Stimulating Catheter With or Without Ultrasound Guidance | NCT00980577

Studies
Stimulating Catheter With or Without Ultrasound Guidance

NCT00980577

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Nov 10, 2010Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Pain

Interventions

NUUS

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Nov 2009Estimated

Completion Date

Not provided

First Submitted Date

Sep 18, 2009

First Submission Date that Met QC Criteria

Sep 18, 2009

First Posted Date

Sep 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2010

Last Update Posted Date

Nov 10, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NS	Active Comparator	stimulating catheter will be inserted using stimulator	Device: NUUS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NUUS	Device	Sonosite Micro Maxx	NS	stimulating catheter will be inserted under stimulator and ungrasoud guidance

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
postoperative analgesic effect		pod 1-3

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Li, MD	Contact	86-10-82266688	8799	liminanesth@yahoo.com.cn
Xuedong Wang, MS	Contact	86-10-82266688	7260	wangxuedong1216@sina.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hosptial	Recruiting	Beijing		100191	China

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided