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Effects of Catheter Location Relative to Femoral Artery on Postoperative Analgesia for Continuous Adductor Canal Blocks

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Above Artery Catheter Placement
Between Artery and Vein Placement
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients undergoing unilateral total knee arthroplasty at UC San Diego with planned placement of an adductor canal catheter at request of surgeon

Exclusion Criteria:

  • history of allergic reaction to lidocaine or ropivacaine
  • history of peripheral neuropathy, neuropathic pain, or chronic pain requiring opioid medications.
  • Pregnant females and prisoners

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Above Artery Group

    Between Artery and Vein Group

    Arm Description

    Outcomes

    Primary Outcome Measures

    AVERAGE PAIN
    Average pain on post operative day 1 following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain).

    Secondary Outcome Measures

    Procedure duration
    Opioid consumption
    Distance Ambulated
    Worst pain score (NRS 0-10 reported by patient)
    Number of vascular pictures during placement
    Intravascular injection assessed by heart rate response to epinephrine in injection
    Total local anesthetic infused on first postoperative day

    Full Information

    First Posted
    August 22, 2018
    Last Updated
    August 24, 2018
    Sponsor
    University of California, San Diego
    Collaborators
    Rodney Gabriel MD, Matthew Swisher MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03650504
    Brief Title
    Effects of Catheter Location Relative to Femoral Artery on Postoperative Analgesia for Continuous Adductor Canal Blocks
    Official Title
    Effects of Catheter Location Relative to Femoral Artery on Postoperative Analgesia for Continuous Adductor Canal Blocks
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 24, 2018 (Anticipated)
    Primary Completion Date
    July 30, 2019 (Anticipated)
    Study Completion Date
    July 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, San Diego
    Collaborators
    Rodney Gabriel MD, Matthew Swisher MD

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Adductor canal (AC) nerve block is a commonly used modality for postoperative pain control after total knee arthroplasty (TKA). When the adductor canal is viewed by ultrasound, the femoral artery and femoral vein can easily be identified, however, the nerve that is to be blocked is often not visible. For this reason, the femoral artery is used as a landmark for the block. There currently are no studies examining the optimal placement of the nerve block catheter relative to the femoral artery in the canal. The goal of this study will be to examine the relationship between nerve catheter tip location relative to femoral artery within the adductor canal for continuous AC nerve blocks. The investigators specifically will compare postoperative pain as well as incidence of vascular puncture during the procedure and time to complete the procedure for two different catheter locations.
    Detailed Description
    This will be a single-center, randomized, controlled investigation. Consenting adults undergoing unilateral total knee arthroplasty with a planned adductor canal perineural catheter will be offered enrollment. Study inclusion will be proposed to eligible patients prior to surgery. If a patient desires study participation, written, informed consent will be obtained using a current UCSD IRB-approved ICF. Selection for inclusion will not be based on gender, race, or socioeconomic status. Following written, informed consent, we will record baseline anthropomorphic information. All subjects will have a peripheral intravenous (IV) catheter inserted, standard noninvasive monitors applied, supplemental oxygen administered via a nasal cannula or face mask, and positioned supine. Midazolam and fentanyl will be titrated for patient comfort, while ensuring that patients remain responsive to verbal cues. The ultrasound will be placed to visualize the short axis (cross-section) of the adductor canal. If both sites (above femoral artery versus between femoral artery and vein) are acceptable for catheter insertion, the subject will be randomized using a computer-generated list (blocks of 8) to one of two treatment groups in a 1:1 ratio using sealed, opaque, consecutively numbered envelopes: (1) above femoral artery vs (2) between femoral artery and vein. Catheter insertion will adhere to current UCSD standard-of-care. The only difference for subjects participating in the study will be that the specific catheter insertion location will be determined randomly, instead of the physician simply choosing him/herself. All catheters will be placed by a regional anesthesia fellow under the direct supervision and guidance of a regional anesthesia attending. All catheters will be placed using standard UCSD perineural catheter techniques. The area of insertion will be cleaned with chlorhexidine gluconate and isopropyl alcohol, and a clear, sterile, fenestrated drape applied. The ultrasound probe will be placed to visualize the short-axis (cross-section) of the target nerve(s). A 17-gauge needle (FlexTip, Teleflex Medical, Triangle Research Park, NC, USA) will be used to place all perineural catheters. The catheter-placement needle will be inserted through the skin wheal, advanced in-plane beneath the US transducer and directed to the target nerve as described below: "Above-the-artery": The needle will be directed below the nerve to about five o'clock of the artery. The needle will then be advanced to twelve o'clock of the artery while opening the adductor canal space with saline until adequate opening of the canal is realized. At that point, the catheter is placed above the artery. "Between-the-artery-and-vein": The needle will be directed above the nerve and placed at one o'clock of the artery. Then the needle will be positioned at about six o'clock of the artery and advanced between the femoral artery and vein with simultaneous pressure until the adductor canal opens appropriately. The perineural catheter will be placed between the artery and vein. Saline (10 mL) will be administered via the needle to dilate the space where the catheter is to be inserted. A flexible non-stimulating perineural catheter will be inserted 3-5 cm past the needle tip; and the needle withdrawn over the catheter. A 30 mL bolus of lidocaine 2% with 1:400,000 of epinephrine will then be administered through the catheter. Intraoperatively, patients may receive a general and/or neuraxial anesthetic that would be determined by the intraoperative anesthesia provider. Additional boluses of 10 mL 2% lidocaine with epinephrine may be given, if needed, via the perineural catheter. Perineural infusion: An infusion pump will be attached to each subject's perineural catheter. The pump will provide ropivacaine 0.2% at 6 mL/h and a 4 mL patient-controlled bolus with a 30-minute lockout. Data collection: All data collection will be through standard UCSD nursing/therapy electronic medical record notes for the day following surgery. Primary endpoint: The primary endpoint will be the average pain on post operative day 1 following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain) during the time periods of 08:00-24:00. Secondary endpoints: Other data collected will include: (1) total procedure duration (from needle-in to needle-out), (2) total opioid consumption on postoperative day 1, (3) worst pain score measured on a numeric rating scale, (4) number of intra-procedural vascular punctures, (5) total local anesthetic infused in 24 hours following surgery, and (6) distance ambulated on postoperative day 1 with first session of physical therapy. Sample size estimates: The primary analysis will utilize the Wilcoxon Rank Sum test. The mean postoperative day 1 pain scores following adductor canal catheter placement for total knee arthroplasty is 4.12 with standard deviation = 1.74.2 The null hypothesis is that the "above-the-artery" group is inferior to the "between-the-artery-and-vein" group. The alternative hypothesis is that the "above-the-artery" group in non-inferior to the "between-the-artery-and-vein" group. Assuming a non-inferiority limit of 1.5, power = 0.80, two-side alpha = 0.05, we will require 17 patients in each group (total = 34). To account for dropouts, we plan to recruit 20 patients in each group, totaling 40 patients all together.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Knee

