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NCT Number: NCT03807505

Erector Spinae Plane Versus Interscalene Blocks for Shoulder Surgery

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Health Care (SHC)

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interscalene brachial plexus nerve block

Procedure

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

Procedure

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 outcomes

  1. Incidence of diaphragmatic paresis or paralysis

    Time frame: 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

    Time frame: 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 outcomes

  1. Brachial plexus sensory exam change

    Time frame: 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

    Time frame: 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

    Time frame: 48 hours

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

  4. Adverse effects

    Time frame: 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

    Time frame: 72 hours

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

  6. Incentive spirometry volume change

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2019
Registry last updated
Mar 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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