Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Arthroscopic Shoulder Surgery

February 23, 2021 updated by: McMaster University

Randomized Control Trial of Ultrasound-Guided Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Pain Control After Arthroscopic Shoulder Surgery

Arthroscopic shoulder surgery is a common and minimally invasive procedure utilized for different shoulder pathologies, but it is often associated with moderate to severe postoperative pain that may interfere with patients' well-being and course of recovery. By using an effective analgesic technique with few side effects, a patient may experience less pain after surgery, have a shortened hospital stay, and endure less nausea, vomiting, or excessive drowsiness that are associated with the use of opioids to manage postoperative pain. Periarticular infiltration (PAI) with local anesthetic (LA) has been used for shoulder surgery pain management, but the more effective interscalene nerve block (ISNB) is the current gold standard analgesic modality despite risk of significant side effects including diaphragm paralysis and rebound pain. In this study, the investigators want to look at the effectiveness and safety profile of a novel technique for pain management after shoulder surgery that has the potential to provide successful pain relief with minimal risk of side effects. Half of the patients will be randomly selected to receive the novel nerve block called the Erector Spinae Plane (ESP) block while the other half will receive a more standard PAI of local anesthetic to numb the shoulder. Patients' pain intensity and opioid consumption in the post-anesthesia care unit (PACU) as well as during the first 24 hours after surgery will be evaluated. Any complications from the interventions will also be noted. The investigators predict that the ESP block will provide superior analgesia compared to PAI for these shoulder arthroscopy patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of opioids to manage immediate postoperative pain is frequently associated with nausea, vomiting, respiratory depression, hormonal effects and dysphoria. As such, achieving pain control while minimizing opioid use is critical, since more than 60% of unplanned prolonged hospitalizations and hospital readmissions are thought to be related to inadequate pain control or to side effects of opioids. A number of techniques have been used to achieve good pain control after arthroscopic shoulder surgery, including periarticular infiltration (PAI) with local anesthetic (LA) and regional anesthetic nerve blocks. Although PAI in the shoulder has been shown to decrease shoulder pain and opioid consumption, it is not as effective as regional blocks such as the interscalene nerve block (ISNB), which is the current gold standard. Nevertheless, the ISNB is potentially associated with significant side effects including persistent neurologic complications, rebound pain, phrenic nerve palsy, respiratory distress, cardiac arrest pneumothorax and central nerve toxicity. In view of this, investigating alternate regional blocks having the potential for good pain relief with minimal side effects is important. The Erector Spinae Plane (ESP) block can be considered as a modification of thoracic paravertebral block (PVB) that blocks thoracic spinal nerves using injections outside of the conventional paravertebral space. It is performed under ultrasound (US) by injecting local anesthetic deep to the erector spinae muscle at the interfascial space between either the erector spinae muscle and the rhomboid major muscle (higher up), or between the erector spinae muscle and the external intercostal muscles, at lower sites. Cadaveric studies of ultrasound-guided ESP blocks with methylene blue dye and subsequent dissection, as well an ESP block with a dye mixture and CT scanning demonstrated that when injecting deep into the erector spinae, the block likely affects the ventral and dorsal rami leading to the sensory blockade. The advantages include its simplicity and safety by limiting the risk of nerve damage and pneumothorax. Various case reports have demonstrated the ESP block to be successful for abdominal, breast and axillary, and other surgery types, and a recent case report described the successful management of chronic shoulder pain without motor blockade, with ESP performed at T3 level. The investigators conducted a systematic review via Pubmed to identify studies that have utilized ESP for post-surgical shoulder pain. Out of 77 reports, the investigators did not identify any comparative studies looking at the potential of ESP for shoulder surgery pain. The investigators also looked into ongoing and proposed trials of ESP by looking into clinicaltrials.gov. The investigators identified 21 studies including some randomized controlled trials (RCT) for thoracic surgery and general surgery population, but none for shoulder surgeries. Given the importance of providing adequate analgesia for arthroscopic shoulder surgery and lack of consensus amongst surgeons and anesthesiologists for the optimal analgesic technique, this trial will help establish the effectiveness of the ESP block in pain control after shoulder arthroscopy and define its safety profile. The results of this trial will allow the clinician to inform patients accurately regarding the benefits and risks of the block and thus guide the clinical practice of this block for shoulder arthroscopy. If proven to be effective, it may be used as an alternative to ISNB, especially in cases where ISNB is contraindicated.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective arthroscopic shoulder joint surgeries admitted for day surgical procedure
  • an ability to provide informed consent

Exclusion Criteria:

