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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Add tapentadol, for effective pain management in a multimodal setting during TKR.
Add tramadol, for effective pain management in a multimodal setting during TKR.
University Hospital Of Larissa
Larissa, Thessaly, Greece
RECRUITINGPost-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 6 hours after surgery
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 12 hours after surgery
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 1st postoperative day
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 2nd postoperative day
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 3rd postoperative day
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 3 weeks after surgery
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 6 weeks after surgery
Post-operative pain
Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain)
Time frame: 6 months after surgery
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Neuropathic pain
PainDETECT (0-35)
Time frame: 6 months after surgery
Quality of life postoperatively
Patient Quality 15 (0-150)
Time frame: 6 months after surgery
Patient Satisfaction
5-point Likert scale (0-5) \[5 representing higher satisfaction\]
Time frame: 5 days after surgery at Discharge
Depression
Patient Health Questionnaire 9 (PHQ9) (0-27) \[The higher the score, more severe the depression\]
Time frame: 5 days after surgery at Discharge
Function
Oxford Knee Score (OKS) (0-48)
Time frame: 6 weeks after surgery
Outcome
Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100)
Time frame: 6 weeks after surgery
Arthritis impact
ARTHRITIS IMPACT MEASUREMENT SCALES 2 Short Form (AIMS2-SF) (5Likert scale
Time frame: 6 weeks after surgery
Health Status
5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) \[The higher the score, the worse the health status\]
Time frame: 6 weeks after surgery
Pain severity
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (0-96) \[The higher the score the higher the disability due to osteoarthritis\]
Time frame: 6 weeks after surgery