Electrical Stimulation for Erector Spinae Plane Catheter Insertion

April 17, 2025 updated by: Jan Boublik, Stanford University

Electrical Stimulation for Erector Spinae Plane Catheter Insertion: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ultrasound Guidance Only
Diagnostic test: Ultrasound
Ultrasound guidance will be used to visualize needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process.
Experimental: Electrical stimulation and Ultrasound Guidance
Diagnostic test: Ultrasound
Ultrasound guidance will be used to visualize needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process.
Diagnostic test: Electrical stimulation
Electrical stimulation will be used to confirm needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients with erector spinae muscle stimulation via stimulating catheter
Time Frame: Immediately after catheter placement (up to 5 minutes to assess)
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.
Immediately after catheter placement (up to 5 minutes to assess)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to perform erector spinae plane catheter
Time Frame: During catheter placement (up to 20 minutes)
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.
During catheter placement (up to 20 minutes)
Worst pain score ratings in the postanesthesia care unit (PACU)
Time Frame: as soon as patient can respond in PACU (up to 1 hour)
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)
as soon as patient can respond in PACU (up to 1 hour)
Highest and lowest vertebral level of sensory change after local anesthetic bolus
Time Frame: preoperatively, 30 minutes 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.
preoperatively, 30 minutes after local anesthetic bolus
Incidence of brachial plexus or intercostal stimulation via stimulating catheter before local anesthetic bolus
Time Frame: preoperatively, prior to local anesthetic bolus (up to 5 minutes)
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.
preoperatively, prior to local anesthetic bolus (up to 5 minutes)
Incidence of brachial plexus or intercostal stimulation via stimulating catheter after local anesthetic bolus
Time Frame: preoperatively, 30 minutes 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.
preoperatively, 30 minutes after local anesthetic bolus
Opioid consumption in the PACU
Time Frame: from admission to discharge from the PACU (average approximately 2 hours)
The subject's total opioid administration in the PACU will be documented and converted to oral morphine milliequivalents (MME).
from admission to discharge from the PACU (average approximately 2 hours)
Opioid consumption on postoperative day (POD) 1
Time Frame: POD1 (24 hours)
The subject's total opioid administration on POD1 will be documented and converted to oral morphine milliequivalents (MME).
POD1 (24 hours)
Opioid consumption on postoperative day (POD) 2
Time Frame: POD2 (24 hours)
The subject's total opioid administration on POD2 will be documented and converted to oral morphine milliequivalents (MME).
POD2 (24 hours)
Opioid consumption on postoperative day (POD) 3
Time Frame: POD3 (24 hours)
The subject's total opioid administration on POD3 will be documented and converted to oral morphine milliequivalents (MME).
POD3 (24 hours)
Average postoperative pain on postoperative day (POD) 1
Time Frame: POD1 (24 hours)
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)
POD1 (24 hours)
Average postoperative pain on postoperative day (POD) 2
Time Frame: POD2 (24 hours)
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)
POD2 (24 hours)
Average postoperative pain on postoperative day (POD) 3
Time Frame: POD3 (24 hours)
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)
POD3 (24 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan Boublik, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 68478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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