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
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
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
NCT ID
NCT01620112
First Posted
June 9, 2012
Last Updated
June 14, 2012
Sponsor
Universidade Federal do Rio de Janeiro
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
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