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

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ClinicalTrials.gov Identifier: NCT03691922
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
McMaster University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthroscopic Shoulder Surgery Procedure: Erector Spinae Plane (ESP) Block Procedure: Periarticular Infiltration (PAI) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Control Trial of Ultrasound-Guided Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Pain Control After Arthroscopic Shoulder Surgery
Actual Study Start Date : July 6, 2019
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : February 1, 2021
Arms and Interventions
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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 Name: 0.25% bupivacaine with 5 mcg/mL of epinephrine & PAI with 30 mL of saline
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 Name: ESP block with 30 mL of saline & PAI with 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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)

  5. 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)

  6. 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".

  7. 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.

  8. 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.

  9. 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.

  10. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691922


Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Harsha Shanthanna, MD St. Joseph's Healthcare Hamilton/McMaster University
Principal Investigator: Bashar Alolabi, MD St. Joseph's Healthcare Hamilton
Principal Investigator: Mark Czuczman, MD McMaster University
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03691922    
Other Study ID Numbers: 4668
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
Shoulder
Pain
Erector Spinae Plane block
Surgery
Arthroscopy
 Periarticular infiltration
Post-Anesthesia Care Unit
Day Surgery Unit
Regional anesthesia
Analgesia
Additional relevant MeSH terms:
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Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents