NCT01636869

Brief Summary

Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot femoral nerve block and periarticular block, so we would like to know the plasma concentration of bupivacaine in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

July 5, 2012

Last Update Submit

July 25, 2014

Conditions

Serum Bupivacaine LevelPeriarticular BlockTotal Knee Arthroplasty

Keywords

bupivacaine levelperiarticular blocktotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • plasma concentration of bupivacaine after spinal anesthesia with single-shot femoral nerve block and periarticular block

    2 hours

Secondary Outcomes (1)

  • bupivacaine toxicity

    24 hr

Study Arms (1)

bupicavaine

EXPERIMENTAL
Drug: Bupivacaine

Interventions

BupivacaineDRUG

20 ml of 0.5% bupivacaine for single-shot femoral nerve block will be done at the beginning then another 20 ml of 0.5% bupivacaine for periarticular block will be performed at the end of operation. Blood sample will be drawn at 60 min after femoral nerve block and before periarticular block, 15, 30, 45, 60 min after periarticular block.

bupicavaine

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age of 30-70 yr
  • ASA I-II
  • patient undergo total knee arthroplasty under spinal block and single shot femoral nerve block and periarticular block

You may not qualify if:

  • patient's refusal
  • allergic to bupivacaine
  • body weight less than 50 kg
  • liver disease
  • heart disease
  • coagulopathy
  • Hct\<35%
  • infection at both groin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
instructor

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 10, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations

TH(1)