Interscalene Block Versus Combined Infraclavicular-Anterior Suprascapular Blocks for Shoulder Surgery

NCT05444517 | Completed DMC

• 1 other identifier: OAIC 1248/22
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative analgesia after shoulder surgery remains a challenge in patients with preexisting pulmonary pathology, as interscalene brachial plexus block (ISB), the standard nerve block for shoulder surgery, carries a prohibitive risk of hemidiaphragmatic paralysis (HDP). Although several diaphragm-sparing nerve blocks have been proposed, none seems to offer equivalent analgesia to ISB while avoiding HDP altogether. For instance, even costoclavicular blocks, which initially fulfilled both requirements, were subsequently found to result in a non-negligible 5%-incidence of HDP. In this randomized trial, the authors set out to compare ISB and combined infraclavicular block-anterior suprascapular nerve blocks (ICB-ASSNB) for patients undergoing arthroscopic shoulder surgery. The authors hypothesized that ICB-ASSNB would provide equivalent postoperative analgesia to ISB 30 minutes after shoulder surgery and therefore designed the current study as an equivalence trial.

Conditions

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

Keywords

Postoperative Shoulder Analgesia; Diaphragmatic Paralysis; Alternative Blocks

Outcome Measures

Primary Outcomes (1)

• Static pain 30 minutes after arrival in the post anesthesia care unit (PACU)

  Pain intensity at rest using a numeric rating score (NRS) ranged from 0 to 10 (0 = no pain and 10 = worst imaginable pain)

  30 minutes after PACU arrival

Secondary Outcomes (21)

• Static pain 1 hour after arrival in the PACU

  1 hour after PACU arrival

• Static pain 3 hours after arrival in the PACU

  3 hours after PACU arrival

• Static pain 6 hours after arrival in the PACU

  6 hours after PACU arrival

• Static pain 12 hours after arrival in the PACU

  12 hours after PACU arrival

• Static pain 24 hours after arrival in the PACU

  24 hours after PACU arrival

Study Arms (2)

Interscalene Block

ACTIVE COMPARATOR

Patients randomized to receive an interscalene block.

Procedure: Interscalene Block

Infraclavicular-Anterior Supraescapular Nerve Blocks

EXPERIMENTAL

Patients randomized to receive a combined infraclavicular plus anterior suprascapular nerve blocks.

Procedure: Infraclavicular - Anterior Supraescapular Nerve Blocks

Interventions

Interscalene Block PROCEDURE

Ultrasound-guided brachial plexus block injecting 20 ml of bupivacaine 0.5% plus epinephrine 5 micrograms per ml in the Interscalene groove. Patients will receive dexamethasone 4 mg intravenously and an ultrasound-guided intermediate cervical plexus block (5 ml of bupivacaine 0.5% plus epinephrine 5 micrograms per ml).

Also known as: Peripheral Nerve Block

Interscalene Block

Infraclavicular - Anterior Supraescapular Nerve Blocks PROCEDURE

Ultrasound-guided combined infraclavicular-anterior suprascapular block of the brachial plexus, injecting 20 ml of bupivacaine 0.5% plus epinephrine 5 micrograms per ml dorsal to the axillary artery in the infraclavicular fossa plus an ultrasound-guided injection of 3 ml of bupivacaine 0.5% plus epinephrine 5 micrograms per ml under the omohyoid muscle. If the anterior suprascapular nerve could not be identified after five minutes of insonation time, an upper trunk block will be carried out with the same amount of local anesthetic. Patients will receive dexamethasone 4 mg intravenously and an ultrasound-guided intermediate cervical plexus block (5 ml of bupivacaine 0.5% plus epinephrine 5 micrograms per ml).

Also known as: Peripheral Nerve Block

Infraclavicular-Anterior Supraescapular Nerve Blocks

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 kg/mt2

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 or infraclavicular region
• 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, Chile

Location

Related Publications (20)

• 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

• Tran DQ, Layera S, Bravo D, Cristi-Sanchez I, Bermudez L, Aliste J. Diaphragm-sparing nerve blocks for shoulder surgery, revisited. Reg Anesth Pain Med. 2019 Sep 20:rapm-2019-100908. doi: 10.1136/rapm-2019-100908. Online ahead of print.

