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