Impact Evaluation of Perioperative Locoregional Analgesia on Persistent Postoperative Pain in Children After Orthopedic Surgery for Traumatology : a Prospective, Single Center, Randomised Controlled Study.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Persistent Postoperative Pain
研究概览
简要总结
Persistent postoperative pain is a substantial pain (scores 4-10 using a 0-10 numeric scale) that develops 3 months after surgery.
Persistent postoperative pain can be a problem even in ambulatory surgery. Loco-regional analgesia could prevent the occurrence of this pathology but contradictory results are found in ancient studies.
This study is the first randomized controlled study in children about loco-regional analgesia and persistent postoperative pain in traumatologic orthopedic surgery.
One interventional arm will receive a locoregional analgesia after general anesthesia and before incision. The other arm will only receive systemic analgesia during general anesthesia.
The incidence of persistent postoperative pain at 3, 6 and 12 months will be compared in these two groups.
The goal is to show the decrease of the incidence of the persistent postoperative pain in the group "locoregional analgesia".
详细描述
Patients between 5 years old and 15 years, 3 months old operated for a traumatologic orthopedic surgery in CHU Nantes will be included in this study.
Patients between 5 years old and 15 years, 3 months old operated for a traumatologic orthopedic surgery in CHU Nantes will be included in this study.
They will be randomized in two groups. General anesthesia will be administered in both groups.
One arm will receive a locoregional analgesia guiding by echography before incision with a local anesthetic (Carbocaïne) and a systemic analgesia if necessary. One arm will only receive a systemic analgesia.
The drugs used for general anesthesia and systemic analgesia will be standardized in the two groups.
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
- None
入排标准
- 年龄范围
- 5 Years 至 183 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 5 years old and 15 years and 3 months
- •Traumatologic orthopedic surgery in CHU Nantes
- •Conscious patient (Glasgow score =15)
- •Patients able to give a verbal assessment of their pain
- •No contraindication to Locoregional Analgesia
- •Patient member of the social security system
- •Oral consent of the patient
- •Signed consent of one of the two holders of parental authority
排除标准
- •Refusal to participate of the patient or one of the two holders of parental authority
- •Neurologic deficit of the operated limb before intervention
- •Ischemia of the operated limb before intervention
- •Polytraumatized patient
- •Allergia to Carbocaïne
- •Atrioventricular conduction disorders
- •Patient included in an other study about analgesia
- •Anticoagulant treatment
- •Uncontrolled epilepsy despite treatment
- •Porphyria
研究组 & 干预措施
Loco-Regional Analgesia
Patients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary
- Carbocaine
干预措施: Carbocaine (Drug)
Loco-Regional Analgesia
Patients will receive Loco-Regional Analgesia during General Anesthesia, and systemic analgesia if necessary
- Carbocaine
干预措施: Profofol and/or Suxaméthonium and/or Sévoflurane (Drug)
Systemic Analgesia Only
Patients will just receive General Anesthesia and systemic analgesia.
_ Profofol and/or Suxaméthonium and/or Sévoflurane
干预措施: Profofol and/or Suxaméthonium and/or Sévoflurane (Drug)
结局指标
主要结局
Persistent Postoperative Pain
时间窗: 3 months after surgery
Numerical Scale of pain superior to 3 (0 to 10). 0 : no pain - better outcome 10 : max of pain - worse outcome
次要结局
- Persistent postoperative pain at 12 months.(12 months after surgery.)
- Intravenous Morphine dose received in Post Interventional Care Unit(in Post Interventional Care Unit after the surgery-)
- Opioïd dose received - in Post Interventional Care Unit(in Post Interventional Care Unit after the surgery-)
- Screening of neuropathic pain if persistent postoperative pain - 3 months(3 months after surgery.)
- Screening of neuropathic pain if persistent postoperative pain - 12 months(12 months after surgery.)
- 1st EN score in immediate post-operative ICU before morphine titration(in Post Interventional Care Unit after the surgery)
- Persistent postoperative pain at 6 months.(6 months after surgery.)
- Postoperative nausea and vomiting(In Post Interventional Care Unit - after the surgery-)
- Time in Post Interventional Care Unit(In Post Interventional Care Unit - after the surgery -)
- Opioïd dose received - Per-operative(Per-operative)
- Opioïd dose received(during the first post-operative 24 hours in the surgery department)
- Screening of neuropathic pain if persistent postoperative pain - 6 months(6 months after surgery.)