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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
Sponsor:
Information provided by (Responsible Party):
Jaime Baratta, Thomas Jefferson University

Brief Summary:
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).

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

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.
Drug: ropivacaine
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.
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Jaime L Baratta, MD jaime.baratta@jefferosn.edu

Locations
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United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Jaime L Baratta, MD Thomas Jefferson University
Publications:

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Responsible Party: Jaime Baratta, Assistant Professor, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02603900    
Other Study ID Numbers: 15D.490
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 26, 2015
Last Verified: November 2015
Keywords provided by Jaime Baratta, Thomas Jefferson University:
Adductor Canal Catheter
Arthroplasty, Replacement, Knee
Local infiltration of analgesia
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents