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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 because the information has not been verified recently.
Verified October 2009 by Mahidol University.
Recruitment status was  Recruiting
Information provided by:
Mahidol University Identifier:
First received: September 27, 2009
Last updated: May 14, 2010
Last verified: October 2009
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • onset of motor block [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00993746

Contact: Orawan Pongraweewan, MD,FRCA 6681-4317599

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

Responsible Party: Faculty of Medicine Siriraj Hospital, Mahidol University Identifier: NCT00993746     History of Changes
Other Study ID Numbers: si433/2009 
Study First Received: September 27, 2009
Last Updated: May 14, 2010
Health Authority: Thailand: Ethical Committee

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

Additional relevant MeSH terms:
Arteriovenous Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Anesthetics, Local
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 processed this record on October 21, 2016