Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Shoulder Pain; Surgical Procedure, Unspecified; Diaphragmatic Paralysis
• Intervention / Treatment: Procedure: Interscalene Block; Procedure: Costoclavicular Infraclavicular Block

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Metropolitana
    • Santiago, Metropolitana, Chile, 8380456
      • Hospital Clinico Universidad de Chile

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Interscalene Block; Patients randomized to receive an intesrcalene block.	Procedure: Interscalene Block; 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.
Experimental: Costoclavicular Infraclavicular Block; Patients randomized to receive a costoclavicular infraclavicular block.	Procedure: Costoclavicular Infraclavicular Block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Static pain at 30 minutes after arrival in the PACU	Evaluated with a NRS from 0 to 10	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block performance time	Time from skin disinfection until the end of local anesthetic injection	1 hour before surgery
Intraoperative opioid requirements	Total amount of fentanyl required during general anesthesia	Intraoperative period
Static pain at 60 minutes after arrival in the PACU	Evaluated with a NRS from 0 to 10	60 minutes
Postoperative static pain at 2 hours	Evaluated with a NRS from 0 to 10	2 hours
Postoperative static pain at 3 hours	Evaluated with a NRS from 0 to 10	3 hours
Postoperative static pain at 6 hours	Evaluated with a NRS from 0 to 10	6 hours
Postoperative static pain at 12 hours	Evaluated with a NRS from 0 to 10	12 hours
Postoperative static pain at 24 hours	Evaluated with a NRS from 0 to 10	24 hours
Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block	Ultrasound diagnosed HDP	30 minutes post injection
Incidence of HDP at 30 minutes after arrival to PACU	Ultrasound diagnosed HDP	30 minutes after arrival to the PACU
Sensory and Motor block score	Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score	30 minutes post injection
Incidence of complete block	Percentage of blocks with a minimal sensorimotor composite score of 6 points out of a maximum of 8 points at 30 minutes post injection	30 minutes post injection
Procedural pain during blocks	Evaluated with a NRS from 0 to 10	1 hour before surgery
Onset time	Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points	1 hour before surgery
Surgical duration	Time between skin incision and closure	Intraoperative period
Postoperative opioid consumption	Total amount of morphine required during the first 24 hours after surgery	24 hours after surgery
Patient satisfaction	Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)	24 hours after surgery
Block- and opioid-related side effects	Incidence of side effects	1 week

Collaborators and Investigators

• Sponsor: University of Chile

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Reg Anesth Pain Med. 2010 Jul-Aug;35(4):407.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): July 6, 2018
• Study Completion (Actual): July 6, 2018

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 18, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 8, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Postoperative Shoulder Analgesia; Hemidiaphragmatic Paralysis; Alternative blocks
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Respiratory Insufficiency; Pain, Postoperative; Shoulder Pain; Paralysis; Respiratory Paralysis
• Other Study ID Numbers: 889/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No