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Not yet recruiting NCT05653570

Electrical Stimulation for Erector Spinae Plane Catheter Insertion

No phase Interventional Postoperative Pain, Acute Shoulder Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electrical stimulation, Ultrasound.
Who it may be relevant to
Registry conditions: Postoperative Pain, Acute, Shoulder Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Number of patients with erector spinae muscle stimulation via stimulating catheter [Time frame: Immediately after catheter placement (up to 5 minutes to assess)]
Secondary outcome measures (12)
  • Time to perform erector spinae plane catheter [Time frame: 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)]
  • Highest and lowest vertebral level of sensory change after local anesthetic bolus [Time frame: 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)]
  • Incidence of brachial plexus or intercostal stimulation via stimulating catheter after local anesthetic bolus [Time frame: 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)]
  • Opioid consumption on postoperative day (POD) 1 [Time frame: POD1 (24 hours)]
  • Opioid consumption on postoperative day (POD) 2 [Time frame: POD2 (24 hours)]
  • Opioid consumption on postoperative day (POD) 3 [Time frame: POD3 (24 hours)]
  • Average postoperative pain on postoperative day (POD) 1 [Time frame: POD1 (24 hours)]
  • Average postoperative pain on postoperative day (POD) 2 [Time frame: POD2 (24 hours)]
  • Average postoperative pain on postoperative day (POD) 3 [Time frame: POD3 (24 hours)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05653570 · 68478

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