  PMID: 31541010 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 BACKGROUND

• Sivashanmugam T, Maurya I, Kumar N, Karmakar MK. Ipsilateral hemidiaphragmatic paresis after a supraclavicular and costoclavicular brachial plexus block: A randomised observer blinded study. Eur J Anaesthesiol. 2019 Oct;36(10):787-795. doi: 10.1097/EJA.0000000000001069.

  PMID: 31397702 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

• Vorster W, Lange CP, Briet RJ, Labuschagne BC, du Toit DF, Muller CJ, de Beer JF. The sensory branch distribution of the suprascapular nerve: an anatomic study. J Shoulder Elbow Surg. 2008 May-Jun;17(3):500-2. doi: 10.1016/j.jse.2007.10.008. Epub 2008 Feb 11.

  PMID: 18262803 BACKGROUND

• Ebraheim NA, Whitehead JL, Alla SR, Moral MZ, Castillo S, McCollough AL, Yeasting RA, Liu J. The suprascapular nerve and its articular branch to the acromioclavicular joint: an anatomic study. J Shoulder Elbow Surg. 2011 Mar;20(2):e13-7. doi: 10.1016/j.jse.2010.09.004. Epub 2010 Dec 30.

  PMID: 21194975 BACKGROUND

• Musso D, Flohr-Madsen S, Meknas K, Wilsgaard T, Ytrebo LM, Klaastad O. A novel combination of peripheral nerve blocks for arthroscopic shoulder surgery. Acta Anaesthesiol Scand. 2017 Oct;61(9):1192-1202. doi: 10.1111/aas.12948. Epub 2017 Aug 4.

  PMID: 28776638 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

• Aliste J, Bravo D, Fernandez D, Layera S, Finlayson RJ, Tran DQ. A Randomized Comparison Between Interscalene and Small-Volume Supraclavicular Blocks for Arthroscopic Shoulder Surgery. Reg Anesth Pain Med. 2018 Aug;43(6):590-595. doi: 10.1097/AAP.0000000000000767.

  PMID: 29630033 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

• Franco CD, Williams JM. Ultrasound-Guided Interscalene Block: Reevaluation of the "Stoplight" Sign and Clinical Implications. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):452-9. doi: 10.1097/AAP.0000000000000407.

  PMID: 27203394 BACKGROUND

• 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 BACKGROUND

• Maikong N, Kantakam P, Sinthubua A, Mahakkanukrauh P, Tran Q, Leurcharusmee P. Cadaveric study investigating the phrenic-sparing volume for anterior suprascapular nerve block. Reg Anesth Pain Med. 2021 Sep;46(9):769-772. doi: 10.1136/rapm-2021-102803. Epub 2021 Jun 3.

  PMID: 34083356 BACKGROUND

• Aguirre O, Tobos L, Reina MA, Sala-Blanch X. Upper trunk block: description of a supraclavicular approach of upper trunk at the points of its division. Br J Anaesth. 2016 Dec;117(6):823-824. doi: 10.1093/bja/aew366. No abstract available.

  PMID: 27956682 BACKGROUND

• Aliste J, Cristi-Sanchez I, Bermudez L, Layera S, Bravo D, Tran Q. Assessing surgical anesthesia for shoulder surgery. Reg Anesth Pain Med. 2020 Aug;45(8):675-676. doi: 10.1136/rapm-2019-100981. Epub 2019 Dec 31. No abstract available.

  PMID: 31892544 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

• 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

• Bravo D, Manzanilla M, Ramirez C, Mora D, Arancibia H, Jara A, Andahur A, Diaz C, Finlayson RJ, Aliste J, Tran Q. Randomized comparison between interscalene and combined infraclavicular-anterior suprascapular nerve blocks for arthroscopic shoulder surgery. Reg Anesth Pain Med. 2026 Mar 11:rapm-2026-107604. doi: 10.1136/rapm-2026-107604. Online ahead of print.

  PMID: 41813055 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 Officials

• Julián Aliste, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

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: Associate Professor

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 6, 2022
• Study Start: June 13, 2023
• Primary Completion: November 28, 2025
• Study Completion: November 28, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Locations

CL (1)