Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

• ClinicalTrials.gov Identifier: NCT03411343
• Recruitment Status: Completed
• First Posted: January 26, 2018
• Last Update Posted: July 10, 2018
• Sponsor: University of Chile
• Information provided by (Responsible Party): Julian Aliste, University of Chile

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative; Shoulder Pain; Surgical Procedure, Unspecified; Diaphragmatic Paralysis	Procedure: Interscalene Block; Procedure: Costoclavicular Infraclavicular Block	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Care Provider, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery
• Actual Study Start Date: April 9, 2018
• Actual Primary Completion Date: July 6, 2018
• Actual Study Completion Date: July 6, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Static pain at 30 minutes after arrival in the PACU [ Time Frame: 30 minutes ]
   Evaluated with a NRS from 0 to 10

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Chile

Hospital Clínico Universidad de Chile

Santiago, Metropolitana, Chile, 8380456

Sponsors and Collaborators

University of Chile

More Information

Publications:

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

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.

Martínez 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.

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.

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.

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. Epub 2005 Dec 6.

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.

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.

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.

Flohr-Madsen S, Ytrebø LM, Valen K, Wilsgaard T, Klaastad Ø. 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.

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.

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

Aliste J, Bravo D, Layera S, Fernández D, Jara Á, 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. pii: rapm-2018-100055. doi: 10.1136/rapm-2018-100055. [Epub ahead of print]

• Responsible Party: Julian Aliste, Clinical Instructor, Department of Anesthesia, University of Chile
• ClinicalTrials.gov Identifier: NCT03411343
• Other Study ID Numbers: 889/17
• First Posted: January 26, 2018
• Last Update Posted: July 10, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Julian Aliste, University of Chile:

Postoperative Shoulder Analgesia; Hemidiaphragmatic Paralysis; Alternative blocks

Additional relevant MeSH terms:

Shoulder Pain; Respiratory Paralysis; Paralysis; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Nervous System Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases