NCT02397330

Brief Summary

Interscalene brachial plexus block is the gold standard for perioperative pain management in shoulder surgery. However, this technique would have side effects and potential serious complications. The aim of this study is to compare between the combination of ultrasound guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene brachial plexus block for post operative analgesia after shoulder instability surgery with latarjet procedure.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Status
unknown

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

March 9, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

1 month

First QC Date

March 9, 2015

Last Update Submit

March 23, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analogic Scale

    quality of postoperative analgesia

    until 48 hours postoperative

Secondary Outcomes (4)

  • time to perform the blocks

    up to 5 minutes

  • patient satisfaction

    48 hours post performing nerves blocks

  • occurrence of complications

    48 hours post performing nerves blocks

  • total dose of morphine consumption in mg

    during 48 hours post operative

Study Arms (2)

group BIS

ACTIVE COMPARATOR

scheduled for ultrasound guided interscalene blockade with 30 ml of bupivacaine 0.25%

Drug: bupivacaineDevice: ultrasoundDrug: morphine

group BS

EXPERIMENTAL

scheduled for selective blockade of the ultrasound guided suprascapular (15 ml bupivacaine 0.25%) and supraclavicular (15 ml bupivacaine 0.25%) nerves blocks

Drug: bupivacaineDevice: ultrasoundDrug: morphine

Interventions

group BISgroup BS

ultrasound guided nerve blocks

group BISgroup BS
group BISgroup BS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status I-III
  • years of age, inclusive
  • shoulder surgery (LATARJET technique)

You may not qualify if:

  • contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
  • existing neurological deficit
  • pregnancy
  • history of neck surgery or radiotherapy
  • severe respiratory disease
  • inability to understand the informed consent and demands of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Trabelsi W, Ben Gabsia A, Lebbi A, Sammoud W, Labbene I, Ferjani M. Suprascapular block associated with supraclavicular block: An alternative to isolated interscalene block for analgesia in shoulder instability surgery? Orthop Traumatol Surg Res. 2017 Feb;103(1):77-83. doi: 10.1016/j.otsr.2016.10.012. Epub 2016 Dec 2.

MeSH Terms

Interventions

BupivacaineUltrasonographyMorphine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor, MD

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 24, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 24, 2015

Record last verified: 2015-03