A Trial Comparing Adductor Canal Catheter and Intraarticular Catheter Following Primary Total Knee Arthroplasty

Study Overview
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Brief Summary
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The study is a prospective randomized controlled trial comparing intraarticular catheters and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA).

Detailed Description
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The study is a prospective, randomized controlled clinical trial comparing two methods of postoperative analgesia following primary TKA. Eligible primary TKA patients must be ASA I - III and require less than 20 mg oxycodone daily (or its equivalent). Exclusion criteria are: allergy to anesthetics, contraindication to regional anesthesia, sensory/motor disorder involving operative limb, non-english speaking, ASA IV or greater, psychiatric or cognitive disorders, incarceration, renal insufficiency with Cr > 2.0 and hepatic failure. When patients agree to participate in the study the following data will be collected by the research staff: ASA physical status, age, height, weight, gender, quantitative opiate use, numeric pain score with visual descriptors, painDETECT score (form included), WOMAC score (form included) and baseline Pain Management Questionnaire. When designated through randomization, intra-articular catheters will be placed intraoperatively by the surgeons, per usual protocol. ACC's will be placed postoperatively in the PACU. The catheters will exit the bandage in a similar fashion to blind the personnel collecting data, postoperatively. Those collecting data will not be blinded from identifying patients in the control group, as no catheter will exit the bandage. Potential risks for each procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy. The preceding are commonly listed though infrequent complications of both procedures. Continuous ultrasound will guide the placement of the ACC.

Official Title
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A Randomized Controlled Trial Comparing the Adductor Canal Catheter (ACC) and Intra-articular Catheter (IAC) Following Primary Total Knee Arthroplasty

Conditions
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Acute Pain, Regional Anesthesia Morbidity

Intervention / Treatment
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* Procedure: Adductor Canal Catheter
* Procedure: Intraarticular Catheter
* Drug: Ropivicaine
* Drug: Bupivicaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-85 American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. Undergoing Unilateral, Primary, Total Knee Arthroplasty English as native language Exclusion Criteria: Patient refusal History of opioid dependence Contraindication to peripheral nerve block Pre-existing significant neuropathy

Ages Eligible for Study
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Minimum Age: 40 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 |
| --- | --- |
| Experimental: Adductor Canal Catheter<br>Postoperatively, patients will be brought to the PACU. The needle insertion site, approximately 10cm proximal to their operative knee, will be exposed. A sterile field will be utilized and the femoral artery is identified with a high frequency linear transducer proximal to the operative knee. 18g insulated Tuohy needle will be inserted in an out-of-plane approach through the sartorius muscle to a final location in close proximity to the saphenous nerve. Once satisfied with needle placement and following negative aspiration, 15 cc's of 0.5% ropivicaine will be injected through the needle under visualization. A 20-g multi-orifice catheter will be inserted approximately 4 cm beyond the needle tip and secured. | Procedure: Adductor Canal Catheter<br>* 0.5% Ropivicaine for primary block and 0.2% Ropivicaine infusion by OnQ Pump<br>Drug: Ropivicaine<br> <br> |
| Experimental: Intraarticular Catheter<br>Intra-articular catheters will be placed by the surgeon at the end of the procedure, before wound closure. A bupivacaine 0.5% infusion will be admin through the On-Q system and continued for 48 hours postoperatively. | Procedure: Intraarticular Catheter<br>* 0.5% Bupivicaine for primary block and 0.125% Bupivicaine infusion by OnQ Pump<br>Drug: Bupivicaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain | postoperative pain as measured by Visual Analog Scale at rest and with movement | immediately postoperative period to post-operative day # 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption | Opioid consumption within hospitalization | immediat postoperative period to postoperative day # 2 | 
| Chronic post-surgical pain | Assess post-surgical pain and function as measured by PainDetect and WOMAC questionnaires at 6-8 weeks post-operative compared to preoperative pain and function | 6-8 weeks post-operative | 
| Participation in Physical therapy | Physical therapy benchmarks such as active and passive range of motion | immediate postoperative period to postoperative day #2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adductor Canal Catheter, Intraarticular Catheter, Arthroplasty, Replacement, Knee