Observational Prospective Study of Opiate-free Anesthesia for Anterior Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cumulative morphine consumption
研究概览
简要总结
Opioid-free anesthesia (ATO) is a multimodal anaesthesia combining different analgesic and anesthetic modalities thus excluding opiates as an intraoperative. Recent studies have found a benefit from the ATO on postoperative rehabilitation and reduced length of hospitalization.
Periarticular infiltration with a local anesthetic is one of the measures proposed in OFA during the PTH.
PTH remains a painful procedure and the occurrence of morphinic-related side effects in sometimes elderly patients is often observed.
The main objective of this study is to assess the feasibility of ATO in anterior hip replacement under general anesthesia with the primary endpoint of morphine consumption measured 24 hours after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 and 85
- •ASA (American Society of Anesthesiology) I-III
- •Total Hip Prosthesis programmed anteriorly
- •Prior obtaining free and informed written consent .Affiliation or beneficiary of a social security scheme. Patients affiliated with or beneficiaries of a social security plan and not included in another trial.
排除标准
- •Pregnant women or breastfeeding Spinal anesthesia Patient on long-term opiate Body Mass Index (BMI) - 20 or 45kg/m2 Incomprehension of the ENS scale Unaccompanied cardiac conduction disorder, Adam-Stokes syndrome Preoperative Spontaneous Cardiac Frequency - 40 beats/min Left ventricle ejection fraction - 40% Unpaired sleep apnea syndrome (OSA) Adult incompetent, adults under guardianship or curatorial or deprived of liberty Allergy to one of the protocol products or their excipients: levobupivacaine, paracetamol, pregabalin, ketoprofen, dexmedetomidine Paracetamol-specific contraindication: hepatocellular deficiency Ketoprofen-specific contraindications: creatinine clearance - 60ml/min, ATCD of perforated peptic ulcer, heart failure, progressive hemorrhage, asthma associated with ketoprofen use Contraindications to nefopam: symptomatic prostate disorders, angle-closing glaucoma, epilepsy Participation in another clinical study
结局指标
主要结局
Cumulative morphine consumption
时间窗: 24 hours after the procedure
morphine equivalent \[mg\]
次要结局
未报告次要终点