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Plasma Concentrations of Bupivacaine After Peri-articular Injection in Total Knee Arthroplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636869
First Posted: July 10, 2012
Last Update Posted: July 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Saowaphak Lapmahapaisan, Mahidol University
  Purpose
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.

Condition Intervention Phase
Serum Bupivacaine Level Periarticular Block Total Knee Arthroplasty Drug: Bupivacaine Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Plasma Concentrations of Bupivacaine After Spinal Anesthesia With Single Shot Femoral Nerve Block and Peri-articular Injection in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Saowaphak Lapmahapaisan, Mahidol University:

Primary Outcome Measures:
  • plasma concentration of bupivacaine after spinal anesthesia with single-shot femoral nerve block and periarticular block [ Time Frame: 2 hours ]

Secondary Outcome Measures:
  • bupivacaine toxicity [ Time Frame: 24 hr ]

Enrollment: 43
Study Start Date: July 2012
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bupicavaine Drug: Bupivacaine

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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patient's refusal
  • allergic to bupivacaine
  • body weight less than 50 kg
  • liver disease
  • heart disease
  • coagulopathy
  • Hct<35%
  • infection at both groin
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636869


Locations
Thailand
Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
  More Information

Responsible Party: Saowaphak Lapmahapaisan, instructor, Mahidol University
ClinicalTrials.gov Identifier: NCT01636869     History of Changes
Other Study ID Numbers: 010/2555
First Submitted: July 5, 2012
First Posted: July 10, 2012
Last Update Posted: July 28, 2014
Last Verified: July 2014

Keywords provided by Saowaphak Lapmahapaisan, Mahidol University:
bupivacaine level
periarticular block
total knee arthroplasty

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents