Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
96 participants
INTERVENTIONAL
2023-05-01
2025-06-01
Brief Summary
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Detailed Description
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Postoperative pain is associated with longer hospital stays, lower satisfaction, increased opioid consumption, and transition to chronic pain. In TKR, the risk of chronic pain can be as high as 20%.
A suggested method of anesthesia and pain relief is the use of spinal anesthesia along with multimodal analgesia that includes an adductor canal block.
In our hospital, the multimodal analgesia protocol consists of intraoperative sedation with dexmedetomidine, a low dose of ketamine, paracetamol, NSAIDs, and magnesium. Dexamethasone and droperidol are preferred as antiemetics as they can improve the analgesic outcome.
To minimize the use of opioids, the administration of tramadol used to be the standard of care. Tapentadol is an opioid that can be equally effective in the treatment of postoperative pain and reduces the incidence of chronic pain after TKR.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tramadol
Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain.
Tramadol
Add tramadol, for effective pain management in a multimodal setting during TKR.
Tapentadol
Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain.
Tapentadol
Add tapentadol, for effective pain management in a multimodal setting during TKR.
Interventions
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Tapentadol
Add tapentadol, for effective pain management in a multimodal setting during TKR.
Tramadol
Add tramadol, for effective pain management in a multimodal setting during TKR.
Eligibility Criteria
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Inclusion Criteria
* ASA PS I - III
Exclusion Criteria
* Cognitive disfunction
* Severe psychiatric disease
* Under medication with MAO inhibitors, tricyclic antidepressants, serotonin reuptake inhibitors
* Not speaking Greek
* Known allergy to the study drugs
* Contraindications for any of the study drugs
* Chronic renal failure (GFR \< 50 ml/h)
* Liver failure
* Known regular use or misuse of opioids
* Pregnant women
* Patients undergoing general anesthesia
18 Years
80 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
Responsible Party
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Elena Arnaoutoglou
Professor in Anesthesiology
Principal Investigators
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Eleni Arnaoutolglou, MD, PhD
Role: STUDY_CHAIR
Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
Metaxia Bareka, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly
Locations
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University Hospital Of Larissa
Larissa, Thessaly, Greece
Countries
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Central Contacts
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References
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Baratta JL, Gandhi K, Viscusi ER. Perioperative pain management for total knee arthroplasty. J Surg Orthop Adv. 2014 Spring;23(1):22-36. doi: 10.3113/jsoa.2014.0022.
Roulet L, Rollason V, Desmeules J, Piguet V. Tapentadol Versus Tramadol: A Narrative and Comparative Review of Their Pharmacological, Efficacy and Safety Profiles in Adult Patients. Drugs. 2021 Jul;81(11):1257-1272. doi: 10.1007/s40265-021-01515-z. Epub 2021 Jul 1.
Rian T, Skogvoll E, Hofstad J, Hovik L, Winther SB, Husby VS, Klaksvik J, Egeberg T, Sand K, Klepstad P, Wik TS. Tapentadol vs oxycodone for postoperative pain treatment the first 7 days after total knee arthroplasty: a randomized clinical trial. Pain. 2021 Feb 1;162(2):396-404. doi: 10.1097/j.pain.0000000000002026.
Other Identifiers
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Tapentadol
Identifier Type: -
Identifier Source: org_study_id
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