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Above Artery Group
    Arm Type
    Experimental
    Arm Title
    Between Artery and Vein Group
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Above Artery Catheter Placement
    Intervention Description
    Nerve catheter placed between superficial femoral artery and sartorial muscle
    Intervention Type
    Procedure
    Intervention Name(s)
    Between Artery and Vein Placement
    Intervention Description
    Nerve catheter placed between superficial femoral artery and femoral vein
    Primary Outcome Measure Information:
    Title
    AVERAGE PAIN
    Description
    Average pain on post operative day 1 following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain).
    Time Frame
    08:00AM to 24:00 on the first day following surgery
    Secondary Outcome Measure Information:
    Title
    Procedure duration
    Time Frame
    Prior to surgery
    Title
    Opioid consumption
    Time Frame
    Postoperative days zero and one
    Title
    Distance Ambulated
    Time Frame
    Physical Therapy sessions on postoperative day one
    Title
    Worst pain score (NRS 0-10 reported by patient)
    Time Frame
    Postoperative day , entire day
    Title
    Number of vascular pictures during placement
    Time Frame
    During the catheter placement procedure
    Title
    Intravascular injection assessed by heart rate response to epinephrine in injection
    Time Frame
    During the catheter placement procedure
    Title
    Total local anesthetic infused on first postoperative day
    Time Frame
    Postoperative days zero and one

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing unilateral total knee arthroplasty at UC San Diego with planned placement of an adductor canal catheter at request of surgeon Exclusion Criteria: history of allergic reaction to lidocaine or ropivacaine history of peripheral neuropathy, neuropathic pain, or chronic pain requiring opioid medications. Pregnant females and prisoners
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    John J Finneran, MD
    Phone
    4083073004
    Email
    jfinneran@ucsd.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effects of Catheter Location Relative to Femoral Artery on Postoperative Analgesia for Continuous Adductor Canal Blocks

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