Opioid Free Anesthesia in Total Hip Arthroplasty. A Randomized, Controlled and Triple-blind Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery
研究概览
简要总结
Total hip arthroplasty (THA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.
Postoperative pain management in THA requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). But, the best anesthesia strategy to provide optimal postoperative analgesia in THA remains controversial. Opioid free anesthesia could limit the episodes of hyperalgesia as well as tolerance and addiction to opioids.
The hypothesis of this study is that an opioid free anesthesia using dexmedetomidine could improve analgesia after THA.
The main objective of this monocenter, prospective, randomized, triple-blind, controlled trial is to assess the interest of opioid free anesthesia using dexmedetomidine on morphine consumption after THA.
详细描述
In the pre-anaesthesia room, after the implementation of classical monitoring and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia & Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.
The patients will be then randomized in 2 groups:
Control group:
- Pre-operative normal saline infusion 100 ml over 30 minutes
- Injection of sufentanil 10 µg in normal saline 2 ml on induction of anesthesia
If needed after incision :
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older,
- •Undergoing outpatient primary total hip arthroplasty under general anesthesia with laryngeal mask,
- •Consent for participation,
- •Affiliation to a social security system
排除标准
- •Heart rate < 60 bpm
- •Chronic pain syndrome requiring preoperative morphine use (class 3)
- •Contraindication for: paracetamol, ketoprofen, nefopam, oxycodone, propofol, ketamine, cisatracurium, sufentanyl, ropivacaine.
- •Contraindication for dexmedetomidine: hypersensitivity to the active substance or to any of the excipients, advanced cardiac block (grade 2 or 3) unless paced ; uncontrolled hypotension ; acute cerebrovascular conditions
- •Contraindication to laryngeal mask : old insulin-dependent diabetes, gastro-oesophageal reflux, morbid obesity (defined by BMI > 35)
- •Pregnant or breastfeeding women
- •Women of child bearing potential without contraception (any contraceptive method used regularly and appropriately with a low failure rate: <1% per year),
- •A mental or linguistic inability to understand the study,
- •Patient under protection of the adults (guardianship, curators or safeguard of justice),
- •Patient included or planning to be included in another clinical trial relating to medications
研究组 & 干预措施
Control group
Sufentanil IV injection
干预措施: Sufentanil (Drug)
OFA group
Dexmedetomidine IV infusion
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery
时间窗: 24 hours
Postoperative cumulated dose of oxycodone in oral morphine equivalent (mg)
次要结局
- Postoperative pain at rest(24 hours)
- Analgesia in post-anesthesia care unit (PACU)(6 hours)
- Postoperative pain at walk(24 hours)
- Side effects associated with opioids(24 hours)
- Side effects associated with dexmedetomidine(24 hours)
- Outpatient care failure(24 hours)
- Length of stay in post-anesthesia care unit (PACU)(6 hours)
- Time to recover the ability to walk(12 hours)