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

Primary Purpose

Acute Pain, Regional Anesthesia Morbidity

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Adductor Canal Catheter
Intraarticular Catheter
Ropivicaine
Bupivicaine
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Adductor Canal Catheter, Intraarticular Catheter, Arthroplasty, Replacement, Knee

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Adductor Canal Catheter

    Intraarticular Catheter

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Post-operative pain
    postoperative pain as measured by Visual Analog Scale at rest and with movement

    Secondary Outcome Measures

    Postoperative opioid consumption
    Opioid consumption within hospitalization
    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
    Participation in Physical therapy
    Physical therapy benchmarks such as active and passive range of motion

    Full Information

    First Posted
    April 29, 2015
    Last Updated
    October 22, 2015
    Sponsor
    Thomas Jefferson University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02497911
    Brief Title
    A Trial Comparing Adductor Canal Catheter and Intraarticular Catheter Following Primary Total Knee Arthroplasty
    Official Title
    A Randomized Controlled Trial Comparing the Adductor Canal Catheter (ACC) and Intra-articular Catheter (IAC) Following Primary Total Knee Arthroplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    November 2015 (Anticipated)
    Study Completion Date
    November 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Thomas Jefferson University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Pain, Regional Anesthesia Morbidity
    Keywords
    Adductor Canal Catheter, Intraarticular Catheter, Arthroplasty, Replacement, Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Adductor Canal Catheter
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Intraarticular Catheter
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Adductor Canal Catheter
    Intervention Description
    0.5% Ropivicaine for primary block and 0.2% Ropivicaine infusion by OnQ Pump
    Intervention Type
    Procedure
    Intervention Name(s)
    Intraarticular Catheter
    Intervention Description
    0.5% Bupivicaine for primary block and 0.125% Bupivicaine infusion by OnQ Pump
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivicaine
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivicaine
    Primary Outcome Measure Information:
    Title
    Post-operative pain
    Description
    postoperative pain as measured by Visual Analog Scale at rest and with movement
    Time Frame
    immediately postoperative period to post-operative day # 2
    Secondary Outcome Measure Information:
    Title
    Postoperative opioid consumption
    Description
    Opioid consumption within hospitalization
    Time Frame
    immediat postoperative period to postoperative day # 2
    Title
    Chronic post-surgical pain
    Description
    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
    Time Frame
    6-8 weeks post-operative
    Title
    Participation in Physical therapy
    Description
    Physical therapy benchmarks such as active and passive range of motion
    Time Frame
    immediate postoperative period to postoperative day #2

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jaime L Baratta, MD
    Organizational Affiliation
    Sidney Kimmel Medical Center at Thomas Jefferson University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18627367
    Citation
    Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.
    Results Reference
    background
    PubMed Identifier
    21394001
    Citation
    Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.
    Results Reference
    background
    PubMed Identifier
    22221014
    Citation
    Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
    Results Reference
    background
    PubMed Identifier
    20571832
    Citation
    Kazak Bengisun Z, Aysu Salviz E, Darcin K, Suer H, Ates Y. Intraarticular levobupivacaine or bupivacaine administration decreases pain scores and provides a better recovery after total knee arthroplasty. J Anesth. 2010 Oct;24(5):694-9. doi: 10.1007/s00540-010-0970-x. Epub 2010 Jun 23.
    Results Reference
    background
    PubMed Identifier
    21821506
    Citation
    Essving P, Axelsson K, Aberg E, Spannar H, Gupta A, Lundin A. Local infiltration analgesia versus intrathecal morphine for postoperative pain management after total knee arthroplasty: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):926-33. doi: 10.1213/ANE.0b013e3182288deb. Epub 2011 Aug 4.
    Results Reference
    background

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

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