Postoperative Analgesia After Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization. The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.

Official Title
-----------------
Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion

Conditions
-----------------
Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Drug: Ropivacaine, Ketorolac, adrenaline
* Drug: Ropivacaine Ketorolac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted consecutively to primary total knee arthroplasty. Provided informed consent Exclusion Criteria: Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception Severe chronic neurogenic pain Medical treated diabetes Contraindications for spinal aesthesia and epidural analgesia Known hypersensitivity towards study drugs Rheumatoid arthritis Treatment with narcotics Treatment with antidepressants Severe obesity BMI>35 Treatment with antacid Not able to speak and understand Danish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Ropivacaine, Ketorolac, adrenaline<br>* Infiltration: 150 ml Ropivacaine 2mg/ml added 1 ml Ketorolac 30 mg/ml and 0,5 ml Adrenaline 1 mg/ml Intraarticular infusion: 4 ml/h 384 mg Ropivacaine 60 mg Ketorolac<br>|
| Active Comparator: 2<br> | Drug: Ropivacaine Ketorolac<br>* Epidural infusion: 4 ml/h 384 mg Ropivacaine I.V. Ketorolac 90 mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgésia consumption |  | 48 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to discharge |  |  | 
| Cytokine level |  | 48 h | 
| Pain scores VAS |  | 72 h | 
| Side-effects |  | 72 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative pain