agents	Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Analgesics, Opioid Narcotics Central Nervous System Depressants

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