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Clinical Trials/NCT00980577
NCT00980577UnknownPhase 4

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

Peking University Third Hospital1 site in 1 country100 target enrollmentStarted: January 1, 2008Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Enrollment
100
Locations
1
Primary Endpoint
time and number of attempts to perform block, the efficacy of the block
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
30 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

NS

Active Comparator

stimulating catheter will be inserted using stimulator

Intervention: NUUS (Device)

Outcomes

Primary Outcomes

time and number of attempts to perform block, the efficacy of the block

Time Frame: during the block procedure

Secondary Outcomes

  • postoperative analgesic effect(pod 1-3)

Investigators

Sponsor Class
Other

Study Sites (1)

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