GonarthrosisNCT02411097
Role of Femoral Nerve Block on Prevention of Postoperative Deep Venous Thromboembolism
A study testing femoral nerve block in people with Gonarthrosis, run by General Hospital of Ningxia Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- femoral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients scheduled for total knee arthroplasty under general anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Xinli Ni, 13909586966, xinlini6@yahoo.com
Yi Chen, 18295184600, czzyxgp@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gonarthrosis
- Being tested
- femoral nerve block
- Keywords
- Deep venous thromboembolism, Femoral nerve block, Total knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoral nerve blockProcedure or surgery
use the nerve stimulator,the femoral nerve block will be administered before or after the surgery
| Study group | Role | What they receive |
|---|---|---|
| femoral nerve block | Experimental | femoral nerve block will be administered before or after the surgery Receives: Procedure: femoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of inflammatory cytokine
Measured: 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
inflammatory factors include IL-1, IL-6, IL-8 and TNF，detecting the concentrations by enzyme-linked immunosorbent assay (ELISA).
Measured: change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xu Wang, Principal investigator, Gereral Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411097
- Sponsor's protocol ID
- CJGG2014
- Status last verified
- Mar 2015
- First submitted
- 20 Mar 2015
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Deep Venous Thromboembolism: Effect of Preemptive Analgesic of Femoral Nerve Block in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02411097
- Acronym / sponsor ID
- CJGG2014
- Conditions
- Gonarthrosis
- Keywords
- Deep venous thromboembolism, Femoral nerve block, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 8 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| femoral nerve block | Experimental | Procedure: femoral nerve blockfemoral nerve block will be administered before or after the surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients scheduled for total knee arthroplasty under general anesthesia
Key exclusion criteria (8 listed)
- ASA physical status Ⅳ-Ⅴ,
- psychiatric illness,
- chronic opioid consumption,
- patient refusal,
- coagulopathy,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| femoral nerve blockuse the nerve stimulator,the femoral nerve block will be administered before or after the surgery | Procedure or surgery | femoral nerve block |
Primary outcome
Serum concentration of inflammatory cytokine
Time frame: change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xu Wang principal investigator
Gereral Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing femoral nerve block in people with Gonarthrosis, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinli Ni (+086 951-6743252, xinlini6@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of inflammatory cytokine (time frame: change from baseline at 30min, 60min, 90min after using tourniquet and 12h, 24h,48h after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.