Tapentadol vs Tramadol in Total Knee Arthroplasty
- Conditions
- Total Knee ReplacementPost-operative PainChronic Pain
- Interventions
- Registration Number
- NCT06269770
- Lead Sponsor
- University of Thessaly
- Brief Summary
Compare the effectiveness of tapentadol and tramadol as part of a multimodal analgesia treatment for Total Knee Replacement (TKR).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- Patients for elective TKR
- ASA PS I - III
- Patient refusal
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tramadol Tramadol Tramadol will be administered in a multimodal analgesic approach to manage postoperative pain. Tapentadol Tapentadol Tapentadol will be administered in a multimodal analgesic approach to manage postoperative pain.
- Primary Outcome Measures
Name Time Method Post-operative pain 3rd postoperative day Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
- Secondary Outcome Measures
Name Time Method Outcome 6 weeks after surgery Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100)
Pain severity 6 weeks after surgery Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (0-96) \[The higher the score the higher the disability due to osteoarthritis\]
Neuropathic pain 6 months after surgery PainDETECT (0-35)
Post-operative pain 6 months after surgery Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Patient Satisfaction 5 days after surgery at Discharge 5-point Likert scale (0-5) \[5 representing higher satisfaction\]
Depression 5 days after surgery at Discharge Patient Health Questionnaire 9 (PHQ9) (0-27) \[The higher the score, more severe the depression\]
Function 6 weeks after surgery Oxford Knee Score (OKS) (0-48)
Arthritis impact 6 weeks after surgery ARTHRITIS IMPACT MEASUREMENT SCALES 2 Short Form (AIMS2-SF) (5Likert scale
Health Status 6 weeks after surgery 5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) \[The higher the score, the worse the health status\]
Quality of life postoperatively 6 months after surgery Patient Quality 15 (0-150)
Trial Locations
- Locations (1)
University Hospital Of Larissa
🇬🇷Larissa, Thessaly, Greece