2% Lidocaine Plus 0.5% Bupivacaine Versus 0.5% Bupivacain... | NCT00993746

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

NCT00993746

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

May 17, 2010Estimated

Enrollment

90Estimated

Phase

Phase 4

Conditions

Infraclavicular Brachial Plexus Block

Interventions

Bupivacaine plus lidocaine
Bupivacaine 30 ml

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Sep 2010Estimated

Completion Date

Sep 2011Estimated

First Submitted Date

Sep 27, 2009

First Submission Date that Met QC Criteria

Oct 9, 2009

First Posted Date

Oct 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 14, 2010

Last Update Posted Date

May 17, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bupivacaine plus lidocaine	Active Comparator	Group 1: bupivacaine 20 ml plus lidocaine 10 ml	Drug: Bupivacaine plus lidocaine
Bupivacaine alone	Experimental	Group 2: bupivacaine 30 ml	Drug: Bupivacaine 30 ml

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine plus lidocaine	Drug	Bupivacaine 20 ml plus lidocaine 10 ml	Bupivacaine plus lidocaine

Measure	Description	Time Frame
onset of sensory block		24 hour

Measure	Description	Time Frame
onset of motor block		24 hour

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Orawan Pongraweewan, MD,FRCA	Contact	6681-4317599		pongraweewan@yahoo.com

Overall Officials

Name	Affiliation	Role
Orawan Pongrawewan, MD	Siriraj Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of anesthesiology Siriraj Hospital Mahidol University	Recruiting	Bangkok		10700	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D001164	Arteriovenous Fistula

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
D008012	Lidocaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided