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Stimulating Catheter With or Without Ultrasound Guidance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Peking University Third Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT00980577
First received: September 18, 2009
Last updated: November 9, 2010
Last verified: September 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • postoperative analgesic effect [ Time Frame: pod 1-3 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Peng Ruicong, Peking University Health Science Center Review Board
ClinicalTrials.gov Identifier: NCT00980577     History of Changes
Other Study ID Numbers: PUTH7275
Study First Received: September 18, 2009
Last Updated: November 9, 2010
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on November 20, 2014