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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Okayama University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Okayama University
ClinicalTrials.gov Identifier:
NCT01198340
First received: September 8, 2010
Last updated: July 20, 2011
Last verified: August 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • dose of local anesthetics [ Time Frame: 4 days after the surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hideki Taninishi, Okayama University Medical School
ClinicalTrials.gov Identifier: NCT01198340     History of Changes
Other Study ID Numbers: TKAFEMORAL-2010, UMIN000004155
Study First Received: September 8, 2010
Last Updated: July 20, 2011
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Anesthetics, Local
Ropivacaine
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 July 20, 2014