Interscalene Block Versus Infraclavicular Block Plus Suprascapular Nerve Block

NCT02993939 | Completed DMC

• 1 other identifier: 853/16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Despite their reliability and efficacy for shoulder surgery analgesia, above clavicle brachial plexus blocks are related with phrenic nerve palsy and diaphragm paralysis that may not be tolerated in patients with chronic pulmonary disease. This RCT will compare the classic Interscalene block with combined infraclavicular block plus suprascapular nerve block in patients going for arthroscopic shoulder surgery. Main outcome is static pain in the recovery room measured with NRS. Secondary outcomes are pain at 12 and 24 hrs and incidence of diaphragmatic paralysis.

Conditions

Shoulder Injury

Outcome Measures

Primary Outcomes (1)

• Static Pain using numeric scale 0-10

  30 minutes after arrival to PACU

Secondary Outcomes (3)

• Static Pain using numeric scale 0-10

  12 hrs after arrival to PACU

• Diaphragm paralysis incidence

  30 minutes after block

• Static Pain using numeric scale 0-10

  24 hrs

Study Arms (2)

Interscalene block

ACTIVE COMPARATOR

Ultrasound guided Brachial plexus block injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml, in the Interscalene groove.

Procedure: Interscalene block

Diaphragm-sparing block

EXPERIMENTAL

Ultrasound guided combinated infraclavicular-Suprascapular block of the braquial plexus, injecting 20 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml dorsal to the axillary artery in the infraclavicular fossa plus an Ultrasound guided injection of 10 ml of levobupivacaine 0,25% plus epinephrine 5 micrograms per ml in the suprascapular fossa.

Procedure: Infraclavicular-suprascapular block

Interventions

Interscalene block PROCEDURE

Ultrasound guided single shot block above the clavicle

Interscalene block

Infraclavicular-suprascapular block PROCEDURE

Combined block of nerves far away from phrenic nerve

Diaphragm-sparing block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 years
• American Society of Anesthesiologists classification 1-3
• body mass index between 20 and 30

You may not qualify if:

• adults who are unable to give their own consent
• pre-existing neuropathy (assessed by history and physical examination)
• coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
• obstructive or restrictive pulmonary disease (assessed by history and physical examination)
• renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
• hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
• allergy to local anesthetics (LAs)
• pregnancy
• prior surgery in the neck, infraclavicular region or suprascapular fossa
• chronic pain syndromes requiring opioid intake at home

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clinico Universidad de Chile

Santiago, Metropolitan, 8380456, Chile

Location

Related Publications (11)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Chan CW, Peng PW. Suprascapular nerve block: a narrative review. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):358-73. doi: 10.1097/AAP.0b013e3182204ec0.

  PMID: 21654552 RESULT

• Tran DQ, Bertini P, Zaouter C, Munoz L, Finlayson RJ. A prospective, randomized comparison between single- and double-injection ultrasound-guided infraclavicular brachial plexus block. Reg Anesth Pain Med. 2010 Jan-Feb;35(1):16-21. doi: 10.1097/AAP.0b013e3181c7717c.

  PMID: 20048654 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Dhir S, Sondekoppam RV, Sharma R, Ganapathy S, Athwal GS. A Comparison of Combined Suprascapular and Axillary Nerve Blocks to Interscalene Nerve Block for Analgesia in Arthroscopic Shoulder Surgery: An Equivalence Study. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):564-71. doi: 10.1097/AAP.0000000000000436.

  PMID: 27380105 RESULT

• 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 DERIVED

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Clinical Instructor

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 15, 2016
• Study Start: December 1, 2016
• Primary Completion: April 28, 2017
• Study Completion: May 1, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)