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Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block

Primary Purpose

Analgesia, Pain, Acute, Peripheral Nerve Block

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
ropivacaine
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring upper extremity bone fracture

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age-18years and above
  • Both male and female patients
  • BMI->18
  • Elective Subacute upper extremity fractures

Exclusion Criteria:

  • Chronic pain patients (Pain persisting for more than 3-6months or past the normal healing time of any injury, influences every aspect of a person's quality of life.)
  • Patients with drug abuse history in the past 6 months
  • ESRD
  • Hepatic failure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    ropivacaine only

    ropivacaine with dexmedetomidine

    Arm Description

    0.5% ropivacaine

    25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine

    Outcomes

    Primary Outcome Measures

    Duration of Effect
    To determine the change in duration of analgesia by the time to first intake of analgesic medicine by adding 0.25mcg/kg of dexmedetomidine to 25 ml of 0.5%ropivacaine in Brachial plexus nerve block.

    Secondary Outcome Measures

    Potential Side Effects
    To look for the potential side effects of dexmedetomidine like bradycardia and hypotension in the intraoperative and immediate post-operative period.

    Full Information

    First Posted
    December 20, 2017
    Last Updated
    May 21, 2019
    Sponsor
    University of Florida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03385967
    Brief Title
    Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block
    Official Title
    A Randomized, Prospective, Double Blind Clinical Trial to Investigate the Increase in Duration of Analgesia With Addition of 0.25mcg/kg of Dexmedetomidine (DEX) to 25 ml of 0.5%Ropivacaine in Supraclavicular Brachial Plexus Block.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    PI is leaving the University of Florida
    Study Start Date
    April 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This is a prospective, randomized, double blind study of adding dexmedetomidine to ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales(0-10), Satisfaction scale by VAS scale(0-10) and time to first analgesic consumption. This study mainly aims to investigate whether addition of dexmedetomidine helps in increasing the duration of analgesia.
    Detailed Description
    In our institute ropivacaine is used for all the peripheral nerve blocks. This a prospective, randomized, double blind clinical trial study comparing the addition of dexmedetomidine vs ropivacaine alone in brachial plexus nerve block. After screening the patient with the inclusion criteria, an informed consent is obtained from the patient by one of the co-investigator. Adjuvants to local anesthetics are commonly added to prolong the duration of the peripheral nerve block. Sometimes patients have other added comorbidities along with high BMI with history of chronic pain where prolonging the duration of the peripheral nerve block would help with decreased narcotic consumption in the perioperative period with minimal side effects related to the local anesthetics(LA) as well as the adjuncts. Dexmedetomidine is proven to be better than Clonidine in a recent study. Also perineural dexmedetomidine is proven to be more efficacious compared to intravenous dosing. The investigators are evaluating whether adding dexmedetomidine to standard dose of Ropivacaine helps in prolonging the duration of the peripheral nerve block with minimal side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Analgesia, Pain, Acute, Peripheral Nerve Block
    Keywords
    upper extremity bone fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a prospective, randomized, double blind study of adding dexmedetomidine 0.25mcg/kg body weight to standard dose (25ml) of 0.5%ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales (0-10), Satisfaction scale by VAS scale (0-10) and time to first analgesic consumption.
    Masking
    ParticipantCare Provider
    Masking Description
    Double Blind
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ropivacaine only
    Arm Type
    Active Comparator
    Arm Description
    0.5% ropivacaine
    Arm Title
    ropivacaine with dexmedetomidine
    Arm Type
    Active Comparator
    Arm Description
    25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    precedex
    Intervention Description
    Addition of Dexmedetomidine in block .25mcg/kg of dexmedetomidine
    Intervention Type
    Drug
    Intervention Name(s)
    ropivacaine
    Other Intervention Name(s)
    naropin
    Intervention Description
    Standard of care 0.5%ropivacaine
    Primary Outcome Measure Information:
    Title
    Duration of Effect
    Description
    To determine the change in duration of analgesia by the time to first intake of analgesic medicine by adding 0.25mcg/kg of dexmedetomidine to 25 ml of 0.5%ropivacaine in Brachial plexus nerve block.
    Time Frame
    Immediate pre-op until 36hours post block
    Secondary Outcome Measure Information:
    Title
    Potential Side Effects
    Description
    To look for the potential side effects of dexmedetomidine like bradycardia and hypotension in the intraoperative and immediate post-operative period.
    Time Frame
    Immediate pre-op until 36hours post block

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age-18years and above Both male and female patients BMI->18 Elective Subacute upper extremity fractures Exclusion Criteria: Chronic pain patients (Pain persisting for more than 3-6months or past the normal healing time of any injury, influences every aspect of a person's quality of life.) Patients with drug abuse history in the past 6 months ESRD Hepatic failure
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alberto Ardon, MD
    Organizational Affiliation
    University of Florida College of Medicine Jacksonville
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block

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