Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Arthroscopic Shoulder Surgery
Randomized Control Trial of Ultrasound-Guided Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Pain Control After Arthroscopic Shoulder Surgery
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: ESP Block
Preoperative US guided active Erector Spinae Plane (ESP) block and a saline PAI
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Other Names:
|
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Other: PAI with LA
Preoperative US guided ESP blockade with saline and an active Periarticular Infiltration (PAI)
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery room resting pain score
Time Frame: At 30 minutes post-admission to recovery room
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Using the patient-reported numeric rating scale (0-10) (0 is no pain and 10 is worst pain imaginable).
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At 30 minutes post-admission to recovery room
|
Secondary Outcome Measures
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.
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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.
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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)
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At 2 hours post-operatively and 5 hours post-operatively
|
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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
|
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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".
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30 minutes post-admission to recovery room
|
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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.
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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
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Using a 7-item Likert scale (1 is extremely satisfied and 7 is extremely dissatisfied)
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At 5 hours post-operatively and 24 hours post-operatively
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Bashar Alolabi, MD, St. Joseph's Healthcare Hamilton
- Principal Investigator: Mark Czuczman, MD, McMaster University
- Principal Investigator: Harsha Shanthanna, MD, St. Joseph's Healthcare Hamilton/McMaster University
Publications and helpful links
General Publications
- Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Fontana C, Di Donato A, Di Giacomo G, Costantini A, De Vita A, Lancia F, Caricati A. Postoperative analgesia for arthroscopic shoulder surgery: a prospective randomized controlled study of intraarticular, subacromial injection, interscalenic brachial plexus block and intraarticular plus subacromial injection efficacy. Eur J Anaesthesiol. 2009 Aug;26(8):689-93. doi: 10.1097/eja.0b013e32832d673e.
- Tran DQ, Elgueta MF, Aliste J, Finlayson RJ. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):32-38. doi: 10.1097/AAP.0000000000000529.
- Misamore G, Webb B, McMurray S, Sallay P. A prospective analysis of interscalene brachial plexus blocks performed under general anesthesia. J Shoulder Elbow Surg. 2011 Mar;20(2):308-14. doi: 10.1016/j.jse.2010.04.043. Epub 2010 Aug 13.
- 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.
- Warrender WJ, Syed UAM, Hammoud S, Emper W, Ciccotti MG, Abboud JA, Freedman KB. Pain Management After Outpatient Shoulder Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 2017 Jun;45(7):1676-1686. doi: 10.1177/0363546516667906. Epub 2016 Oct 13.
- Webb BG, Sallay PI, McMurray SD, Misamore GW. Comparison of Interscalene Brachial Plexus Block Performed With and Without Steroids. Orthopedics. 2016 Nov 1;39(6):e1100-e1103. doi: 10.3928/01477447-20160819-02. Epub 2016 Aug 30.
- Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688.
- Manchikanti L, Fellows B, Ailinani H, Pampati V. Therapeutic use, abuse, and nonmedical use of opioids: a ten-year perspective. Pain Physician. 2010 Sep-Oct;13(5):401-35.
- Barber FA, Herbert MA. The effectiveness of an anesthetic continuous-infusion device on postoperative pain control. Arthroscopy. 2002 Jan;18(1):76-81. doi: 10.1053/jars.2002.25976.
- Merivirta R, Kuusniemi KS, Aantaa R, Hurme SA, Aarimaa V, Leino KA. The analgesic effect of continuous subacromial bupivacaine infusion after arthroscopic shoulder surgery: a randomized controlled trial. Acta Anaesthesiol Scand. 2012 Feb;56(2):210-6. doi: 10.1111/j.1399-6576.2011.02606.x.
- Harvey GP, Chelly JE, AlSamsam T, Coupe K. Patient-controlled ropivacaine analgesia after arthroscopic subacromial decompression. Arthroscopy. 2004 May;20(5):451-5. doi: 10.1016/j.arthro.2004.03.004.
- Uquillas CA, Capogna BM, Rossy WH, Mahure SA, Rokito AS. Postoperative pain control after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016 Jul;25(7):1204-13. doi: 10.1016/j.jse.2016.01.026. Epub 2016 Apr 11.
- Shin SW, Byeon GJ, Yoon JU, Ok YM, Baek SH, Kim KH, Lee SJ. Effective analgesia with ultrasound-guided interscalene brachial plexus block for postoperative pain control after arthroscopic rotator cuff repair. J Anesth. 2014 Feb;28(1):64-9. doi: 10.1007/s00540-013-1681-x. Epub 2013 Aug 1.
- Candido KD, Sukhani R, Doty R Jr, Nader A, Kendall MC, Yaghmour E, Kataria TC, McCarthy R. Neurologic sequelae after interscalene brachial plexus block for shoulder/upper arm surgery: the association of patient, anesthetic, and surgical factors to the incidence and clinical course. Anesth Analg. 2005 May;100(5):1489-1495. doi: 10.1213/01.ANE.0000148696.11814.9F.
- Nam YS, Jeong JJ, Han SH, Park SE, Lee SM, Kwon MJ, Ji JH, Kim KS. An anatomic and clinical study of the suprascapular and axillary nerve blocks for shoulder arthroscopy. J Shoulder Elbow Surg. 2011 Oct;20(7):1061-8. doi: 10.1016/j.jse.2011.04.022. Epub 2011 Aug 11.
- Costache I, de Neumann L, Ramnanan CJ, Goodwin SL, Pawa A, Abdallah FW, McCartney CJL. The mid-point transverse process to pleura (MTP) block: a new end-point for thoracic paravertebral block. Anaesthesia. 2017 Oct;72(10):1230-1236. doi: 10.1111/anae.14004. Epub 2017 Aug 1.
- Hamilton DL, Manickam B. The Erector Spinae Plane Block. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):276. doi: 10.1097/AAP.0000000000000565. No abstract available.
- Czuczman M, Shanthanna H, Alolabi B, Moisiuk P, O'Hare T, Khan M, Forero M, Davis K, Moro J, Vanniyasingam T, Thabane L. Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Apr;99(15):e19721. doi: 10.1097/MD.0000000000019721.
- Chung F, Ritchie E, Su J. Postoperative pain in ambulatory surgery. Anesth Analg. 1997 Oct;85(4):808-16. doi: 10.1097/00000539-199710000-00017.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Agnosia
- Organic Chemicals
- Hydrocarbons
- Hydrocarbons, Cyclic
- Hydrocarbons, Aromatic
- Anilides
- Amides
- Aniline Compounds
- Amines
- Inorganic Chemicals
- Chlorine Compounds
- Behavioral Disciplines and Activities
- Catechols
- Phenols
- Benzene Derivatives
- Alcohols
- Amino Alcohols
- Ethanolamines
- Digestive System and Oral Physiological Phenomena
- Behavioral Sciences
- Biogenic Monoamines
- Biogenic Amines
- Catecholamines
- Sodium Compounds
- Dentistry
- Dental Physiological Phenomena
- Chlorides
- Hydrochloric Acid
- Bupivacaine
- Epinephrine
- Dental Occlusion
- Sodium Chloride
- Parapsychology
Other Study ID Numbers
Other Study ID Numbers
- 4668
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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