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Pain, PostoperativeNCT03224884

Interscalene Block Versus Supraclavicular Block for Shoulder Surgery

A study testing Interscalene block and Supraclavicular 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 Supraclavicular block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChile
Study dates
24 Jul 2017to 25 Oct 2017
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 supraclavicular fossa
  • Chronic pain syndromes requiring opioid intake at home

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Hospital Clinico Universidad de Chile

    Santiago, Metropolitan, 8380456

Other trials in Chile

About this study

Official title: A Randomized Comparison Between Interscalene and Supraclavicular 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 will compare ultrasound-guided interscalene block (ISB) and supraclavicular block in patients undergoing arthroscopic shoulder surgery.

Read more

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 supraclavicular 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, Supraclavicular block
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

    Ultrasound guided brachial plexus block injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in the interscalene groove, under the prevertebral fascia.

  • Supraclavicular blockProcedure or surgery

    Ultrasound guided brachial plexus injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL (3 mL in the "corner pocket" followed by 17 mL posterolateral to the brachial plexus).

Study groups in NCT03224884
Study groupRoleWhat they receive
Interscalene blockActive comparatorPatients randomized to receive an interscalene block .
Receives: Procedure: Interscalene block
Supraclavicular blockExperimentalPatients randomized to receive a supraclavicular block.
Receives: Procedure: Supraclavicular 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 supraclavicular 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 PACU

  9. Block performance time

    Time from skin desinfection until the end of local anesthetic injection.

    Measured: 1 hour before surgery

  10. Sensory and Motor block

    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 posted21 Jul 2017
  2. Study start24 Jul 2017
  3. Primary completion25 Oct 2017
  4. Study completion25 Oct 2017

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03224884
Sponsor's protocol ID
888/17
Status last verified
Nov 2017
First submitted
18 Jul 2017
Last updated
14 Nov 2017
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

  • Ryu T, Kil BT, Kim JH. Comparison Between Ultrasound-Guided Supraclavicular and Interscalene Brachial Plexus Blocks in Patients Undergoing Arthroscopic Shoulder Surgery: A Prospective, Randomized, Parallel Study. Medicine (Baltimore). 2015 Oct;94(40):e1726. doi: 10.1097/MD.0000000000001726.

    PubMed 26448030

  • 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

  • Renes SH, Spoormans HH, Gielen MJ, Rettig HC, van Geffen GJ. Hemidiaphragmatic paresis can be avoided in ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):595-9. doi: 10.1097/aap.0b013e3181bfbd83.

    PubMed 19916254

  • 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

  • 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

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Interscalene block and Supraclavicular 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 14 Nov 2017. 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 NCT03224884, which also lists 9 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 14 Nov 2017; AzTrials last refreshed its copy on 31 Oct 2026.

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