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NCT03482492 Clinical Trial

Tramadol vs.Tramadol With Paracetamol

Lumbar Disc Herniation Clinical Trial

Official title:
Comparison of Tramadol vs. Tramadol With Paracetamol for Efficacy of Postoperative Pain Management in Lumbar Discectomy: A Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03482492
Other study ID # 11.03.2014-397
Secondary ID
Status Completed
Phase N/A
First received March 20, 2018
Last updated March 27, 2018
Start date March 20, 2014
Est. completion date April 3, 2015

Study information
Verified date March 2018
Source Yeditepe University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 3, 2015
Est. primary completion date January 12, 2015
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tramadol
Tramadol iv
• Paracetamol
Paracetamol iv

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Yeditepe University Hospital

References & Publications (18)

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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. Review. — View 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. — View 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. — View 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. — View 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. — View 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. Epub 2005 Jan 28. Review. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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

White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005 Nov;101(5 Suppl):S5-22. Review. — View 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Severity of pain Self reported pain intensity 2 hours
Secondary Tramadol consumption Total tramadol consumption during time frame 2 hours
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