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Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery

Primary Purpose

Anesthesia, Local, Phrenic Nerve Paralysis, Upper Extremity Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interscalene brachial plexus nerve block
Erector spinae plane block
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Local

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Health Care (SHC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interscalene nerve block

Erector Spinae Plane block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of diaphragmatic paresis or paralysis
Change in diaphragmatic excursion (measured bilaterally using ultrasonography) from before block placement to 30 minutes after catheter is bolused in recovery
Pain score
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

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

Full Information

First Posted
December 14, 2018
Last Updated
March 4, 2020
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03807505
Brief Title
Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery
Official Title
Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 13, 2019 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local, Phrenic Nerve Paralysis, Upper Extremity Injury, Shoulder Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interscalene nerve block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Erector Spinae Plane block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Interscalene brachial plexus nerve block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae plane block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of diaphragmatic paresis or paralysis
Description
Change in diaphragmatic excursion (measured bilaterally using ultrasonography) from before block placement to 30 minutes after catheter is bolused in recovery
Time Frame
Before block placement, and 30 minutes after catheter is bolused in recovery
Title
Pain score
Description
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).
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Brachial plexus sensory exam change
Description
Brachial plexus sensory exam change: dichotomous measurement (yes or no) for change in sensation over C5-C8 dermatomes
Time Frame
Before block placement, and 30 minutes after catheter is bolused in recovery
Title
Brachial plexus motor exam change
Description
Brachial plexus motor exam change: dichotomous measurement (yes or no) for change in finger extension, finger abduction and thumb opposition to resistance
Time Frame
Before block placement, and 30 minutes after catheter is bolused in recovery
Title
Opioid Consumption
Description
Opioid consumption in the recovery room and in the first 48 hours postoperatively will be recorded
Time Frame
48 hours
Title
Adverse effects
Description
Patient-reported adverse effects (dichotomous measure, yes/no): dyspnea, Horner syndrome, hoarseness, difficulty participating in physical therapy due to block
Time Frame
72 hours
Title
Patient satisfaction
Description
Patient satisfaction with the nerve block (dichotomous measure: yes/no)
Time Frame
72 hours
Title
Incentive spirometry volume change
Description
Change in incentive spirometry volume from baseline (prior to block) to recovery room, and to postoperative day 1.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ban Tsui, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Health Care (SHC)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2006740
Citation
Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.
Results Reference
background
PubMed Identifier
18682410
Citation
Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.
Results Reference
background
PubMed Identifier
30292068
Citation
Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
Results Reference
background
PubMed Identifier
29868941
Citation
Tsui BCH, Mohler D, Caruso TJ, Horn JL. Cervical erector spinae plane block catheter using a thoracic approach: an alternative to brachial plexus blockade for forequarter amputation. Can J Anaesth. 2019 Jan;66(1):119-120. doi: 10.1007/s12630-018-1170-7. Epub 2018 Jun 4. No abstract available.
Results Reference
background
PubMed Identifier
29134518
Citation
Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13.
Results Reference
background
PubMed Identifier
35237953
Citation
Sun LY, Basireddy S, Gerber LN, Lamano J, Costouros J, Cheung E, Boublik J, Horn JL, Tsui BCH. Continuous interscalene versus phrenic nerve-sparing high-thoracic erector spinae plane block for total shoulder arthroplasty: a randomized controlled trial. Can J Anaesth. 2022 May;69(5):614-623. doi: 10.1007/s12630-022-02216-1. Epub 2022 Mar 2.
Results Reference
derived

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Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery

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