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

Not Applicable

• Conditions: Gonarthrosis
• Interventions: Procedure: femoral nerve block

• Registration Number: NCT02411097
• Lead Sponsor: General Hospital of Ningxia Medical University

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.

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-03
• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-04-02
• Last Update Submitted: 2015-04-02
• Study First Posted: 2015-04-08
• Last Update Posted: 2015-04-08
• Primary Completion: 2015-09
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
femoral nerve block	femoral nerve block	femoral nerve block will be administered before or after the surgery

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China