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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
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00993746
First received: September 27, 2009
Last updated: May 14, 2010
Last verified: October 2009
History of Changes
  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
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov 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
Bupivacaine plus lidocaine
End stage renal disease
Arteriovenous fistula

Additional relevant MeSH terms:
Arteriovenous Fistula
Fistula
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Pathological Conditions, Anatomical
Bupivacaine
Lidocaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013