Electrical Stimulation for Erector Spinae Plane Catheter Insertion

NCT ID: NCT05653570

Last Updated: 2025-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain, Acute Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Ultrasound Guidance Only

Group Type ACTIVE_COMPARATOR

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound guidance will be used to visualize needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process.

Electrical stimulation and Ultrasound Guidance

Group Type EXPERIMENTAL

Electrical stimulation

Intervention Type DIAGNOSTIC_TEST

Electrical stimulation will be used to confirm needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process.

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Ultrasound guidance will be used to visualize needle and catheter placement within the interfascial plane between the erector spinae muscle and thoracic transverse process.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jan Boublik

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Boublik, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Central Contacts

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Jan Boublik, MD

Role: CONTACT

(917) 617-6261

Other Identifiers

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68478

Identifier Type: -

Identifier Source: org_study_id

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