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

Primary Purpose

Gonarthrosis

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

femoral nerve block

About this trial

This is an interventional prevention trial for Gonarthrosis focused on measuring Deep venous thromboembolism, Femoral nerve block, Total knee arthroplasty

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

General Hospital of Ningxia Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

femoral nerve block

Arm Description

femoral nerve block will be administered before or after the surgery

Outcomes

Primary Outcome Measures

Serum concentration of inflammatory cytokine

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT02411097

First Posted

March 20, 2015

Last Updated

April 2, 2015

Sponsor

General Hospital of Ningxia Medical University

1. Study Identification

Unique Protocol Identification Number

NCT02411097

Brief Title

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

Official Title

Prevention of Deep Venous Thromboembolism: Effect of Preemptive Analgesic of Femoral Nerve Block in Patients Undergoing Total Knee Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

General Hospital of Ningxia Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gonarthrosis

Keywords

Deep venous thromboembolism, Femoral nerve block, Total knee arthroplasty

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

femoral nerve block

Arm Type

Experimental

Arm Description

femoral nerve block will be administered before or after the surgery

Intervention Type

Procedure

Intervention Name(s)

femoral nerve block

Intervention Description

use the nerve stimulator,the femoral nerve block will be administered before or after the surgery

Primary Outcome Measure Information:

Title

Serum concentration of inflammatory cytokine

Time Frame

change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation

Secondary Outcome Measure Information:

Title

Concentration of related inflammatory factors of deep venous thromboembolism

Description

inflammatory factors include IL-1, IL-6, IL-8 and TNF，detecting the concentrations by enzyme-linked immunosorbent assay (ELISA).

Time Frame

change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation

Other Pre-specified Outcome Measures:

Title

Diagnosis of deep venous thromboembolism by ultrasonography

Description

result of diagnosis is yes or no

Time Frame

2day and 7day after operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xinli Ni

Phone

+086 951-6743252

xinlini6@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xu Wang

Organizational Affiliation

Gereral Hospital of Ningxia Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Hospital of Ningxia Medical University

City

Yinchuan

State/Province

Ningxia

ZIP/Postal Code

750004

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinli Ni

Phone

13909586966

xinlini6@yahoo.com

First Name & Middle Initial & Last Name & Degree

Yi Chen

Phone

18295184600

czzyxgp@163.com

12. IPD Sharing Statement

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

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