ClinicalTrials.gg
CompletedNCT03411343Updated Jul 10, 2018

Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

An interventional study of Interscalene Block and Costoclavicular Infraclavicular Block in Pain, Postoperative, Shoulder Pain and Surgical Procedure, Unspecified, sponsored by University of Chile. Completed at 1 site in Chile. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-07-10.

Sponsored by University of Chile · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Pain, Postoperative by University of Chile — 1 open to participants now, 1 under way, none of them phase 3. Pain, Postoperative · University of Chile.

Enrollment
8th of 11
44 · median 50
Started
2018
with 2 others
No phase
10 of 12
1 open now
Registered
3rd of 12
by date

Among the 12 studies in Pain, Postoperative by University of Chile, this one is the 8th largest by enrollment of the 11 interventional ones, is one of 3 that started in 2018, is one of 10 with no phase, and was the 3rd registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phasethis study10 · 1 open
Observational1 · 0 open
Phase 41 · 0 open

By the year they started

First in 2015; this study’s year is marked. 3 started in 2018.

Size and results

Median enrollment 50 across the 11 interventional studies, 57 across the 1 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 12 studies in Pain, Postoperative by University of Chile, or all of them as a file.
02

Study 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.

03

Conditions studied

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

Keywords

  • Postoperative Shoulder Analgesia
  • Hemidiaphragmatic Paralysis
  • Alternative blocks
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing arthroscopic shoulder surgery
  • classification 1-3
  • between 20 and 35

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    Interscalene Block

    Patients randomized to receive an intesrcalene block.

    Procedure: Interscalene Block

  • Experimental
    Costoclavicular Infraclavicular Block

    Patients randomized to receive a costoclavicular infraclavicular block.

    Procedure: Costoclavicular Infraclavicular Block

Interventions

  • ProcedureInterscalene 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.

  • ProcedureCostoclavicular 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.

06

What researchers measure

Primary outcomes

  1. Static pain at 30 minutes after arrival in the PACU

    Evaluated with a NRS from 0 to 10

    Time frame: 30 minutes

Secondary outcomes

  1. Static pain at 60 minutes after arrival in the PACU

    Evaluated with a NRS from 0 to 10

    Time frame: 60 minutes

  2. Postoperative static pain at 2 hours

    Evaluated with a NRS from 0 to 10

    Time frame: 2 hours

  3. Postoperative static pain at 3 hours

    Evaluated with a NRS from 0 to 10

    Time frame: 3 hours

  4. Postoperative static pain at 6 hours

    Evaluated with a NRS from 0 to 10

    Time frame: 6 hours

  5. Postoperative static pain at 12 hours

    Evaluated with a NRS from 0 to 10

    Time frame: 12 hours

  6. Postoperative static pain at 24 hours

    Evaluated with a NRS from 0 to 10

    Time frame: 24 hours

  7. Incidence of HDP at 30 minutes after interscalene or costoclavicular infraclavicular block

    Ultrasound diagnosed HDP

    Time frame: 30 minutes post injection

  8. Incidence of HDP at 30 minutes after arrival to PACU

    Ultrasound diagnosed HDP

    Time frame: 30 minutes after arrival to the PACU

  9. Block performance time

    Time from skin disinfection until the end of local anesthetic injection

    Time frame: 1 hour before surgery

  10. Sensory and Motor block score

    Sensorimotor block assessed every 5 minutes until 30 minutes using a 8-point composite score

    Time frame: 30 minutes post injection

  11. 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

    Time frame: 30 minutes post injection

  12. Procedural pain during blocks

    Evaluated with a NRS from 0 to 10

    Time frame: 1 hour before surgery

  13. Onset time

    Time required to reach a minimal sensorimotor composite score of 6 points out of a maximum of 8 points

    Time frame: 1 hour before surgery

  14. Intraoperative opioid requirements

    Total amount of fentanyl required during general anesthesia

    Time frame: Intraoperative period

  15. Surgical duration

    Time between skin incision and closure

    Time frame: Intraoperative period

  16. Postoperative opioid consumption

    Total amount of morphine required during the first 24 hours after surgery

    Time frame: 24 hours after surgery

  17. Patient satisfaction

    Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)

    Time frame: 24 hours after surgery

  18. Block- and opioid-related side effects

    Incidence of side effects

    Time frame: 1 week

07

Study locations

1 site
  • Hospital Clínico Universidad de Chile
    Santiago, Metropolitana 8380456, Chile
08

References and documents

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. Erratum In: Reg Anesth Pain Med. 2010 Jul-Aug;35(4):407. PubMed 19282714 ↗
  • 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. PubMed 2006740 ↗
  • 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 ↗
  • 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. PubMed 28205117 ↗
  • 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. PubMed 16331304 ↗
  • 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 ↗
  • 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. PubMed 25899958 ↗
  • 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 ↗
  • 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. PubMed 27396247 ↗
  • 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. PubMed 19535272 ↗
  • 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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03411343
Responsible party
Julian Aliste (Clinical Instructor, Department of Anesthesia, University of Chile) — Principal investigator
First posted
Jan 26, 2018
Start date
Apr 9, 2018
Primary completion
Jul 6, 2018
Completion
Jul 6, 2018
Last update
Jul 10, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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