Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery

Anesthesia, Local Clinical Trial

Official title:

Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807505
• Other study ID #: 48351
• Status: Completed
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Arm Injuries
• Paralysis
• Phrenic Nerve Paralysis
• Shoulder Injuries
• Shoulder Injury
• Upper Extremity Injury
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Stanford Health Care (SHC)	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

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