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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02497911
Recruitment Status : Unknown
Verified October 2015 by Jaime Baratta, Thomas Jefferson University.
Recruitment status was:  Enrolling by invitation
First Posted : July 15, 2015
Last Update Posted : October 23, 2015
Sponsor:
Information provided by (Responsible Party):
Jaime Baratta, Thomas Jefferson University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Acute Pain Regional Anesthesia Morbidity Procedure: Adductor Canal Catheter Procedure: Intraarticular Catheter Drug: Ropivicaine Drug: Bupivicaine 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 (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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Adductor Canal Catheter (ACC) and Intra-articular Catheter (IAC) Following Primary Total Knee Arthroplasty
Study Start Date : January 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Bupivacaine

Arm Intervention/treatment
Experimental: Adductor Canal Catheter
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
0.5% Ropivicaine for primary block and 0.2% Ropivicaine infusion by OnQ Pump

Drug: Ropivicaine
Experimental: Intraarticular Catheter
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
0.5% Bupivicaine for primary block and 0.125% Bupivicaine infusion by OnQ Pump

Drug: Bupivicaine



Primary Outcome Measures :
  1. Post-operative pain [ Time Frame: immediately postoperative period to post-operative day # 2 ]
    postoperative pain as measured by Visual Analog Scale at rest and with movement


Secondary Outcome Measures :
  1. Postoperative opioid consumption [ Time Frame: immediat postoperative period to postoperative day # 2 ]
    Opioid consumption within hospitalization

  2. Chronic post-surgical pain [ Time Frame: 6-8 weeks post-operative ]
    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. Participation in Physical therapy [ Time Frame: immediate postoperative period to postoperative day #2 ]
    Physical therapy benchmarks such as active and passive range of motion



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): NCT02497911


Sponsors and Collaborators
Thomas Jefferson University
Investigators
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Principal Investigator: Jaime L Baratta, MD Sidney Kimmel Medical Center at Thomas Jefferson University Hospital

Publications:

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Responsible Party: Jaime Baratta, Clinical Instructor, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02497911    
Other Study ID Numbers: 00002109
First Posted: July 15, 2015    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: October 2015
Keywords provided by Jaime Baratta, Thomas Jefferson University:
Adductor Canal Catheter
Intraarticular Catheter
Arthroplasty, Replacement, Knee
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents