NCT03224884

Brief 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 will compare ultrasound-guided interscalene block (ISB) and supraclavicular block 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 supraclavicular blocks will result in equivalent postoperative analgesia at 30 minutes in the PACU. The equivalence margin is set at 2 points

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

July 18, 2017

Last Update Submit

November 11, 2017

Conditions

Pain, PostoperativeShoulder PainSurgical Procedure, UnspecifiedDiaphragmatic Paralysis

Outcome Measures

Primary Outcomes (1)

  • Static pain at 30 minutes after arrival in the PACU

    Evaluated with a NRS from 0 to 10.

    30 minutes

Secondary Outcomes (18)

  • Static pain at 60 minutes after arrival in the PACU

    60 minutes

  • Postoperative static pain at 2 hours

    2 hours

  • Postoperative static pain at 3 hours

    3 hours

  • Postoperative static pain at 6 hours

    6 hours

  • Postoperative static pain at 12 hours

    12 hours

  • +13 more secondary outcomes

Study Arms (2)

Interscalene block

ACTIVE COMPARATOR

Patients randomized to receive an interscalene block .

Procedure: Interscalene block

Supraclavicular block

EXPERIMENTAL

Patients randomized to receive a supraclavicular block.

Procedure: Supraclavicular block

Interventions

Interscalene blockPROCEDURE

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.

Interscalene block
Supraclavicular blockPROCEDURE

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).

Supraclavicular block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

You may not qualify if:

  • 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 supraclavicular fossa
  • Chronic pain syndromes requiring opioid intake at home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Universidad de Chile

Santiago, Metropolitan, 8380456, Chile

Location

Related Publications (9)

  • 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.

    PMID: 19282714RESULT

  • 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.

    PMID: 2006740RESULT

  • 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.

    PMID: 26448030RESULT

  • 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: 27941477RESULT

  • 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.

    PMID: 19916254RESULT

  • 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: 20975470RESULT

  • 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: 21568985RESULT

  • 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: 16331304RESULT

  • 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: 29630033DERIVED

MeSH Terms

Conditions

Pain, PostoperativeShoulder PainRespiratory Paralysis

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsArthralgiaJoint DiseasesMusculoskeletal DiseasesRespiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesParalysisNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

July 24, 2017

Primary Completion

October 25, 2017

Study Completion

October 25, 2017

Last Updated

November 14, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)