The Effects of Different Clonidine Concentrations on Axillary Brachial Plexus Block With 1,5% Lidocaine
1 other identifier
interventional
60
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 9, 2012
CompletedFirst Posted
Study publicly available on registry
June 15, 2012
CompletedJune 15, 2012
June 1, 2012
2.4 years
June 9, 2012
June 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sensorial and motor block duration
to compare two concentrations of clonidine on different volumes of lidocaine, in terms of sensorial and motor block duration
24 hours after surgery
Secondary Outcomes (4)
adverse effects of additive clonidine on axillary brachial plexus block in upper limb surgery
24 hours after surgery
postoperative analgesia duration
24 hours
sensorial and motor block onset time
24 hours
postoperative pain intensity
24 hours
Study Arms (4)
low clonidine concentration
ACTIVE COMPARATORclonidine concentration 1 ml on 40 ml of lidocaine 1.5% for upper brachial plexus
lidocaine 20 ml 1,5%
ACTIVE COMPARATORlidocaine 20 ml 1,5% without clonidine for axillary brachial plexus block for upper limb surgery
high clonidine concentration
ACTIVE COMPARATORclonidine concentration 150 mcg on 20 ml of lidocaine 1,5% for upper brachial plexus
40 ml lidocaine 1,5%
ACTIVE COMPARATOR40 ml of lidocaine 1,5% without clonidine for upper brachial plexus
Interventions
Clonidine 1 ml - 150 mcg on 20 ml de lidocaine 1,5% on axillary brachial plexus block for upper limb surgery
Clonidine 1 ml - 150 mcg on 40 ml of lidocaine 1,5% - single injection on axillary brachial plexus block for upper limb
Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery
Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery
Eligibility Criteria
You may qualify if:
- both genders,
- over 18 years old,
- American Society of Anesthesiologists (ASA) 1 to 3
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assad AR
Study Record Dates
First Submitted
June 9, 2012
First Posted
June 15, 2012
Study Start
February 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
June 15, 2012
Record last verified: 2012-06