NCT02411097

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 8, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 20, 2015

Last Update Submit

April 2, 2015

Conditions

Gonarthrosis

Keywords

Deep venous thromboembolismFemoral nerve blockTotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Serum concentration of inflammatory cytokine

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

Secondary Outcomes (1)

  • Concentration of related inflammatory factors of deep venous thromboembolism

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

Other Outcomes (1)

  • Diagnosis of deep venous thromboembolism by ultrasonography

    2day and 7day after operation

Study Arms (1)

femoral nerve block

EXPERIMENTAL

femoral nerve block will be administered before or after the surgery

Procedure: femoral nerve block

Interventions

femoral nerve blockPROCEDURE

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

femoral nerve block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients scheduled for total knee arthroplasty under general anesthesia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Xu Wang

    Gereral Hospital of Ningxia Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinli Ni

CONTACT

+086 951-6743252xinlini6@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2015

First Posted

April 8, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

April 8, 2015

Record last verified: 2015-03

Locations

CN(1)