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Electrical Stimulation for Erector Spinae Plane Catheter Insertion

Primary Purpose

Postoperative Pain, Acute, Shoulder Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electrical stimulation
Ultrasound
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Pain, Acute focused on measuring erector spinae plane, electrical stimulation

Eligibility Criteria

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

Inclusion Criteria: elective total or total reverse shoulder arthroplasty Exclusion Criteria: inability to provide consent history of active opioid use emergency procedures shoulder arthroscopy partial shoulder replacement shoulder resurfacing any revision shoulder surgery any indwelling deep brain stimulator, pacemaker, and/or other neurostimulators

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Ultrasound Guidance Only

    Electrical stimulation and Ultrasound Guidance

    Arm Description

    Outcomes

    Primary Outcome Measures

    Number of patients with erector spinae muscle stimulation via stimulating catheter
    Successful erector spinae plane needle and catheter insertion means that the needle/catheter is deep to the myofascia of the erector spinae muscle complex and superficial to the intertransverse ligaments / transverse process. Thus, any stimulation of the catheter after its placement in the erector spinae muscle complex seen under ultrasound or perceived by the patient will be documented as catheter placement failure. No visualized or perceived stimulation of the erector spinae muscle complex will be documented as catheter placement success.

    Secondary Outcome Measures

    Time to perform erector spinae plane catheter
    Time for catheter placement will begin when the US probe first touches the patient and end when the inner stimulating catheter hub meets the skin. If no visual identification of the target erector spinae plane (US) and no evoked motor respoinse (US+ES) is achieved within 10 minutes, the placement will be considered a failure, and the primary end point will be recorded as 10 minutes. If a catheter cannot be placed per protocol within 20 minutes, the placement will be considered a failure, and the primary endpoint will be recorded as 20 minutes. In such cases, the subject will have a catheter placement attempt using the alternative method. Subjects who do not have a catheter placed as per their randomized group protocol will be removed from further study.
    Worst pain score ratings in the postanesthesia care unit (PACU)
    As soon as the patient is able to respond verbally in the PACU, the subject will be asked to rate their pain on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
    Highest and lowest vertebral level of sensory change after local anesthetic bolus
    We will administer cold spray (name, manufacturer location) 3 cm lateral to the spinous process from C1 to T12, and document the highest and lowest dermatomal levels of when the patient detects a difference in temperature sensation compared to the contralateral side.
    Incidence of brachial plexus or intercostal stimulation via stimulating catheter before local anesthetic bolus
    Prior to local anesthetic bolus, any perceived stimulation of an intercostal muscle or in the distribution of the brachial plexus on the operative side, including but not limited to twitching of or warmth of skin overlying the deltoid, biceps, triceps, supraspinatus, infraspinatus, pectoralis major/minor, and teres major/minor, will be documented.
    Incidence of brachial plexus or intercostal stimulation via stimulating catheter after local anesthetic bolus
    30 minutes after local anesthetic bolus, any perceived stimulation of an intercostal muscle or in the distribution of the brachial plexus on the operative side, including but not limited to twitching of or warmth of skin overlying the deltoid, biceps, triceps, supraspinatus, infraspinatus, pectoralis major/minor, and teres major/minor, will be documented.
    Opioid consumption in the PACU
    The subject's total opioid administration in the PACU will be documented and converted to oral morphine milliequivalents (MME).
    Opioid consumption on postoperative day (POD) 1
    The subject's total opioid administration on POD1 will be documented and converted to oral morphine milliequivalents (MME).
    Opioid consumption on postoperative day (POD) 2
    The subject's total opioid administration on POD2 will be documented and converted to oral morphine milliequivalents (MME).
    Opioid consumption on postoperative day (POD) 3
    The subject's total opioid administration on POD3 will be documented and converted to oral morphine milliequivalents (MME).
    Average postoperative pain on postoperative day (POD) 1
    The subject's average postoperative pain score ratings will be calculated on POD 1. Pain scored on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
    Average postoperative pain on postoperative day (POD) 2
    The subject's average postoperative pain score ratings will be calculated on POD 2 Pain scored on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
    Average postoperative pain on postoperative day (POD) 3
    The subject's average postoperative pain score ratings will be calculated on POD 3 Pain scored on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)

    Full Information

    First Posted
    December 8, 2022
    Last Updated
    April 13, 2023
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05653570
    Brief Title
    Electrical Stimulation for Erector Spinae Plane Catheter Insertion
    Official Title
    Electrical Stimulation for Erector Spinae Plane Catheter Insertion: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    October 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    The erector spinae plane (ESP) block has been studied for analgesia in shoulder surgery as a phrenic nerve-sparing alternative. However, successful ESP catheter placement appears multifactorial, with failure mechanisms including lamination, plane collapse, or catheter overcoiling. Electrical stimulation (ES) is a common technique used in regional anesthesia to detect possible intraneural placement. ES of the erector spinae muscle complex may objectively guide proper interfascial catheter placement and improve local anesthetic spread. The primary goal of this study is to establish if ESP catheter placement with the addition of ES to ultrasound (US) guidance facilitates accurate catheter placement. This study will further characterize postoperative analgesia and the incidence of brachial plexus stimulation for patients who receive ES-assisted ESP catheter placement.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Acute, Shoulder Pain
    Keywords
    erector spinae plane, electrical stimulation

