Stimulating Catheter With or Without Ultrasound Guidance

November 9, 2010 updated by: Peking University Third Hospital

Phase 2 Study of Stimulating Catheter for Continuous Femoral Nerve Block in Total Knee Replacement

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: NS
stimulating catheter will be inserted using stimulator
Device: NUUS
Sonosite Micro Maxx
Other Names:
  • stimulating catheter will be inserted under stimulator and ungrasoud guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time and number of attempts to perform block, the efficacy of the block
Time Frame: during the block procedure
during the block procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
postoperative analgesic effect
Time Frame: pod 1-3
pod 1-3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

November 1, 2009

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 18, 2009

First Posted (Estimate)

September 21, 2009

Study Record Updates

Last Update Posted (Estimate)

November 10, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

September 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • PUTH7275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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