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Pain, PostoperativeNCT05444517

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

A study testing Interscalene Block and Infraclavicular - Anterior Supraescapular Nerve Blocks in people with Pain, Postoperative and Shoulder Pain, run by University of Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Interscalene Block and Infraclavicular - Anterior Supraescapular Nerve Blocks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChile
Study dates
13 Jun 2023to 28 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing arthroscopic shoulder surgery
  • American Society of Anesthesiologists classification 1-3
  • Body mass index between 20 and 35 kg/mt2

Who cannot join

  • 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)
Show all 10Show fewer
  • Allergy to local anesthetics (LAs)
  • Pregnancy
  • Prior surgery in the neck or infraclavicular region
  • Chronic pain syndromes requiring opioid intake at home

Trial locations and contacts

1 site in 1 country.

Chile1 site
  • Hospital Clínico Universidad de Chile

    Santiago, Santiago Metropolitan

Other trials in Chile

About this study

Official title: A Randomized Comparison Between Interscalene And Combined Infraclavicular-Anterior Suprascapular Nerve Blocks For Arthroscopic Shoulder Surgery

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.

Being tested
Interscalene Block, Infraclavicular - Anterior Supraescapular Nerve Blocks
Keywords
Postoperative Shoulder Analgesia, Diaphragmatic Paralysis, Alternative Blocks
Medical subject headings
Pain, Postoperative, Shoulder Pain, Respiratory Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interscalene BlockProcedure or surgery

    Also called Peripheral Nerve Block

    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).

  • Infraclavicular - Anterior Supraescapular Nerve BlocksProcedure or surgery

    Also called Peripheral Nerve Block

    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).

Study groups in NCT05444517
Study groupRoleWhat they receive
Interscalene BlockActive comparatorPatients randomized to receive an interscalene block.
Receives: Procedure: Interscalene Block
Infraclavicular-Anterior Supraescapular Nerve BlocksExperimentalPatients randomized to receive a combined infraclavicular plus anterior suprascapular nerve blocks.
Receives: Procedure: Infraclavicular - Anterior Supraescapular Nerve Blocks

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 30 minutes after PACU arrival

Secondary outcomes (21)
  1. Static pain 1 hour after arrival in the PACU

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

    Measured: 1 hour after PACU arrival

  2. Static pain 3 hours after arrival in the PACU

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

    Measured: 3 hours after PACU arrival

  3. Static pain 6 hours after arrival in the PACU

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

    Measured: 6 hours after PACU arrival

  4. Static pain 12 hours after arrival in the PACU

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

    Measured: 12 hours after PACU arrival

  5. Static pain 24 hours after arrival in the PACU

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

    Measured: 24 hours after PACU arrival

  6. Static pain 36 hours after arrival in the PACU

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

    Measured: 36 hours after PACU arrival

  7. Static pain 48 hours after arrival in the PACU

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

    Measured: 48 hours after PACU arrival

  8. Block performance time

    Time from skin disinfection until the end of local anesthetic injection

    Measured: 1 hour before surgery

  9. Intensity of pain during block procedure

    Evaluated with the Numeric Rating Scale for Pain. This scale is graduated from 0 to 10 points. A 0-point score represents the absence of pain, and a 10-points score represents the worst imaginable pain. Patients will be asked to rate their pain verbally with this scale. The blinded assessor will register the score reported.

    Measured: 1 hour before surgery

  10. Incidence of nerve block side effects

    Determined by the presence of paresthesia, local anesthetic systemic toxicity, vascular puncture, Horner syndrome, or hoarseness after the block.

    Measured: 0 minutes after skin disinfection to 30 minutes after the nerve block

  11. Sensory and motor block score

    The sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 14-point composite score that encompasses the sensory functions of the axillary and supraclavicular nerves as well as the motor functions of the axillary, suprascapular, subscapular and lateral pectoral nerves

    Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch.

    The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.

    Successful blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 12 points out of 14, with a sensory score of at least 3 points (out of 4 points).

    Measured: 30 minutes after the ending time of local anesthetic injection

  12. Block onset time

    Time required to reach a minimal sensorimotor composite score of 12 points out of a maximum of 14 points. The sensorimotor score is described in outcome 12.

    Measured: 1 hour before surgery

  13. Basal diaphragmatic function

    Diaphragmatic function evaluated before the nerve block

    Measured: 1 hour before surgery

  14. Incidence of hemidiaphragmatic paralysis (HDP) at 30 minutes after interscalene or infraclavicular-suprascapular block

    HDP will be defined as the absence of diaphragmatic motion during normal respiration coupled with absent or (paradoxical) cranial diaphragmatic movement when the patient forcefully sniffs

    Measured: 30 minutes after the ending time of local anesthetic injection

  15. Incidence of HDP 30 minutes after PACU arrival

    HDP will be defined as the absence of diaphragmatic motion during normal respiration coupled with absent or (paradoxical) cranial diaphragmatic movement when the patient forcefully sniffs

    Measured: 30 minutes after PACU arrival

  16. Duration of surgery

    Time between skin incision and closure (min)

    Measured: 4 hours after skin incision

  17. Postoperative opioid related side effects

    Presence of postoperative nausea, vomiting, pruritus, urinary retention, respiratory depression.

    Measured: 48 hours after PACU arrival

  18. Intraoperative opioid requirements

    Total amount of fentanyl required during general anesthesia

    Measured: Intraoperative period

  19. Postoperative opioid consumption

    Total amount of morphine required during the first 48 hours after surgery

    Measured: 48 hours after PACU arrival

  20. Patient satisfaction

    Patient satisfaction at 24 hours using a 0-10 scale (0 = not satisfied; 10 = very satisfied)

    Measured: 24 hours after PACU arrival

  21. Persistent neurologic deficit

    Presence of persistent sensory or motor postoperative deficit. The patients will be contacted by telephone and inquired about any sensory or motor deficit in the operated extremity.

    Measured: 7 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2022
  2. Study start13 Jun 2023
  3. Primary completion28 Nov 2025
  4. Study completion28 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444517
Sponsor's protocol ID
OAIC 1248/22
Status last verified
Dec 2025
First submitted
28 Jun 2022
Last updated
29 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27941477
  • 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.

    PubMed 31541010
  • 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.

    PubMed 30635497
  • 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.

    PubMed 31397702
  • 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.

    PubMed 12606927
  • 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.

    PubMed 29270914
  • 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.

    PubMed 18262803
  • 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.

    PubMed 21194975
  • 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.

    PubMed 28776638
  • 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.

    PubMed 20975470
  • 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.

    PubMed 29630033
  • 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.

    PubMed 21568985
  • 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.

    PubMed 27203394
  • 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.

    PubMed 20048654
  • 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.

    PubMed 34083356

Questions about this trial

What is this clinical trial studying?

A study testing Interscalene Block and Infraclavicular - Anterior Supraescapular Nerve Blocks in people with Pain, Postoperative and Shoulder Pain, run by University of Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Static pain 30 minutes after arrival in the post anesthesia care unit (PACU) (time frame: 30 minutes after PACU arrival). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05444517, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.

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