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

Infraclavicular Brachial Plexus Block Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00993746
• Other study ID #: si433/2009
• Status: Recruiting
• Phase: Phase 4
• First received: September 27, 2009
• Last updated: May 14, 2010
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: October 2009
• Source: Mahidol University
• Contact: Orawan Pongraweewan, MD,FRCA
• Phone: 6681-4317599
• Email: pongraweewan[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ???? BW < 35 kg

• History of allergy to local anesthetic drugs

• Pre-operative neurological deficit, Neuromuscular disorder ???? old CVA

• Psychiatric disorder

• Coagulation disorder

• Uncontrolled seizure

• Pregnant and lactating women

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Infraclavicular Brachial Plexus Block

Intervention

Drug:
• Bupivacaine plus lidocaine
Bupivacaine 20 ml plus lidocaine 10 ml
• Bupivacaine 30 ml
Bupivacaine 30 ml for ultrasound guided infraclavicular brachial plexus block

Locations

Country	Name	City	State
Thailand	Department of anesthesiology Siriraj Hospital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	onset of sensory block		24 hour	Yes
Secondary	onset of motor block		24 hour	Yes