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound Guidance Only
    Arm Type
    Active Comparator
    Arm Title
    Electrical stimulation and Ultrasound Guidance
    Arm Type
    Experimental
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Electrical stimulation
    Intervention Description
    Electrical stimulation will be used to confirm needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Ultrasound
    Intervention Description
    Ultrasound guidance will be used to visualize needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process.
    Primary Outcome Measure Information:
    Title
    Number of patients with erector spinae muscle stimulation via stimulating catheter
    Description
    Successful erector spinae plane needle and catheter insertion means that the needle/catheter is deep to the myofascia of the erector spinae muscle complex and superficial to the intertransverse ligaments / transverse process. Thus, any stimulation of the catheter after its placement in the erector spinae muscle complex seen under ultrasound or perceived by the patient will be documented as catheter placement failure. No visualized or perceived stimulation of the erector spinae muscle complex will be documented as catheter placement success.
    Time Frame
    Immediately after catheter placement (up to 5 minutes to assess)
    Secondary Outcome Measure Information:
    Title
    Time to perform erector spinae plane catheter
    Description
    Time for catheter placement will begin when the US probe first touches the patient and end when the inner stimulating catheter hub meets the skin. If no visual identification of the target erector spinae plane (US) and no evoked motor respoinse (US+ES) is achieved within 10 minutes, the placement will be considered a failure, and the primary end point will be recorded as 10 minutes. If a catheter cannot be placed per protocol within 20 minutes, the placement will be considered a failure, and the primary endpoint will be recorded as 20 minutes. In such cases, the subject will have a catheter placement attempt using the alternative method. Subjects who do not have a catheter placed as per their randomized group protocol will be removed from further study.
    Time Frame
    During catheter placement (up to 20 minutes)
    Title
    Worst pain score ratings in the postanesthesia care unit (PACU)
    Description
    As soon as the patient is able to respond verbally in the PACU, the subject will be asked to rate their pain on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
    Time Frame
    as soon as patient can respond in PACU (up to 1 hour)
    Title
    Highest and lowest vertebral level of sensory change after local anesthetic bolus
    Description
    We will administer cold spray (name, manufacturer location) 3 cm lateral to the spinous process from C1 to T12, and document the highest and lowest dermatomal levels of when the patient detects a difference in temperature sensation compared to the contralateral side.
    Time Frame
    preoperatively, 30 minutes after local anesthetic bolus
    Title
    Incidence of brachial plexus or intercostal stimulation via stimulating catheter before local anesthetic bolus
    Description
    Prior to local anesthetic bolus, any perceived stimulation of an intercostal muscle or in the distribution of the brachial plexus on the operative side, including but not limited to twitching of or warmth of skin overlying the deltoid, biceps, triceps, supraspinatus, infraspinatus, pectoralis major/minor, and teres major/minor, will be documented.
    Time Frame
    preoperatively, prior to local anesthetic bolus (up to 5 minutes)
    Title
    Incidence of brachial plexus or intercostal stimulation via stimulating catheter after local anesthetic bolus
    Description
    30 minutes after local anesthetic bolus, any perceived stimulation of an intercostal muscle or in the distribution of the brachial plexus on the operative side, including but not limited to twitching of or warmth of skin overlying the deltoid, biceps, triceps, supraspinatus, infraspinatus, pectoralis major/minor, and teres major/minor, will be documented.
    Time Frame
    preoperatively, 30 minutes after local anesthetic bolus
    Title
    Opioid consumption in the PACU
    Description
    The subject's total opioid administration in the PACU will be documented and converted to oral morphine milliequivalents (MME).
    Time Frame
    from admission to discharge from the PACU (average approximately 2 hours)
    Title
    Opioid consumption on postoperative day (POD) 1
    Description
    The subject's total opioid administration on POD1 will be documented and converted to oral morphine milliequivalents (MME).
    Time Frame
    POD1 (24 hours)
    Title
    Opioid consumption on postoperative day (POD) 2
    Description
    The subject's total opioid administration on POD2 will be documented and converted to oral morphine milliequivalents (MME).
    Time Frame
    POD2 (24 hours)
    Title
    Opioid consumption on postoperative day (POD) 3
    Description
    The subject's total opioid administration on POD3 will be documented and converted to oral morphine milliequivalents (MME).
    Time Frame
    POD3 (24 hours)
    Title
    Average postoperative pain on postoperative day (POD) 1
    Description
    The subject's average postoperative pain score ratings will be calculated on POD 1. Pain scored on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
    Time Frame
    POD1 (24 hours)
    Title
    Average postoperative pain on postoperative day (POD) 2
    Description
    The subject's average postoperative pain score ratings will be calculated on POD 2 Pain scored on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
    Time Frame
    POD2 (24 hours)
    Title
    Average postoperative pain on postoperative day (POD) 3
    Description
    The subject's average postoperative pain score ratings will be calculated on POD 3 Pain scored on an 11-point numeric rating scale (NRS, 0 being no pain and 10 being worst possible pain)
    Time Frame
    POD3 (24 hours)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: elective total or total reverse shoulder arthroplasty Exclusion Criteria: inability to provide consent history of active opioid use emergency procedures shoulder arthroscopy partial shoulder replacement shoulder resurfacing any revision shoulder surgery any indwelling deep brain stimulator, pacemaker, and/or other neurostimulators
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Richard K Kim, MD
    Phone
    6505041847
    Email
    rkwkim@stanford.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard K Kim, MD
    Organizational Affiliation
    Stanford University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Electrical Stimulation for Erector Spinae Plane Catheter Insertion

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