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Comparison of the Analgesic Effect of Different Local Anesthetics in Interscalene Nerve Block for Shoulder Surgery

Primary Purpose

Other Peripheral Nerve Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ropivacaine 0.75%
Levobupivacaine 0.5%
Levobupivacaine 0.5% + epinephrin 1/200000
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Other Peripheral Nerve Disease focused on measuring Peripheral nerve block

Eligibility Criteria

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

Inclusion Criteria:

  • American Society of Anesthesia class I or II
  • Scheduled for shoulder surgery

Exclusion Criteria:

  • Mental retardation
  • Allergy for local anesthetics
  • NSAID intolerance or contraindicated
  • Diabetes mellitus
  • Chronic use of pain killers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Ropivacaine 0.75%

    Levobupivacaine 0.5%

    Levobupivacaine 0.5% + epinephrin

    Arm Description

    The investigators administer 5 milliliters of Ropivacaine 0.75% in the inter scalene space

    The investigators administer 5ml of Levobupivacaine 0.5% in the inter scalene space

    The investigators administer 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in the inter scalene space

    Outcomes

    Primary Outcome Measures

    Length of nerve block measured in longitudinally recorded significant changes in sensory thresholds using quantitative sensory testing
    Length of difference in cold and heat pain and sensation measured with quantitative sensory testing

    Secondary Outcome Measures

    Need for rescue drugs, as requested by the patient after surgery
    Motor activity block, longitudinally recorded inability to move the blocked limb
    Intensity of nerve block, recorded as maximal changes in sensory thresholds using quantitative sensory testing
    The difference in threshold of cold and heat pain and sensation measured with quantitative sensory testing

    Full Information

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

    Unique Protocol Identification Number
    NCT02691442
    Brief Title
    Comparison of the Analgesic Effect of Different Local Anesthetics in Interscalene Nerve Block for Shoulder Surgery
    Official Title
    Comparison of the Analgesic Effect of the Local Anesthetics Ropicacaine, Levobupivacaine, and Levobupivacaine + Epinephrin Via Interscalene Nerve Block in Patients Undergoing Shoulder Arthroscopy Under General Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    April 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
    Several reports have compared the duration of action of levobupivacaine and ropivacaine as local anesthetic. The most widely used method for sensory function evaluation is though means of a pinprick test. The investigators want to use the novel method of Quantitative Sensory Testing to better evaluate the anesthetic activity. This method used hot and cold sensation to assess small nerve fiber function. The investigators will assess the duration of action of different drugs when used in an inter scalene nerve block in patients scheduled for shoulder surgery.
    Detailed Description
    This study aims to compare the length of the analgesic effect of different local anesthesic solutions, used in an interscalene nerve block. This will be objectified by measuring the changes in small nerve functioning, using quantative sensory testing. Based on the results of a previous study, the investigators reduce the dose of the administered local anesthetic, expecting a similar length of action using these smaller doses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Other Peripheral Nerve Disease
    Keywords
    Peripheral nerve block

    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
    Ropivacaine 0.75%
    Arm Type
    Active Comparator
    Arm Description
    The investigators administer 5 milliliters of Ropivacaine 0.75% in the inter scalene space
    Arm Title
    Levobupivacaine 0.5%
    Arm Type
    Active Comparator
    Arm Description
    The investigators administer 5ml of Levobupivacaine 0.5% in the inter scalene space
    Arm Title
    Levobupivacaine 0.5% + epinephrin
    Arm Type
    Active Comparator
    Arm Description
    The investigators administer 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in the inter scalene space
    Intervention Type
    Drug
    Intervention Name(s)
    Ropivacaine 0.75%
    Other Intervention Name(s)
    Naropin
    Intervention Description
    The investigators adminster 5ml of Ropivacaine 0.75% in an ultrasound-guided inter scalene nerve block
    Intervention Type
    Drug
    Intervention Name(s)
    Levobupivacaine 0.5%
    Other Intervention Name(s)
    Chirocaine
    Intervention Description
    The investigators adminster 5ml of Levobupivacaine 0.5% in an ultrasound-guided inter scalene nerve block
    Intervention Type
    Drug
    Intervention Name(s)
    Levobupivacaine 0.5% + epinephrin 1/200000
    Other Intervention Name(s)
    Chirocaine
    Intervention Description
    The investigators adminster 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in an ultrasound-guided inter scalene nerve block
    Primary Outcome Measure Information:
    Title
    Length of nerve block measured in longitudinally recorded significant changes in sensory thresholds using quantitative sensory testing
    Description
    Length of difference in cold and heat pain and sensation measured with quantitative sensory testing
    Time Frame
    24 hours after intervention
    Secondary Outcome Measure Information:
    Title
    Need for rescue drugs, as requested by the patient after surgery
    Time Frame
    24 hours after intervention
    Title
    Motor activity block, longitudinally recorded inability to move the blocked limb
    Time Frame
    24 hours after intervention
    Title
    Intensity of nerve block, recorded as maximal changes in sensory thresholds using quantitative sensory testing
    Description
    The difference in threshold of cold and heat pain and sensation measured with quantitative sensory testing
    Time Frame
    24 hours after intervention

    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: American Society of Anesthesia class I or II Scheduled for shoulder surgery Exclusion Criteria: Mental retardation Allergy for local anesthetics NSAID intolerance or contraindicated Diabetes mellitus Chronic use of pain killers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Luc Serieus, MD
    Organizational Affiliation
    University Hospital, Antwerp
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29725795
    Citation
    Sermeus LA, Schepens T, Hans GH, Morrison SG, Wouters K, Breebaart MB, Smitz CJ, Vercauteren MP. A low dose of three local anesthetic solutions for interscalene blockade tested by thermal quantitative sensory testing: a randomized controlled trial. J Clin Monit Comput. 2019 Apr;33(2):307-316. doi: 10.1007/s10877-018-0150-3. Epub 2018 May 3.
    Results Reference
    derived

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    Comparison of the Analgesic Effect of Different Local Anesthetics in Interscalene Nerve Block for Shoulder Surgery

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