Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty
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|ClinicalTrials.gov Identifier: NCT02603900|
Recruitment Status : Unknown
Verified November 2015 by Jaime Baratta, Thomas Jefferson University.
Recruitment status was: Recruiting
First Posted : November 13, 2015
Last Update Posted : November 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain Regional Anesthesia Morbidity||Drug: ropivacaine Drug: bupivacaine Device: Sham Adductor Canal Catheter Device: Adductor Canal Catheter||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Double-Blinded Randomized Controlled Trial Comparing the Adductor Canal Catheter (ACC) and Local Infiltration of Analgesia (LIA) Following Primary Total Knee Arthroplasty|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2016|
|Estimated Study Completion Date :||December 2016|
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.
15 ml 0.5% Ropivicaine for primary adductor canal block under ultrasound guidance and 0.2% Ropivicaine infusion 10 ml/hr.
Other Name: Naropin
Device: Adductor Canal Catheter
Catheter placed in adductor canal via ultrasound guidance and continuous infusion via OnQ pump.
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.
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.
Other Name: Marcaine
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603900
|Contact: Jaime L Baratta, MDfirstname.lastname@example.org|
|United States, Pennsylvania|
|Thomas Jefferson University Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Jaime L Baratta, MD||Thomas Jefferson University|