  • not willing
  • contraindications to spinal injections as per the American Society of Regional Anesthesia and Pain (ASRA) guidelines
  • known allergy to LA
  • allergy to all opioid medications
  • diagnostic shoulder arthroscopic procedures
  • inability to understand or comprehend in English language
  • history of daily opioid medication use for the last one month
  • patients with planned overnight hospital stay

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ESP Block
Preoperative US guided active Erector Spinae Plane (ESP) block and a saline PAI
Procedure: Erector Spinae Plane (ESP) Block
  1. Preoperative US guided ESP blockade using 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine, injected in 5-mL aliquots through the needle (maximum of 3 mg/kg)
  2. PAI of 30 mL of saline at the end of the surgical procedure on the operated side rotator cuff, injected in 5-mL aliquots through the needle
Other Names:
  • 0.25% bupivacaine with 5 mcg/mL of epinephrine & PAI with 30 mL of saline
Other: PAI with LA
Preoperative US guided ESP blockade with saline and an active Periarticular Infiltration (PAI)
Procedure: Periarticular Infiltration (PAI)
  1. Preoperative US guided ESP blockade using 30 mL of saline, injected in 5-mL aliquots through the needle
  2. PAI of 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine at the end of the surgical procedure on the operated side rotator cuff, injected in 5-mL aliquots through the needle
Other Names:
  • ESP block with 30 mL of saline & PAI with 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery room resting pain score
Time Frame: At 30 minutes post-admission to recovery room
Using the patient-reported numeric rating scale (0-10) (0 is no pain and 10 is worst pain imaginable).
At 30 minutes post-admission to recovery room

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Day Surgery Unit resting pain score
Time Frame: At 5 hours post-operatively
Using the patient-reported numeric rating scale (0-10) (0 is no pain and 10 is worst pain imaginable).
At 5 hours post-operatively
Pain scores with movement
Time Frame: At 30 minutes post-admission to recovery room and 5 hours post-operatively
Using the patient-reported numeric rating scale (0-10). (0 is no pain and 10 is worst pain imaginable). Participants will be asked to sit up from lying down position.
At 30 minutes post-admission to recovery room and 5 hours post-operatively
Opioid usage
Time Frame: At 2 hours post-operatively and 5 hours post-operatively
All opioids administered in recovery room and day surgery unit will be converted into Morphine Equivalent Units per patient according to accepted standards.
At 2 hours post-operatively and 5 hours post-operatively
Incidence of moderate to severe postoperative nausea-vomiting
Time Frame: At 2 hours post-operatively and 5 hours post-operatively
Using a 0-3 scale (0 is none and 3 severe nausea-vomiting)
At 2 hours post-operatively and 5 hours post-operatively
Incidence of moderate to severe itching
Time Frame: At 2 hours post-operatively and 5 hours post-operatively
Using a 0-3 scale (0 is none and 3 severe itching)
At 2 hours post-operatively and 5 hours post-operatively
Incidence of ipsilateral diaphragmatic paralysis
Time Frame: 30 minutes post-admission to recovery room
Diagnosed based on the findings in an anterior posterior chest using ultrasound , with the criteria of "a right hemidiaphragm sitting >2 cm higher than its left counterpart or a left hemidiaphragm sitting equal or higher than the right hemidiaphragm".
30 minutes post-admission to recovery room
Incidence of respiratory depression
Time Frame: At 2 hours post-operatively and 5 hours post-operatively
Opioids discontinued by the Acute Pain Service or recovery room nursing due to concerns of respiratory depression by nursing staff.
At 2 hours post-operatively and 5 hours post-operatively
Incidence of local anesthetic toxicity
Time Frame: At 2 hours post-operatively and 5 hours post-operatively
Based on clinical symptoms and signs of local anesthetic toxicity as diagnosed by the attending physician.
At 2 hours post-operatively and 5 hours post-operatively
Sensory blockade
Time Frame: At 30 minutes post-admission to recovery room
Seven sensory dermatomes corresponding to shoulder and upper arm and their blockade to cold sensation will be noted. The extent of blockade between the two groups will be compared by their median and range.
At 30 minutes post-admission to recovery room
Patient Satisfaction with Postoperative Analgesia
Time Frame: At 5 hours post-operatively and 24 hours post-operatively
Using a 7-item Likert scale (1 is extremely satisfied and 7 is extremely dissatisfied)
At 5 hours post-operatively and 24 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Investigators

  • Principal Investigator: Bashar Alolabi, MD, St. Joseph's Healthcare Hamilton
  • Principal Investigator: Mark Czuczman, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2019

Primary Completion (Actual)

February 1, 2020

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

September 18, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4668

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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