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

April 2, 2015 updated by: General Hospital of Ningxia Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

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
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
        • Contact:

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: femoral nerve block
femoral nerve block will be administered before or after the surgery
Procedure: femoral nerve block
use the nerve stimulator,the femoral nerve block will be administered before or after the surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concentration of related inflammatory factors of deep venous thromboembolism
Time Frame: change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation
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 Outcome Measures

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

Collaborators and Investigators

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

Sponsor

General Hospital of Ningxia Medical University

Investigators

  • Principal Investigator: Xu Wang, Gereral Hospital of Ningxia Medical University

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

September 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

March 20, 2015

First Submitted That Met QC Criteria

April 2, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJGG2014

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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