Role of Femoral Nerve Block on Prevention of Postoperativ... | NCT02411097

Studies
Role of Femoral Nerve Block on Prevention of Postoperative Deep Venous Thromboembolism

NCT02411097

Sponsor

General Hospital of Ningxia Medical University

Status

Unknown status

Last Update Posted

Apr 8, 2015Estimated

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Gonarthrosis

Interventions

femoral nerve block

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

Mar 2015

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

Sep 2014

Primary Completion Date

Sep 2015Estimated

Completion Date

Oct 2015Estimated

First Submitted Date

Mar 20, 2015

First Submission Date that Met QC Criteria

Apr 2, 2015

First Posted Date

Apr 8, 2015Estimated

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

Apr 2, 2015

Last Update Posted Date

Apr 8, 2015Estimated

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 investigate whether preemptive analgesic of femoral nerve block could prevent deep venous thromboembolism due to inhibiting the excessive release of neutrophil elastase and inflammatory cytokines.

Detailed Description

Femoral nerve block is an effective analgesic mode in patients after total knee arthroplasty. In recent studies, there has been shown that a large amount of neutrophil elastase release from neutrophils could induce the development of deep venous thromboembolism and femoral nerve block may reduce the incidence of the development of deep venous thromboembolism. In addition, inflammatory cytokines including interleukin-1(IL-1), IL-6, IL-8 and tumor necrosis factor(TNF) were associated with deep venous thromboembolism. Thus, the investigators hypothesised that preemptive analgesic of femoral nerve block could prevent deep venous thromboembolism due to inhibiting the excessive release of neutrophil elastase and inflammatory cytokines.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
femoral nerve block	Experimental	femoral nerve block will be administered before or after the surgery	Procedure: femoral nerve block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
femoral nerve block	Procedure	use the nerve stimulator,the femoral nerve block will be administered before or after the surgery	femoral nerve block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum concentration of inflammatory cytokine		change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation

Secondary Outcomes

Measure	Description	Time Frame
Concentration of related inflammatory factors of deep venous thromboembolism	inflammatory factors include IL-1, IL-6, IL-8 and TNF，detecting the concentrations by enzyme-linked immunosorbent assay (ELISA).	change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation

Other Outcomes

Measure	Description	Time Frame
Diagnosis of deep venous thromboembolism by ultrasonography	result of diagnosis is yes or no	2day and 7day after operation

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients scheduled for total knee arthroplasty under general anesthesia

Exclusion Criteria:

ASA physical status Ⅳ-Ⅴ,
psychiatric illness,
chronic opioid consumption,
patient refusal,
coagulopathy,
peripheral neurological injury,
local anesthesia drug allergy,
preoperative existing deep venous thromboembolism.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xinli Ni	Contact	+086 951-6743252		xinlini6@yahoo.com

Overall Officials

Name	Affiliation	Role
Xu Wang	Gereral Hospital of Ningxia Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
General Hospital of Ningxia Medical University	Recruiting	Yinchuan	Ningxia	750004	China

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

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Browse Branches

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