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Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR).
As the population ages and becomes more active, the demand for TKR surgery is expected to increase. However, the treatment of TKR pain remains a challenge.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol | Active Comparator | Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain. |
|
| Tapentadol | Active Comparator | Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tapentadol | Drug | Add tapentadol, for effective pain management in a multimodal setting during TKR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain) | 6 hours after surgery |
| Post-operative pain | Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain) | 12 hours after surgery |
| Post-operative pain | Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain) | 1st postoperative day |
| Post-operative pain | Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain) | 2nd postoperative day |
| Post-operative pain | Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain) | 3rd postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative pain | Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain) | 3 weeks after surgery |
| Post-operative pain | Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eleni Arnaoutoglou, MD, PhD | Contact | 00302413502952 | earnaout@gmail.com | |
| Metaxia Bareka, MD, PhD | Contact | +306947845083 | barekametaxia@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eleni Arnaoutolglou, MD, PhD | Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly | Study Chair |
| Metaxia Bareka, MD, PhD | Department of Anesthesiology, Faculty of Medicine, School of Health Sciences, University of Thessaly |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Of Larissa | Recruiting | Larissa | Thessaly | 41110 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24641894 | Background | 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. | |
| 34196947 | Background | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077432 | Tapentadol |
| D014147 | Tramadol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Tramadol | Drug | Add tramadol, for effective pain management in a multimodal setting during TKR. |
|
| 6 weeks after surgery |
| Post-operative pain | Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain) | 6 months after surgery |
| Neuropathic pain | PainDETECT (0-35) | 6 months after surgery |
| Quality of life postoperatively | Patient Quality 15 (0-150) | 6 months after surgery |
| Patient Satisfaction | 5-point Likert scale (0-5) [5 representing higher satisfaction] | 5 days after surgery at Discharge |
| Depression | Patient Health Questionnaire 9 (PHQ9) (0-27) [The higher the score, more severe the depression] | 5 days after surgery at Discharge |
| Function | Oxford Knee Score (OKS) (0-48) | 6 weeks after surgery |
| Outcome | Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100) | 6 weeks after surgery |
| Arthritis impact | ARTHRITIS IMPACT MEASUREMENT SCALES 2 Short Form (AIMS2-SF) (5Likert scale | 6 weeks after surgery |
| Health Status | 5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) [The higher the score, the worse the health status] | 6 weeks after surgery |
| Pain severity | Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (0-96) [The higher the score the higher the disability due to osteoarthritis] | 6 weeks after surgery |
| Principal Investigator |
| 32773594 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |