The study is a prospective randomized controlled trial comparing local infiltration of analgesia in the knee joint and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA).
Full Title of Study: “A Double-Blinded Randomized Controlled Trial Comparing the Adductor Canal Catheter (ACC) and Local Infiltration of Analgesia (LIA) Following Primary Total Knee Arthroplasty”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Care Provider)
- Study Primary Completion Date: October 2016
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, WOMAC score and baseline Pain Management Questionnaire. When designated through randomization, local infiltration of analgesia will be placed intraoperatively by the surgeons, per usual protocol and patients in the LIA group will receive sham adductor canal catheter. All ACC's for both study groups will be placed postoperatively in the PACU. Those collecting data will be blinded from identifying patients in the control group, as both groups will have ACC placed with same technique. 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. All adductor canal catheters will remain in for 72 hours. Pt from LIA group will be discharged home with sham catheter with a saline infusion at 10 ml/hr via an ambulatory pump. Patients in ACC group will be discharged with continuous adductor canal catheter delivering ropivacaine 0.2% at 10 ml/hr via an ambulatory pump. Patients will be called daily for pain diary results. As well as at 6-8 weeks postoperatively to collect painDetect and WOMAC survey.
- Drug: ropivacaine
- 15 ml 0.5% Ropivicaine for primary adductor canal block under ultrasound guidance and 0.2% Ropivicaine infusion 10 ml/hr.
- Drug: bupivacaine
- 20 ml bupivacaine ( Marcaine 0.25% with epinephrine 1:200000, Hospira Inc. Lake Forest, IL) diluted with 40 ml of normal saline injected intraoperatively into the knee joint before closure.
- Device: Sham Adductor Canal Catheter
- Sham catheter placement via ultrasound-guided adductor canal block and 10ml/hr saline via OnQ Pump via continuous catheter in adductor canal.
- Device: Adductor Canal Catheter
- Catheter placed in adductor canal via ultrasound guidance and continuous infusion via OnQ pump.
Arms, Groups and Cohorts
- Experimental: Adductor Canal Catheter
- This group will receive ropivacaine 0.5% 15 ml for the adductor canal block under ultrasound guided nerve block. A multi-orifice catheter will be placed in the adductor canal and an infusion of ropivacaine 0.2% at 10 ml/hr will be continued for 72 hours.
- Experimental: Local Infiltration of Analgesia
- Local infiltration using 20 ml of free bupivacaine solution (Marcaine 0.25% with epinephrine 1:200000, ) diluted with 40 ml of normal saline following implantation of the knee prosthesis, the solution will be injected into the vastus medialis (5 ml), medial retinaculum (5 ml), origin of MCL (5 ml) and LCL (5 ml), lateral portion of quadriceps tendon (5 ml), vastus lateralis (5 ml), and subcutaneous tissues especially along saphenous nerve distribution (30 ml). Postoperatively, a sham adductor canal catheter will be placed as in the ACC arm following stabilization in the PACU to infuse only normal saline with an initial bolus of 15 ml saline and infusion of saline at 10ml/hr for 72 hours.
Clinical Trial Outcome Measures
- Post-operative pain via numeric rating scale at rest and with activity during each physical therapy session
- Time Frame: post-operative day #0 to post-operative day #3
- postoperative pain as measured by numeric rating scale at rest and with movement during each physical therapy session.
- Postoperative opioid consumption
- Time Frame: post-operative day #0 to postoperative day # 3
- Opioid consumption during hospitalization in oxycodone equivalents at 24, 48 and 72 hours
- Chronic post-surgical pain measured via validated painDetect and WOMAC questionnaires
- Time Frame: 6-8 weeks after surgical date
- 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
- Passive and Active Range of Motion during Physical Therapy
- Time Frame: POD #0 to postoperative day #2
- Assess quantitative passive and active range of motion during physical therapy as well as Timed up to Go (TUG) which is routine assessment during physical therapy.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 40 Years
Maximum Age: 85 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Thomas Jefferson University
- Provider of Information About this Clinical Study
- Principal Investigator: Jaime Baratta, Assistant Professor – Thomas Jefferson University
- Overall Official(s)
- Jaime L Baratta, MD, Principal Investigator, Thomas Jefferson University
- Overall Contact(s)
- Jaime L Baratta, MD, firstname.lastname@example.org
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