Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

NCT03411343 | Completed DMC

• 1 other identifier: 889/17
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Interscalene brachial plexus block constitutes the analgesic criterion standard for shoulder surgery. However, it is associated with a high incidence of hemidiaphragmatic paralysis (HDP) that may not be tolerated by patients with chronic pulmonary disease. This randomized controlled trial (RCT) will compare ultrasound-guided interscalene block (ISB) and costoclavicular infraclavicular block (CCICB) in patients undergoing arthroscopic shoulder surgery. The main outcome is static pain at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rate scale (NRS) from 0 to 10. Our research hypothesis is that interscalene and costoclavicular infraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points.

Conditions

Pain, Postoperative; Shoulder Pain; Surgical Procedure, Unspecified; Diaphragmatic Paralysis

Keywords

Postoperative Shoulder Analgesia; Hemidiaphragmatic Paralysis; Alternative blocks

Outcome Measures

Primary Outcomes (1)

• Static pain at 30 minutes after arrival in the PACU

  Evaluated with a NRS from 0 to 10

  30 minutes

Secondary Outcomes (18)

• Static pain at 60 minutes after arrival in the PACU

  60 minutes

• Postoperative static pain at 2 hours

  2 hours

• Postoperative static pain at 3 hours

  3 hours

• Postoperative static pain at 6 hours

  6 hours

• Postoperative static pain at 12 hours

  12 hours

Study Arms (2)

Interscalene Block

ACTIVE COMPARATOR

Patients randomized to receive an intesrcalene block.

Procedure: Interscalene Block

Costoclavicular Infraclavicular Block

EXPERIMENTAL

Patients randomized to receive a costoclavicular infraclavicular block.

Procedure: Costoclavicular Infraclavicular Block

Interventions

Interscalene Block PROCEDURE

Injection with ultrasound guidance of 20mL of levobupivacaine 0.5% with 5 micrograms of epinephrine per mL in the interscalene groove of the brachial plexus.

Interscalene Block

Costoclavicular Infraclavicular Block PROCEDURE

Ultrasound guided brachial plexus block injecting 20mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in between the cords of the brachial plexus at the costoclavicular infraclavicular space.

Costoclavicular Infraclavicular Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing arthroscopic shoulder surgery
• American Society of Anesthesiologists classification 1-3
• Body mass index between 20 and 35

You may not qualify if:

• Adults who are unable to give their own consent
• Pre-existing neuropathy
• Coagulopathy
• Obstructive or restrictive pulmonary disease
• Renal failure
• Hepatic failure
• Allergy to local anesthetics
• Pregnancy
• Prior surgery in the corresponding side of the neck or infraclavicular fossa
• Chronic pain syndromes requiring opioid intake at home

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

Location

Related Publications (12)

• Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.

  PMID: 19282714 BACKGROUND

• Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.

  PMID: 2006740 BACKGROUND

• Martinez J, Sala-Blanch X, Ramos I, Gomar C. Combined infraclavicular plexus block with suprascapular nerve block for humeral head surgery in a patient with respiratory failure: an alternative approach. Anesthesiology. 2003 Mar;98(3):784-5. doi: 10.1097/00000542-200303000-00031. No abstract available.

  PMID: 12606927 BACKGROUND

• Aliste J, Bravo D, Finlayson RJ, Tran DQ. A randomized comparison between interscalene and combined infraclavicular-suprascapular blocks for arthroscopic shoulder surgery. Can J Anaesth. 2018 Mar;65(3):280-287. doi: 10.1007/s12630-017-1048-0. Epub 2017 Dec 19.

  PMID: 29270914 BACKGROUND

• Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15.

  PMID: 28205117 BACKGROUND

• Lloyd T, Tang YM, Benson MD, King S. Diaphragmatic paralysis: the use of M mode ultrasound for diagnosis in adults. Spinal Cord. 2006 Aug;44(8):505-8. doi: 10.1038/sj.sc.3101889. Epub 2005 Dec 6.

  PMID: 16331304 BACKGROUND

• Tran DQ, Dugani S, Finlayson RJ. A randomized comparison between ultrasound-guided and landmark-based superficial cervical plexus block. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):539-43. doi: 10.1097/AAP.0b013e3181faa11c.

  PMID: 20975470 BACKGROUND

• Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.

  PMID: 25899958 BACKGROUND

• Spence BC, Beach ML, Gallagher JD, Sites BD. Ultrasound-guided interscalene blocks: understanding where to inject the local anaesthetic. Anaesthesia. 2011 Jun;66(6):509-14. doi: 10.1111/j.1365-2044.2011.06712.x.

  PMID: 21568985 BACKGROUND

• Flohr-Madsen S, Ytrebo LM, Valen K, Wilsgaard T, Klaastad O. A randomised placebo-controlled trial examining the effect on hand supination after the addition of a suprascapular nerve block to infraclavicular brachial plexus blockade. Anaesthesia. 2016 Aug;71(8):938-47. doi: 10.1111/anae.13504.

  PMID: 27396247 BACKGROUND

• Tashjian RZ, Deloach J, Porucznik CA, Powell AP. Minimal clinically important differences (MCID) and patient acceptable symptomatic state (PASS) for visual analog scales (VAS) measuring pain in patients treated for rotator cuff disease. J Shoulder Elbow Surg. 2009 Nov-Dec;18(6):927-32. doi: 10.1016/j.jse.2009.03.021. Epub 2009 Jun 16.

  PMID: 19535272 BACKGROUND

• Aliste J, Bravo D, Layera S, Fernandez D, Jara A, Maccioni C, Infante C, Finlayson RJ, Tran DQ. Randomized comparison between interscalene and costoclavicular blocks for arthroscopic shoulder surgery. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100055. doi: 10.1136/rapm-2018-100055. Online ahead of print.

  PMID: 30635497 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain; Respiratory Paralysis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor, Department of Anesthesia

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 26, 2018
• Study Start: April 9, 2018
• Primary Completion: July 6, 2018
• Study Completion: July 6, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)