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

Gonarthrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02411097
• Other study ID #: CJGG2014
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2015
• Last updated: April 2, 2015
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: March 2015
• Source: General Hospital of Ningxia Medical University
• Contact: Xinli Ni
• Phone: +086 951-6743252
• Email: xinlini6[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• adult patients scheduled for total knee arthroplasty under general anesthesia

Exclusion Criteria:

• ASA physical status ?-?,

• psychiatric illness,

• chronic opioid consumption,

• patient refusal,

• coagulopathy,

• peripheral neurological injury,

• local anesthesia drug allergy,

• preoperative existing deep venous thromboembolism.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gonarthrosis
• Thromboembolism
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnosis of deep venous thromboembolism by ultrasonography	result of diagnosis is yes or no	2day and 7day after operation	Yes
Primary	Serum concentration of inflammatory cytokine		change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation	Yes
Secondary	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	Yes