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Pain, PostoperativeNCT03411343

Interscalene Block Versus Costoclavicular Block for Shoulder Surgery

A study testing Interscalene Block and Costoclavicular Infraclavicular Block 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

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Interscalene Block and Costoclavicular Infraclavicular Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChile
Study dates
9 Apr 2018to 6 Jul 2018
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

Who cannot join

  • Adults who are unable to give their own consent
  • Pre-existing neuropathy
  • Coagulopathy
  • Obstructive or restrictive pulmonary disease
  • Renal failure
  • Hepatic failure
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Hospital Clínico Universidad de Chile

    Santiago, Santiago Metropolitan, 8380456

Other trials in Chile

About this study

Official title: A Randomized Comparison Between Interscalene and Costoclavicular Infraclavicular Brachial Plexus Blocks For Arthroscopic Shoulder Surgery

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.

Being tested
Interscalene Block, Costoclavicular Infraclavicular Block
Keywords
Postoperative Shoulder Analgesia, Hemidiaphragmatic 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

    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.

  • Costoclavicular Infraclavicular BlockProcedure or surgery

    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.

Study groups in NCT03411343
Study groupRoleWhat they receive
Interscalene BlockActive comparatorPatients randomized to receive an intesrcalene block.
Receives: Procedure: Interscalene Block
Costoclavicular Infraclavicular BlockExperimentalPatients randomized to receive a costoclavicular infraclavicular block.
Receives: Procedure: Costoclavicular Infraclavicular Block

What is being measured

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

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

    Evaluated with a NRS from 0 to 10

    Measured: 30 minutes

Secondary outcomes (18)

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

    Evaluated with a NRS from 0 to 10

    Measured: 60 minutes

  2. Postoperative static pain at 2 hours

    Evaluated with a NRS from 0 to 10

    Measured: 2 hours

  3. Postoperative static pain at 3 hours

    Evaluated with a NRS from 0 to 10

    Measured: 3 hours

  4. Postoperative static pain at 6 hours

    Evaluated with a NRS from 0 to 10

    Measured: 6 hours

  5. Postoperative static pain at 12 hours

    Evaluated with a NRS from 0 to 10

    Measured: 12 hours

  6. Postoperative static pain at 24 hours

    Evaluated with a NRS from 0 to 10

    Measured: 24 hours

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

    Ultrasound diagnosed HDP

    Measured: 30 minutes post injection

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

    Ultrasound diagnosed HDP

    Measured: 30 minutes after arrival to the PACU

  9. Block performance time

    Time from skin disinfection until the end of local anesthetic injection

    Measured: 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

    Measured: 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

    Measured: 30 minutes post injection

  12. Procedural pain during blocks

    Evaluated with a NRS from 0 to 10

    Measured: 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

    Measured: 1 hour before surgery

  14. Intraoperative opioid requirements

    Total amount of fentanyl required during general anesthesia

    Measured: Intraoperative period

  15. Surgical duration

    Time between skin incision and closure

    Measured: Intraoperative period

  16. Postoperative opioid consumption

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

    Measured: 24 hours after surgery

  17. Patient satisfaction

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

    Measured: 24 hours after surgery

  18. Block- and opioid-related side effects

    Incidence of side effects

    Measured: 1 week

Timeline

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

  1. First posted26 Jan 2018
  2. Study start9 Apr 2018
  3. Primary completion6 Jul 2018
  4. Study completion6 Jul 2018

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
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03411343
Sponsor's protocol ID
889/17
Status last verified
Jul 2018
First submitted
5 Jan 2018
Last updated
10 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing Interscalene Block and Costoclavicular Infraclavicular Block 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 10 Jul 2018. 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 at 30 minutes after arrival in the PACU (time frame: 30 minutes). 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 NCT03411343, which also lists 12 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 10 Jul 2018.

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