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Stimulating Catheter With or Without Ultrasound Guidance

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 September 2009 by Peking University Third Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00980577
First Posted: September 21, 2009
Last Update Posted: November 10, 2010
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:
Peking University Third Hospital
  Purpose
To study whether the combination of ultrasound guidance and stimulating catheter could reduce the time for needle and catheter insertion compared with using stimulating catheter alone. Secondary outcomes: analgesic effects after the surgery.

Condition Intervention Phase
Pain Device: NUUS Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Stimulating Catheter for Continuous Femoral Nerve Block in Total Knee Replacement

Further study details as provided by Peking University Third Hospital:

Primary Outcome Measures:
  • time and number of attempts to perform block, the efficacy of the block [ Time Frame: during the block procedure ]

Secondary Outcome Measures:
  • postoperative analgesic effect [ Time Frame: pod 1-3 ]

Estimated Enrollment: 100
Study Start Date: January 2008
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NS
stimulating catheter will be inserted using stimulator
Device: NUUS
Sonosite Micro Maxx
Other Name: stimulating catheter will be inserted under stimulator and ungrasoud guidance

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective primary total knee replacement surgery under neuraxial anesthesia ASA<=4
  • Able to give informed consent
  • Able to cooperate with sensory and motor testing of lower limb function

Exclusion Criteria:

  • coagulopathy
  • Allergy to local anaesthetic or postanalgesic rescue regimen
  • Signs, symptoms or laboratory evidence of local infection or systemic sepsis
  • No pre-existing neurological deficit (sensory or motor) affecting lower limb
  • Patients with lower limb amputations
  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): NCT00980577


Contacts
Contact: Min Li, MD 86-10-82266688 ext 8799 liminanesth@yahoo.com.cn
Contact: Xuedong Wang, MS 86-10-82266688 ext 7260 wangxuedong1216@sina.com

Locations
China
Peking University Third Hosptial Recruiting
Beijing, China, 100191
Sponsors and Collaborators
Peking University Third Hospital
  More Information

Responsible Party: Peng Ruicong, Peking University Health Science Center Review Board
ClinicalTrials.gov Identifier: NCT00980577     History of Changes
Other Study ID Numbers: PUTH7275
First Submitted: September 18, 2009
First Posted: September 21, 2009
Last Update Posted: November 10, 2010
Last Verified: September 2009