Effect of Combined Maxillary and Mandibular Nerve Block on Orthognathic Surgery Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total postoperative fentanyl rescue analgesic consumption
研究概览
简要总结
Mandibular fractures are among the most common (60-70%) maxillofacial fractures observed in emergency rooms. In the closed reduction (non-surgical), the bone fragments are realigned manually or by using traction devices. The open reduction surgery of mandibular fractures should first ensure the restoration of the occlusion of the mandible to prevent postoperative malocclusion, followed by stabilization by means of rigid fixations such as plates, screws, and rigid intermaxillary blocks in order to minimise any nonunion, malunion, or delayed union of the fracture segments. These surgical procedures are associated with moderate postoperative pain, being the first 24 hours the most intense pain period. Maxillary and mandibular nerve blocks are performed in patients with refractory trigeminal neuralgia. However, there have been few studies evaluating the analgesic effects of these blocks for maxillofacial surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Nerve block will be done by an anesthesiologist who will not be involved in data collection to ensure blindness.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) I/II patients,
- •within the age group of 21-60 years
- •scheduled for elective faciomaxillary surgery
排除标准
- •Pregnant or breast-feeding women
- •Patients with polytrauma
- •Patients necessitating postoperative ventilation
- •Oral or facial infection
- •Coagulopathy
- •Drug intake for chronic pain
- •Known allergy to the study drugs
- •Psychiatric disorder
研究组 & 干预措施
Maxillary and mandibular nerve block (MMNB) group
receive bilateral combined maxillary and mandibular nerve block. Three mL of 0.5% isobaric bupivacaine will be injected for each nerve block after negative aspiration of blood.
干预措施: Maxillary and mandibular nerve block (Procedure)
Control (C) group
not receive any nerve block
干预措施: Control (Other)
结局指标
主要结局
Total postoperative fentanyl rescue analgesic consumption
时间窗: first 24 hours postoperatively
microgram
次要结局
- Intraoperative heart rate (HR)(each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively)
- Intraoperative mean arterial pressure (MAP)(each 15 minutes Intraoperative plus 1hour postoperatively and 2hours postoperatively)
- Patients' satisfaction about their analgesia(24 hours postoperatively)
- 10-cm visual analogue scale (VAS)(at 0, 2, 4, 6, 8, 12, and 24 hours postoperatively)
- Postoperative analgesic duration(up to 24 hours (the time from ending of the nerve block till the first rescue morphine dose))
- Total postoperative diclofenac sodium consumption(24 hours postoperatively)
- The total Intraoperative supplementary fentanyl(during the intraoperative duration)
研究者
maha abou-zeid
Assistant Professor of Anesthesia and Surgical Intensive Care
Mansoura University