Postoperative Pain Management After Total Knee Arthroplasty

Study Overview
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Brief Summary
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The study compares three different analgesic techniques in order to determine which one serves as the optimal method for postoperative pain management after Total Knee Arthroplasty in patients suffering from Osteoarthritis

Detailed Description
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Prospective, randomized, controlled study. Approval of the study from the University Hospital of Patras Ethics Committee. The Total Knee Arthroplasty procedure is performed always from the same team of Orthopedic surgeons who follow the same technique in each patient for the arthroplasty and the placement of the intraarticular catheter as well. The same team of Anesthesiologists (two Anesthesiologists) performs always the same technique for each analgesic method and is responsible for the patients' perioperative condition concerning anesthesia and analgesia. Preoperatively, one hour prior to the surgery, all patients receive preemptive multimodal analgesia in the following way; 40mg Parecoxib (iv), 1gr Paracetamol (iv), 150mg Pregabalin (po), 8mg Dexamethasone (iv) και 50mg Ranitidine (iv). All patients receive subarachnoid anesthesia with Ropivacaine 0.75% (7,5mg/ml) in a dosage of 2-3ml titrated according to patient's age and height. Three groups Continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg. Continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg. Continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg. All the catheters remain for 48 hours while the infusion rate is 2ml/h + PCA with 0,5ml/15min and lock-out maximum dose 4/h in total volume of 150ml. Postoperatively all patients also receive; Parecoxib, Paracetamol, Pregabalin, and Ranitidine up to the third postoperative day (doses titrated). Rescue analgesia: Tramadol Chloride 50-100mg x 2 /24h depending on patient's age and medical history.

Official Title
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Comparison Study of Three Different Methods of Postoperative Pain Management After Total Knee Arthroplasty

Conditions
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Postoperative Pain, Knee Arthroplasty

Intervention / Treatment
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* Procedure: Epidural analgesia - Group E
* Procedure: Femoral blockade - Group F
* Procedure: Intraarticular infusion - Group I


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for unilateral total knee arthroplasty (TKA) to treat knee osteoarthritis (OA) Fully conversant in the Greek language Written informed consent to participate in the trial Exclusion Criteria: Age less than 50 years and greater than 85 years. ASA score >III Pregnancy Subarachnoid anesthesia failure Hypersensitivity/ allergy to certain agent used Participation in other research/ study Severe mental disease (schizophrenia, major depression, severe bipolar disorder, substance abuse)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group E- Epidural analgesia<br>Continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure. The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The epidural catheter is placed preoperatively. | Procedure: Epidural analgesia - Group E<br>* Postoperative analgesia with continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)<br>|
| Active Comparator: Group F- Femoral blockade<br>Continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure.The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The femoral catheter is placed preoperatively. | Procedure: Femoral blockade - Group F<br>* Postoperative analgesia with continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min) .<br>|
| Active Comparator: Group I- Intraarticular infusion<br>Continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure.The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The intraarticular catheter is placed before the closure of the incision. | Procedure: Intraarticular infusion - Group I<br>* Postoperative analgesia with continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesia | Pain scores, during rest and movement (active and passive) according to NRS (Numeric Rating Scale) right after the end of the surgery and 2, 4, 6, 12, 24, 36, 48, 60 and 72 hours later (postoperatively) | Up to 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobilization | Time of mobilization (standing, walking in room, walking out of room) | Up to 3 days | 
| LOS | Length of hospital stay | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural analgesia, intra-articular infusion analgesia;, femoral nerve block, total knee arthroplasty