Analgesic Efficacy of Echoguided Maxillary and Mandibular Nerve Blocks in Planned Maxillomandibular Osteotomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The opioid consumption (in Morphine Milligram Equivalents) after the first 24 hours post-surgery.
研究概览
简要总结
Maxillo-mandibular osteotomy is a painful surgery which requires mostly opioids use. Recent studies on maxillary and mandibular nerve blocks have suggested benefit in maxillo-facial surgery but have been poorly investigated in orthognathic surgery. This study is designed to evaluate analgesic effectiveness, through opioids consumption, of a bilateral double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.
详细描述
Maxillo-mandibular osteotomy is a frequent but painful procedure in maxillo-facial surgery. It mostly requires opioids use which lead to well known side effects. Regional anesthesia has strongly modified post-surgical rehabilitation of many procedures. Maxillary nerve block has proved its efficiency on opioid consumption reduction in pediatric cleft palet surgery but has been rarely evaluated in orthognathic surgery. Mandibular nerve block has never been investigated in maxillo-mandibular osteotomy as well as benefit of bilateral ultra-sound guided technique to perform these nerve blocks. Consequently, this trial is designed to evaluate analgesic effectiveness of a double ultra-sound guided nerve blocks (maxillar and mandibular nerve) in maxillo-mandibular osteotomy.
This monocentric, single-blinded, randomized controled trial is designed with 2 groups of 25 patients receiving either bilateral double ultra-sound guided nerve block (maxillary and mandibular) with ROPIVACAINE 4.75mg/mL either local infiltration of LIDOCAINE 1% at incision sites by surgeon after general anesthesia induction during maxillo-mandibular osteotomy. Per et post-surgery anesthesic protocol and analgesia are standardized for both group. The main outcome corresponds to opioid consumption in MME of the first 24h after surgery. Follow-up occurs at 24h and 48h after end of surgery to assess analgesia, pain and opioid consumption.
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
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from 15 to 45 years old,
- •Scheduled for maxillary-mandibular osteotomy,
- •Registered in French social insurance register,
- •With informed consent disclosure.
排除标准
- •American Society of Anesthesiologists (ASA) classification ≥ 3
- •Innate or acquired hemostasis pathology,
- •Peripheric neuropathy,
- •Drug intake for chronic pain,
- •Infection/scar at needle insertion site,
- •Associated rhinoplasty surgery,
- •Allergy to local anesthetics,
- •Pregnant woman or potentially,
- •Breastfeeding woman,
- •Already registered in other clinical trial,
- •Adults under legal protection of incapable adult,
- •Cognitive disease impairing using of evaluation tools performed in protocol,
- •All contraindication of anesthetics drugs used in protocol.
结局指标
主要结局
The opioid consumption (in Morphine Milligram Equivalents) after the first 24 hours post-surgery.
时间窗: 24 hours post-surgery
The opioid consumption (in Morphine Milligram Equivalents ) after the first 24hours post-surgery.
次要结局
- Maximal pain (Numerical Rating Scale) in recovery room, at 24h after surgery.(24 hours after surgery)
- Maximal pain (Numerical Rating Scale) in recovery room, at 48 hours after surgery.(48 hours after surgery)
- Evaluation of preoperative anxiety and fear using Amsterdam Preoperative Anxiety and Information Scale on post-surgical pain(pré-anesthesic visit (day -1 or day 0))
- Opioid consumption in Morphine Milligram Equivalents after the first 48 hours post-surgery.(48 hours post-surgery)
- Incidence of opioid-Emergent Adverse Events [Safety and Tolerability](3 days)
- Evaluation of patient satisfaction about medical care(3 days (maximum))
- Incidence of regional anesthesia-Emergent Adverse Event [Safety and Tolerability](3 days)