Clinical trial NCT03807505: Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery
Official title: Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Phrenic Nerve Paralysis
Upper Extremity Injury
Shoulder Injury
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of diaphragmatic paresis or paralysis
timeFrame: Before block placement, and 30 minutes after catheter is bolused in recovery
measure: Pain score
timeFrame: 48 hours
Secondary outcomes:
measure: Brachial plexus sensory exam change
timeFrame: Before block placement, and 30 minutes after catheter is bolused in recovery
measure: Brachial plexus motor exam change
timeFrame: Before block placement, and 30 minutes after catheter is bolused in recovery
measure: Opioid Consumption
timeFrame: 48 hours
measure: Adverse effects
timeFrame: 72 hours
measure: Patient satisfaction
timeFrame: 72 hours
measure: Incentive spirometry volume change
timeFrame: 24 hours
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Health Care (SHC)
state: California
Study officials:
affiliation: Stanford University
name: Ban Tsui, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.