Electrical Stimulation for Erector Spinae Plane Catheter Insertion

NCT05653570 | Not Yet Recruiting FDA Device

• 1 other identifier: 68478
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain, Acute; Shoulder Pain

Keywords

erector spinae plane; electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after catheter placement (up to 5 minutes to assess)

Secondary Outcomes (12)

• Time to perform erector spinae plane catheter

  During catheter placement (up to 20 minutes)

• Worst pain score ratings in the postanesthesia care unit (PACU)

  as soon as patient can respond in PACU (up to 1 hour)

• Highest and lowest vertebral level of sensory change after local anesthetic bolus

  preoperatively, 30 minutes after local anesthetic bolus

• Incidence of brachial plexus or intercostal stimulation via stimulating catheter before local anesthetic bolus

  preoperatively, prior to local anesthetic bolus (up to 5 minutes)

• Incidence of brachial plexus or intercostal stimulation via stimulating catheter after local anesthetic bolus

  preoperatively, 30 minutes after local anesthetic bolus

Study Arms (2)

Ultrasound Guidance Only

ACTIVE COMPARATOR

Diagnostic Test: Ultrasound

Electrical stimulation and Ultrasound Guidance

EXPERIMENTAL

Diagnostic Test: Electrical stimulation; Diagnostic Test: Ultrasound

Interventions

Electrical stimulation 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.

Electrical stimulation and Ultrasound Guidance

Ultrasound 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; Ultrasound Guidance Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective total or total reverse shoulder arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Jan Boublik, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Boublik, MD

CONTACT

(917) 617-6261; jboublik@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 21, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share