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2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacaine in Brachial Block for Creation of Arteriovenous (AV) Fistula

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Mahidol University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00993746
First Posted: October 12, 2009
Last Update Posted: May 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
  Purpose
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?

Condition Intervention Phase
Infraclavicular Brachial Plexus Block Drug: Bupivacaine plus lidocaine Drug: Bupivacaine 30 ml Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • onset of sensory block [ Time Frame: 24 hour ]

Secondary Outcome Measures:
  • onset of motor block [ Time Frame: 24 hour ]

Estimated Enrollment: 90
Study Start Date: October 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bupivacaine plus lidocaine
Group 1: bupivacaine 20 ml plus lidocaine 10 ml
Drug: Bupivacaine plus lidocaine
Bupivacaine 20 ml plus lidocaine 10 ml
Other Name: Marcaine Xylocaine
Experimental: Bupivacaine alone
Group 2: bupivacaine 30 ml
Drug: Bupivacaine 30 ml
Bupivacaine 30 ml for ultrasound guided infraclavicular brachial plexus block
Other Name: lidocaine, marcaine

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993746


Contacts
Contact: Orawan Pongraweewan, MD,FRCA 6681-4317599 pongraweewan@yahoo.com

Locations
Thailand
Department of anesthesiology Siriraj Hospital Mahidol University Recruiting
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Orawan Pongrawewan, MD Siriraj Hospital
  More Information

Responsible Party: Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00993746     History of Changes
Other Study ID Numbers: si433/2009
First Submitted: September 27, 2009
First Posted: October 12, 2009
Last Update Posted: May 17, 2010
Last Verified: October 2009

Keywords provided by Mahidol University:
Ultrasound guided infraclavicular brachial plexus block
Bupivacaine
Bupivacaine plus lidocaine
End stage renal disease
Arteriovenous fistula

Additional relevant MeSH terms:
Fistula
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Lidocaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action