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Comparison of an Interscalene Nerve Block With or Without Stellate Ganglion Block for Shoulder Surgery

Primary Purpose

Anesthesia, Regional

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levobupivacaine
NaCl 0.9%
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Regional

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA class 1 to 3
  • Need for shoulder surgery

Exclusion Criteria:

  • Mental retardation
  • allergy for local anesthetics
  • a medical reason as a contra-indication for NSAID use
  • Diabetes mellitus
  • peripheral neuropathy
  • chronic analgetic use
  • chronic pain patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo

    Stellate ganglion block

    Arm Description

    NaCl 0.9% 3ml perineural stellate ganglion injection

    Levobupivacaine 3ml perineural stellate ganglion injection

    Outcomes

    Primary Outcome Measures

    Duration of analgesia
    The duration of analgesia assessed with quantitative sensory testing

    Secondary Outcome Measures

    Need for rescue analgesia
    The timing of the need for rescue analgesia as requested by the patient
    Duration of motor block
    The duration of a motor block

    Full Information

    First Posted
    August 11, 2016
    Last Updated
    October 26, 2016
    Sponsor
    University Hospital, Antwerp
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02879916
    Brief Title
    Comparison of an Interscalene Nerve Block With or Without Stellate Ganglion Block for Shoulder Surgery
    Official Title
    Comparison of the Analgesic Effect of Levobupivacaine 0.5% Via Interscalene Nerve Block or Via Interscalene Nerve Block Combined With a Stellate Ganglion Block in Patients Undergoing Shoulder Arthroscopy With General Anaesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Antwerp

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study describes the difference of analgesic effect of levobupivacaine 0.5% administered through an interscalene nerve block with or without a stellate ganglion block. The length of the analgesic effect is our primary outcome parameter. Half of the recruited patients will receive a stellate ganglion block and half of the patients won't.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia, Regional

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    NaCl 0.9% 3ml perineural stellate ganglion injection
    Arm Title
    Stellate ganglion block
    Arm Type
    Active Comparator
    Arm Description
    Levobupivacaine 3ml perineural stellate ganglion injection
    Intervention Type
    Drug
    Intervention Name(s)
    Levobupivacaine
    Intervention Description
    Inject 3ml of levobupavacaine into the stellate ganglion area
    Intervention Type
    Drug
    Intervention Name(s)
    NaCl 0.9%
    Intervention Description
    Inject 3ml of NaCl 0.9% into the stellate ganglion area
    Primary Outcome Measure Information:
    Title
    Duration of analgesia
    Description
    The duration of analgesia assessed with quantitative sensory testing
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Need for rescue analgesia
    Description
    The timing of the need for rescue analgesia as requested by the patient
    Time Frame
    24 hours
    Title
    Duration of motor block
    Description
    The duration of a motor block
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA class 1 to 3 Need for shoulder surgery Exclusion Criteria: Mental retardation allergy for local anesthetics a medical reason as a contra-indication for NSAID use Diabetes mellitus peripheral neuropathy chronic analgetic use chronic pain patients
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luc Sermeus, MD
    Organizational Affiliation
    Consultant
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of an Interscalene Nerve Block With or Without Stellate Ganglion Block for Shoulder Surgery

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