Early and Late Effects of Nefopam in Multimodal Analgesia After Total Hip Arthroplasty (NEFARTHRO): a Multicentric Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 546
- 试验地点
- 2
- 主要终点
- Cumulative morphine consumption from the end of surgery (Day 0 - Hour 0) to the first 24 hours after surgery, expressed in mg of intravenous morphine (including titration in the Post-Anesthesia care Unit PACU).
研究概览
简要总结
NEFARTHRO is a multicentric randomized controlled trial comparing the effects of discontinuous infusions of nefopam (bolus) versus continuous infusion of intravenous nefopam (via an infusion pump) versus placebo on the opioid-request during the first 24 hours following a Total Hip arthroplasty, as part of multimodal analgesia including at least paracetamol and a Non-Steroidal Anti-Inflammatory Drug (NSAID).
The primary endpoint is cumulative morphine consumption for the first postoperative 24 hours, expressed in mg of iv equivalent morphine, including titration in the Post Anesthesia Care Unit (PACU).
Patients will be followed during 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patient, investigator and outcome assessor will be blind., A nurse anesthetist who will not be involved in the follow up of the patient will receive the kit and prepare the syringes.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged ≥ 18 years, fluent in French.
- •Planned primary or secondary total hip replacement, regardless of surgical approach or type of prosthesis.
- •Receiving paracetamol and ketoprofen postoperatively.
- •Under general anesthesia or spinal anesthesia (without intrathecal morphine).
- •Participant affiliated to a social security scheme
- •Participant's free, informed and written consent
排除标准
- •Septic or carcinological surgery
- •Allergy to paracetamol, nefopam or NSAIDs
- •Angle-closure glaucoma
- •Prostate adenoma
- •history of convulsion
- •Nocturnal pollakiuria in men with more than two risings per night
- •Severe hepatic (Child C) or cardiac insufficiency (LVEF < 30%)
- •Renal insufficiency with creatinine clearance < 50 mL/ min according to Cockroft's formula
- •Active peptic ulcer or history of digestive bleeding or peptic perforation
- •Patients with opioid treatment for chronic pain other than coxarthrosis (fentanyl, oral morphine > 50mg/d or equivalent)
- •Protected patient: safeguard of justice, guardianship or curatorship
- •Incomprehension or inability to use a numerical rating scale or to self-assess/manage pain
- •Pregnancy or breast-feeding
研究组 & 干预措施
Nefopam "bolus" group
干预措施: Nefopam (Drug)
Nefopam "CIVI" group
干预措施: Nefopam (Drug)
Control group
干预措施: NaCl 0.9% (Drug)
结局指标
主要结局
Cumulative morphine consumption from the end of surgery (Day 0 - Hour 0) to the first 24 hours after surgery, expressed in mg of intravenous morphine (including titration in the Post-Anesthesia care Unit PACU).
时间窗: between Day 0 - Hour 0 and Hour 24 post surgery
次要结局
- Length of stay.(At Day 0 - Hour 0 up to Day 5 or at discharge)
- Time to abandon canes/crutches.(At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6)
- Chronic pain at 6 months (at rest and walking) using a standardized phone questionnaire.(At Month 6)
- Maximum self-assessed pain using the Numeric Rating Scale ranging from 0 (no pain) to 10 (maximum pain) at rest in the PACU, at rest and on walking between PACU discharge and Hour 24, at Hour 24, and at hospital discharge.(at PACU, between PACU discharge and Hour 24, at Hour 24 and at Day 5 of hospital discharge)
- Time to return to walking.(At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6)
- Time to climb stairs.(At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6)
- Financial impact of spreading the recommended strategy following the results of the clinical study, estimated per year and over a 5-year period, from the point of view of the French Health Insurance and from the hospital perspective.(5 years)
- Time to leave room.(At Hour 24, at Day 5 or at discharge, whichever came first and at Month 6)
- Incidence of patients with morphine side effects(at Hour 24 and up to day 5)
- Opioid analgesic consumption between days 1 and 5 or at hospital discharge(at Hour 24 and up to day 5)
- Neuropathic pain score (DN2)The DN2 is a simplified version of the DN4, with 7 items: burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching (scored 0=absent, 1=present).(At Hour 24 and Month 6)
- Incidence of all serious AEs during patient follow-up and non-serious AEs.(at Hour 24 and up to day 5)