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

This study is currently recruiting participants.
Verified July 2012 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Saowaphak Lapmahapaisan, Mahidol University
ClinicalTrials.gov Identifier:
NCT01636869
First received: July 5, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  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: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bupivacaine toxicity [ Time Frame: 24 hr ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: July 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: July 2013 (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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636869

Contacts
Contact: Saowaphak Lapmahapaisan, M.D. 662-4197995 saowaphak.lap@mahidol.ac.th

Locations
Thailand
Faculty of Medicine, Siriraj Hospital, Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Saowaphak Lapmahapaisan, M.D.     662-419-7995     saowaphak.lap@mahidol.ac.th    
Principal Investigator: Saowaphak Lapmahapaisan, M.D.            
Sponsors and Collaborators
Mahidol University
  More Information

No publications provided

Responsible Party: Saowaphak Lapmahapaisan, instructor, Mahidol University
ClinicalTrials.gov Identifier: NCT01636869     History of Changes
Other Study ID Numbers: 010/2555
Study First Received: July 5, 2012
Last Updated: July 5, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by 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
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013