Chronic Pain, Post-operative Pain, Total Knee Replacement
Conditions
Keywords
total knee replacement, post-operative pain, tramadol, tapentadol
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.
Interventions
DRUGTapentadol
Add tapentadol, for effective pain management in a multimodal setting during TKR.
DRUGTramadol
Add tramadol, for effective pain management in a multimodal setting during TKR.
Sponsors
University of Thessaly
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients for elective TKR * ASA PS I - III
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 6 hours after surgery | Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcome | 6 weeks after surgery | Knee Injury and Osteoarthritis Outcome Score (KOOS) (0-100) |
| Post-operative pain | 3 weeks after surgery | Visual Analogue Scale (VAS) score measures 0 to 10 (0=no pain, 10=the worst pain) |
| Neuropathic pain | 6 months after surgery | PainDETECT (0-35) |
| Quality of life postoperatively | 6 months after surgery | Patient Quality 15 (0-150) |
| 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 |
| Depression | 5 days after surgery at Discharge | Patient Health Questionnaire 9 (PHQ9) (0-27) \[The higher the score, more severe the depression\] |
| Health Status | 6 weeks after surgery | 5 level EuroQol 5 Dimensions 5 level Score (EQ-5D-5L) (0-100) \[The higher the score, the worse the health status\] |
| Pain severity | 6 weeks after surgery | Western Ontario and McMaster Universities Osteoarthritis (WOMAC) (0-96) \[The higher the score the higher the disability due to osteoarthritis\] |
| Patient Satisfaction | 5 days after surgery at Discharge | 5-point Likert scale (0-5) \[5 representing higher satisfaction\] |
Countries
Greece
Contacts
Primary ContactEleni Arnaoutoglou, MD, PhD
Backup ContactMetaxia Bareka, MD, PhD
Outcome results
None listed