search
Back to results

The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine

Primary Purpose

Fascicular Block, Motor Activity, Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
high Clonidine concentration
low clonidine concentration
Lidocaine
Lidocaine 40 ml
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fascicular Block focused on measuring brachial plexus, lidocaine, alfa 2 adrenergic receptor clonidine, orthopedic procedure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • both genders,
  • over 18 years old,
  • American Society of Anesthesiologists (ASA) 1 to 3

Exclusion Criteria:

  • patients with chronic use of analgesics and non-steroidal anti-inflammatories drugs,
  • pregnant,
  • with infection at the puncture site,
  • coagulopathies or intolerance to drugs used in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    low clonidine concentration

    lidocaine 20 ml 1,5%

    high clonidine concentration

    40 ml lidocaine 1,5%

    Arm Description

    clonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus

    lidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery

    clonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus

    40 ml of lidocaine 1,5% without clonidine for upper brachial plexus

    Outcomes

    Primary Outcome Measures

    sensorial and motor block duration
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block duration

    Secondary Outcome Measures

    adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
    analyse the adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
    postoperative analgesia duration
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms of postoperative analgesia duration
    sensorial and motor block onset time
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block onset time
    postoperative pain intensity
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms postoperative pain intensity

    Full Information

    First Posted
    June 9, 2012
    Last Updated
    June 14, 2012
    Sponsor
    Universidade Federal do Rio de Janeiro
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01620112
    Brief Title
    The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
    Official Title
    The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine for Upper Limb Surgery: a Prospective Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    July 2011 (Actual)
    Study Completion Date
    July 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal do Rio de Janeiro

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether different clonidine concentration on axillary brachial plexus block with 1,5% lidocaine for upper limb surgery may influence the sensory and motor block onset time and duration, postoperative analgesia duration, postoperative pain intensity
    Detailed Description
    Brachial plexus blocks are frequently used in surgical procedures involving the upper limb because they facilitate surgical anaesthesia, muscle relaxation and post-operative analgesics. Various drugs are used to supplement local anaesthetics during brachial plexus block. Many studies in the literature show that clonidine, which is an alpha-2 agonist, prolongs the length of anesthesia and post-operative analgesia.4,5 However, clonidine's side effects-such as hypotension, bradycardia and sedation can limit its use. There are no studies comparing different clonidine concentrations on the axillary brachial block, so the hypothesis of the present study was that different clonidine concentrations and LA volumes may influence the anaesthesia and analgesia quality on this type of regional block.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fascicular Block, Motor Activity, Pain, Postoperative, Latency Period
    Keywords
    brachial plexus, lidocaine, alfa 2 adrenergic receptor clonidine, orthopedic procedure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    low clonidine concentration
    Arm Type
    Active Comparator
    Arm Description
    clonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus
    Arm Title
    lidocaine 20 ml 1,5%
    Arm Type
    Active Comparator
    Arm Description
    lidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery
    Arm Title
    high clonidine concentration
    Arm Type
    Active Comparator
    Arm Description
    clonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus
    Arm Title
    40 ml lidocaine 1,5%
    Arm Type
    Active Comparator
    Arm Description
    40 ml of lidocaine 1,5% without clonidine for upper brachial plexus
    Intervention Type
    Drug
    Intervention Name(s)
    high Clonidine concentration
    Intervention Description
    Clonidine 1 ml - 150 mcg on 20 ml de lidocaine 1,5% on axillary brachial plexus block for upper limb surgery
    Intervention Type
    Drug
    Intervention Name(s)
    low clonidine concentration
    Intervention Description
    Clonidine 1 ml - 150 mcg on 40 ml of lidocaine 1,5% - single injection on axillary brachial plexus block for upper limb
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Intervention Description
    Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine 40 ml
    Intervention Description
    Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery
    Primary Outcome Measure Information:
    Title
    sensorial and motor block duration
    Description
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block duration
    Time Frame
    24 hours after surgery
    Secondary Outcome Measure Information:
    Title
    adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
    Description
    analyse the adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
    Time Frame
    24 hours after surgery
    Title
    postoperative analgesia duration
    Description
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms of postoperative analgesia duration
    Time Frame
    24 hours
    Title
    sensorial and motor block onset time
    Description
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block onset time
    Time Frame
    24 hours
    Title
    postoperative pain intensity
    Description
    to compare two concentrations of clonidine on different volumes of lidocaine, in terms postoperative pain intensity
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: both genders, over 18 years old, American Society of Anesthesiologists (ASA) 1 to 3 Exclusion Criteria: patients with chronic use of analgesics and non-steroidal anti-inflammatories drugs, pregnant, with infection at the puncture site, coagulopathies or intolerance to drugs used in the study

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine

    We'll reach out to this number within 24 hrs