NCT00993746

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 12, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 17, 2010

Status Verified

October 1, 2009

Enrollment Period

11 months

First QC Date

September 27, 2009

Last Update Submit

May 14, 2010

Conditions

Infraclavicular Brachial Plexus Block

Keywords

Ultrasound guided infraclavicular brachial plexus blockBupivacaineBupivacaine plus lidocaineEnd stage renal diseaseArteriovenous fistula

Outcome Measures

Primary Outcomes (1)

  • onset of sensory block

    24 hour

Secondary Outcomes (1)

  • onset of motor block

    24 hour

Study Arms (2)

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

Bupivacaine plus lidocaineDRUG

Bupivacaine 20 ml plus lidocaine 10 ml

Also known as: Marcaine Xylocaine
Bupivacaine plus lidocaine
Bupivacaine 30 mlDRUG

Bupivacaine 30 ml for ultrasound guided infraclavicular brachial plexus block

Also known as: lidocaine, marcaine
Bupivacaine alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ESRD patient for AVF procedure
  • age \>17 year
  • BMI 20-35 kg/m2
  • communicable

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of anesthesiology Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Kidney Failure, ChronicArteriovenous Fistula

Interventions

BupivacaineLidocaine

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular FistulaVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFistulaPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilides

Study Officials

  • Orawan Pongrawewan, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Orawan Pongraweewan, MD,FRCA

CONTACT

6681-4317599pongraweewan@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 27, 2009

First Posted

October 12, 2009

Study Start

October 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2011

Last Updated

May 17, 2010

Record last verified: 2009-10

Locations

TH(1)