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

NCT03691922 | Completed

• 1 other identifier: 4668
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroscopic Shoulder Surgery

Keywords

Shoulder; Pain; Erector Spinae Plane block; Surgery; Arthroscopy; Periarticular infiltration; Post-Anesthesia Care Unit; Day Surgery Unit; Regional anesthesia; Analgesia

Outcome Measures

Primary Outcomes (1)

• Recovery room resting pain score

  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 Outcomes (10)

• Day Surgery Unit resting pain score

  At 5 hours post-operatively

• Pain scores with movement

  At 30 minutes post-admission to recovery room and 5 hours post-operatively

• Opioid usage

  At 2 hours post-operatively and 5 hours post-operatively

• Incidence of moderate to severe postoperative nausea-vomiting

  At 2 hours post-operatively and 5 hours post-operatively

• Incidence of moderate to severe itching

  At 2 hours post-operatively and 5 hours post-operatively

Study Arms (2)

ESP Block

ACTIVE COMPARATOR

Preoperative US guided active Erector Spinae Plane (ESP) block and a saline PAI

Procedure: Erector Spinae Plane (ESP) Block

PAI with LA

OTHER

Preoperative US guided ESP blockade with saline and an active Periarticular Infiltration (PAI)

Procedure: Periarticular Infiltration (PAI)

Interventions

Erector Spinae Plane (ESP) Block PROCEDURE

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

Also known as: 0.25% bupivacaine with 5 mcg/mL of epinephrine & PAI with 30 mL of saline

ESP Block

Periarticular Infiltration (PAI) PROCEDURE

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

Also known as: ESP block with 30 mL of saline & PAI with 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine

PAI with LA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (20)

• 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.

  PMID: 19593887 BACKGROUND

• 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.

  PMID: 20859312 BACKGROUND

• 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.

  PMID: 9322460 BACKGROUND

• 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.

  PMID: 11774146 BACKGROUND

• 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.

  PMID: 22236345 BACKGROUND

• 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.

  PMID: 15122133 BACKGROUND

• 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.

  PMID: 27729319 BACKGROUND

• 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.

  PMID: 27079219 BACKGROUND

• 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.

  PMID: 23903900 BACKGROUND

• 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.

  PMID: 20708419 BACKGROUND

• 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.

  PMID: 27575034 BACKGROUND

• 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.

  PMID: 15845712 BACKGROUND

• 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.

  PMID: 21839653 BACKGROUND

• 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.

  PMID: 28762464 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 28207652 BACKGROUND

• 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.

  PMID: 29134518 BACKGROUND

• 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.

  PMID: 27941477 BACKGROUND

• 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.

  PMID: 25822923 BACKGROUND

• 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.

  PMID: 32282729 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Parapsychology; Dental Occlusion; Bupivacaine; Epinephrine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: October 2, 2018
• Study Start: July 6, 2019
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2021
• Last Updated: February 24, 2021

Record last verified: 2020-08

Locations

CA (1)