Clinical trial NCT05653570: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Pain, Acute
Shoulder Pain
Keywords: erector spinae plane
electrical stimulation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Number of patients with erector spinae muscle stimulation via stimulating catheter
timeFrame: Immediately after catheter placement (up to 5 minutes to assess)
Secondary outcomes:
measure: Time to perform erector spinae plane catheter
timeFrame: During catheter placement (up to 20 minutes)
measure: Worst pain score ratings in the postanesthesia care unit (PACU)
timeFrame: as soon as patient can respond in PACU (up to 1 hour)
measure: Highest and lowest vertebral level of sensory change after local anesthetic bolus
timeFrame: preoperatively, 30 minutes after local anesthetic bolus
measure: Incidence of brachial plexus or intercostal stimulation via stimulating catheter before local anesthetic bolus
timeFrame: preoperatively, prior to local anesthetic bolus (up to 5 minutes)
measure: Incidence of brachial plexus or intercostal stimulation via stimulating catheter after local anesthetic bolus
timeFrame: preoperatively, 30 minutes after local anesthetic bolus
measure: Opioid consumption in the PACU
timeFrame: from admission to discharge from the PACU (average approximately 2 hours)
measure: Opioid consumption on postoperative day (POD) 1
timeFrame: POD1 (24 hours)
measure: Opioid consumption on postoperative day (POD) 2
timeFrame: POD2 (24 hours)
measure: Opioid consumption on postoperative day (POD) 3
timeFrame: POD3 (24 hours)
measure: Average postoperative pain on postoperative day (POD) 1
timeFrame: POD1 (24 hours)
measure: Average postoperative pain on postoperative day (POD) 2
timeFrame: POD2 (24 hours)
measure: Average postoperative pain on postoperative day (POD) 3
timeFrame: POD3 (24 hours)
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Jan Boublik, MD
role: PRINCIPAL_INVESTIGATOR
References: