Skip to main content
Clinical Trials/NCT03807505
NCT03807505
Completed
Not Applicable

Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery

Stanford University1 site in 1 country30 target enrollmentJune 13, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Local
Sponsor
Stanford University
Enrollment
30
Locations
1
Primary Endpoint
Pain score
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The goal of this study is the evaluation of erector spinae plane (ESP) blocks as an alternative to interscalene brachial plexus nerve blocks for rotator cuff repair and total shoulder arthroplasty procedures. Currently, single shot interscalene nerve blocks are performed for rotator cuff repair surgeries, and interscalene nerve catheters are placed for total shoulder arthroplasty surgeries. Erector spinae plane blocks are commonly used as part of the anesthetic plan for other surgeries, but less so for shoulder surgeries. The investigators would like to study whether an ESP block can provide similar pain control compared to an interscalene nerve block, with less risk of upper extremity motor block and phrenic nerve block.

Registry
clinicaltrials.gov
Start Date
June 13, 2019
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chi-Ho Ban Tsui

Professor of Anesthesiology, Perioperative and Pain Medicine

Stanford University

Eligibility Criteria

Inclusion Criteria

  • All adult patients (18 years and over) scheduled for rotator cuff surgery or total shoulder arthroplasty surgery requiring a nerve block as part of their anesthetic care

Exclusion Criteria

  • concomitant life-threatening injuries and other concomitant injuries causing significant pain.
  • pregnancy,
  • any condition impairing patient's ability to consent to participation in study
  • an existing condition contraindicating a nerve block, i.e. nerve injury, existing bleeding disorder
  • infection in the vicinity of the block, and patient refusal.

Outcomes

Primary Outcomes

Pain score

Time Frame: 48 hours

Pain scores for all patients will be recorded through the first 48 hours postoperatively using the Numeric Rating scale (ranging from 0 to 10, 0 is no pain and 10 is the worst imaginable pain).

Incidence of diaphragmatic paresis or paralysis

Time Frame: Before block placement, and 30 minutes after catheter is bolused in recovery

Change in diaphragmatic excursion (measured bilaterally using ultrasonography) from before block placement to 30 minutes after catheter is bolused in recovery

Secondary Outcomes

  • Brachial plexus motor exam change(Before block placement, and 30 minutes after catheter is bolused in recovery)
  • Incentive spirometry volume change(24 hours)
  • Adverse effects(72 hours)
  • Opioid Consumption(48 hours)
  • Patient satisfaction(72 hours)
  • Brachial plexus sensory exam change(Before block placement, and 30 minutes after catheter is bolused in recovery)

Study Sites (1)

Loading locations...

Similar Trials