- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00993746
2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula
May 14, 2010 updated by: Mahidol University
Comparison of Onset of Action Between 2% Lidocaine Plus 0.5% Bupivacaine and 0.5% Bupivacaine in Brachial Plexus Anesthesia for Creation of Arteriovenous Fistula in ESRD Patient
Will the technique of adding lidocaine to bupivacaine fasten the onset of bupivacaine alone for infraclavicular brachial plexus block in end-stage renal disease (ESRD) patient?
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Orawan Pongraweewan, MD,FRCA
- Phone Number: 6681-4317599
- Email: pongraweewan@yahoo.com
Study Locations
-
-
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Bangkok, Thailand, 10700
- Recruiting
- Department of anesthesiology Siriraj Hospital Mahidol University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ESRD patient for AVF procedure
- age >17 year
- BMI 20-35 kg/m2
- communicable
Exclusion Criteria:
- BMI > 35 kg/m2 BMI < 20 kg/m2 หรือ BW < 35 kg
- History of allergy to local anesthetic drugs
- Pre-operative neurological deficit, Neuromuscular disorder หรือ old CVA
- Psychiatric disorder
- Coagulation disorder
- Uncontrolled seizure
- Pregnant and lactating women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bupivacaine plus lidocaine
Group 1: bupivacaine 20 ml plus lidocaine 10 ml
|
Bupivacaine 20 ml plus lidocaine 10 ml
Other Names:
|
Experimental: Bupivacaine alone
Group 2: bupivacaine 30 ml
|
Bupivacaine 30 ml for ultrasound guided infraclavicular brachial plexus block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
onset of sensory block
Time Frame: 24 hour
|
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
onset of motor block
Time Frame: 24 hour
|
24 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Orawan Pongrawewan, MD, Siriraj Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Anticipated)
September 1, 2010
Study Completion (Anticipated)
September 1, 2011
Study Registration Dates
First Submitted
September 27, 2009
First Submitted That Met QC Criteria
October 9, 2009
First Posted (Estimate)
October 12, 2009
Study Record Updates
Last Update Posted (Estimate)
May 17, 2010
Last Update Submitted That Met QC Criteria
May 14, 2010
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Congenital Abnormalities
- Pathological Conditions, Anatomical
- Cardiovascular Abnormalities
- Vascular Malformations
- Arteriovenous Malformations
- Vascular Fistula
- Fistula
- Arteriovenous Fistula
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Bupivacaine
Other Study ID Numbers
- si433/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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