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Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by Okayama University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01198340
First Posted: September 10, 2010
Last Update Posted: July 22, 2011
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:
Okayama University
  Purpose
To evaluate an analgesic effect without basal administration of local anesthetics for patient-controlled femoral nerve block (with sciatic nerve block) after total knee arthroplasty.

Condition Intervention
Arthropathy of Knee Joint Procedure: PC-FNB with basal administration of local anesthetics Procedure: PC-FNB without basal local anesthetics

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of Optimal Dose of Local Anesthetics for Patient Controlled Continuous Femoral Nerve Block With Sciatic Nerve Block After Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Okayama University:

Primary Outcome Measures:
  • pain scores by use of numerous rating scale (NRS) [ Time Frame: 4 days after the surgery ]

Secondary Outcome Measures:
  • dose of local anesthetics [ Time Frame: 4 days after the surgery ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: With basal local anesthetics Procedure: PC-FNB with basal administration of local anesthetics
Administration of 0.2% ropivacaine for femoral nerve block with 3 ml/h of basal dose, 5ml bolus by the patient, 60 minutes of lock out time.
Other Name: PC-FNB with basal ropivacaine administration
Experimental: Without basal local anesthetics Procedure: PC-FNB without basal local anesthetics
Administration of 0.2% ropivacaine for femoral nerve block without basal dose, with 8 ml bolus by the patient, 60 minutes of lockout time.
Other Name: PC-FAB without basal ropivacaine administration

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients older than 20 yrs old scheduled for total knee arthroplasty

Exclusion Criteria:

  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): NCT01198340


Contacts
Contact: Hideki Taninishi, MD, PhD 81-86-235-7327 tanishi@ops.dti.ne.jp

Locations
Japan
Anesthesiology and Resuscitology, Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Contact: Hideki Taninishi, MD, PhD    81-86-235-7327    tanishi@ops.dti.ne.jp   
Principal Investigator: Hideki Taninishi, MD, PhD         
Sponsors and Collaborators
Okayama University
Investigators
Principal Investigator: Hideki Taninishi, MD, PhD Okayama University
  More Information

Responsible Party: Hideki Taninishi, Okayama University Medical School
ClinicalTrials.gov Identifier: NCT01198340     History of Changes
Other Study ID Numbers: TKAFEMORAL-2010
UMIN000004155 ( Registry Identifier: UMIN.JP )
First Submitted: September 8, 2010
First Posted: September 10, 2010
Last Update Posted: July 22, 2011
Last Verified: August 2010

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Anesthetics
Ropivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents