Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.

赞助:

合作者:

信息的提供 (责任方):

J P Lecoq，University Hospital of Liege

追踪信息

首次提交日期 ^ICMJE

September 28, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

April 16, 2018

预计主要完成日期

October 2018 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Frequency of unplanned analgesia interventions.[ Time Frame: up to 72 hours after surgery ]

Composite criteria including the frequency of unplanned analgesia interventions administered by the patient, or paramedical and medical staff, and by extenstion the total amount of opioids (in milligrams equivalent morphine) and local anesthetics (in milligrams) received in post-operative period.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Pain difference[ Time Frame: up to 72 hours after surgery ]
Pain difference accessed by Numeric Pain Rating Scale (0-10), twice a day, at rest and on movement.
Motor block frequency[ Time Frame: up to 72 hours after surgery ]
Accessed by physiotherapist twice a day, by testing the Quadriceps muscle.
Mobilization quality during physiotherapy sessions.[ Time Frame: up to 72 hours after surgery ]
accessed by physiotherapist, ability to walk with or without help, take stairs, and flex and extend knee (comparatively to the opposite knee).
local anesthesia technique related complications[ Time Frame: until catheter removal 48 hours after surgery ]
rate of complications including: hematoma, infection, catheter dislodgement or breakage, allergic events.

描述性信息

简略标题 ^ICMJE

Local Anesthetic Automated Intermittent Administration vs. Continuous Infusion Via Femoral Nerve Block.

正式标题 ^ICMJE

Continuous Infusion vs. Programmed Intermittent Bolus of Ropivacaine Through Peri-neural Femoral Nerve Catheter After Total Knee Arthroplasty: Impact on Analgesia Quality and Motor Block Frequency.

简要概况

This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty.

详细说明

This study evaluates the impact of local anesthetic administration regiment through peri-neural femoral nerve catheter on pain and motor block frequency, after total knee arthroplasty. One group of patients will receive automated intermittent bolus, while the others will get a continuous infusion. In both cases, patients will be able to administer supplementary auto-bolus if required.

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)
programmed intermittent bolus 5ml each one hour.
Drug: Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)
continuous infusion 6ml/h

研究工具

Active Comparator: Continous infusion ropivacaine
Continuous infusion via peri-neural femoral nerve catheter of Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode) at rate of 6ml/h + patient controlled bolus of 3ml ...
Experimental: PIB ropivacaine
Programmed intermittent bolus of Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode) : 6ml each 60min + patient controlled bolus 3ml ...

招募信息

招募状态 ^ICMJE

Recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

December 2018

预计主要完成日期

October 2018 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - admitted for unilateral primary total knee arthroplasty. Exclusion Criteria: - ASA score > 3 - BMI > 40 - refusal of loco-regional technique. - psychiatric disease. - inability to understand/ use the Local anesthetic delivery pump. - local anesthetic allergy, - porphyry, - uncontrolled epilepsy, - severe cardiac arrhythmia.

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Belgium

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

J P Lecoq，University Hospital of Liege

研究赞助商 ^ICMJE

J P Lecoq

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Annis Orfi University Hospital of Liege

PRS 账户

University Hospital of Liege

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

请使用微信扫码报名