Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery

Not Applicable

Completed

• Conditions: Anesthesia, Local; Phrenic Nerve Paralysis; Upper Extremity Injury; Shoulder Injury

• Registration Number: NCT03807505
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-17
• Study Start: 2019-06-13
• Primary Completion: 2019-11-22
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain score	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	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 Outcome Measures

Name	Time	Method
Brachial plexus motor exam change	Before block placement, and 30 minutes after catheter is bolused in recovery	Brachial plexus motor exam change: dichotomous measurement (yes or no) for change in finger extension, finger abduction and thumb opposition to resistance
Adverse effects	72 hours	Patient-reported adverse effects (dichotomous measure, yes/no): dyspnea, Horner syndrome, hoarseness, difficulty participating in physical therapy due to block
Opioid Consumption	48 hours	Opioid consumption in the recovery room and in the first 48 hours postoperatively will be recorded
Patient satisfaction	72 hours	Patient satisfaction with the nerve block (dichotomous measure: yes/no)
Brachial plexus sensory exam change	Before block placement, and 30 minutes after catheter is bolused in recovery	Brachial plexus sensory exam change: dichotomous measurement (yes or no) for change in sensation over C5-C8 dermatomes
Incentive spirometry volume change	24 hours	Change in incentive spirometry volume from baseline (prior to block) to recovery room, and to postoperative day 1.

Trial Locations

Locations (1)

Stanford Health Care (SHC); 🇺🇸 Palo Alto, California, United States