Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT03807505
Collaborator
(none)
30
1
2
6.6
4.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Interscalene brachial plexus nerve block
  • Procedure: Erector spinae plane block
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery
Actual Study Start Date :
Jun 13, 2019
Actual Primary Completion Date :
Nov 22, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Interscalene nerve block

Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot interscalene brachial plexus nerve block or an interscalene brachial plexus nerve catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively.

Procedure: Interscalene brachial plexus nerve block
An interscalene brachial plexus nerve block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.

Active Comparator: Erector Spinae Plane block

Patients undergoing rotator cuff repair surgery or total shoulder arthroplasty will undergo a single shot erector spinae plane block or receive erector spinae plane catheter. In the preoperative area, all participants will be asked baseline indicators of pain level via a Numeric Rating Scale (NRS, 0-10, where 0 is no pain and 10 is the worst imaginable pain) and diaphragmatic excursion will be measured bilaterally using ultrasonography before nerve block placement. Motor and sensory exams will also be performed. The same parameters will be measured 30 minutes after the block is performed. In the recovery room, those with nerve catheters will receive a dose of local anesthetic. All patients will have the same parameters measured 30 minutes postoperatively.

Procedure: Erector spinae plane block
An erector spinae plane block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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).

Secondary Outcome Measures

  1. 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

  2. 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

  3. Opioid Consumption [48 hours]

    Opioid consumption in the recovery room and in the first 48 hours postoperatively will be recorded

  4. Adverse effects [72 hours]

    Patient-reported adverse effects (dichotomous measure, yes/no): dyspnea, Horner syndrome, hoarseness, difficulty participating in physical therapy due to block

  5. Patient satisfaction [72 hours]

    Patient satisfaction with the nerve block (dichotomous measure: yes/no)

  6. Incentive spirometry volume change [24 hours]

    Change in incentive spirometry volume from baseline (prior to block) to recovery room, and to postoperative day 1.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stanford Health Care (SHC) Palo Alto California United States 94304

Sponsors and Collaborators

  • Stanford University

Investigators

  • Principal Investigator: Ban Tsui, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chi-Ho Ban Tsui, Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University
ClinicalTrials.gov Identifier:
NCT03807505
Other Study ID Numbers:
  • 48351
First Posted:
Jan 17, 2019
Last Update Posted:
Mar 5, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 5, 2020