Intra-operative Trigeminal Nerve Block For Post-operative Pain Control After Orthognathic Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
This study will assess the efficacy and safety of levobupivacaine for postoperative pain control in patients received orthognathic surgery. In this split-mouth study, each side will be randomized to receive 1) 5ml 0.5% levobupivacine, 2) 2.5ml 0.5% levobupivacaine, or 3) placebo. One shot of these agents will be delivered by nerve block to maxillary and mandibular branches of trigeminal nerve before the incision was made. The degree of postoperative pain will be evaluated daily by visual analog scale for up to 3 days. The anticipated time on study is 1 year, and the target sample size is 40 individuals.
详细描述
Design of intervention vs. control Intra-operative injective of (chirocaine) before incision Location of injection: inferior alveolar nerve proximal to its entrance to ramus of mandible, maxillary nerve around pterygopalatine ganglion Amount of injection on each injection site: (1) Experimental group 1: 5mg/ml chirocaine 5cc (2)Experimental group 2: 5mg/ml chirocaine 2.5cc (3)Control group: normal saline 5cc. There are totally 4 injection sites for two jaw surgery and 2 injection sites for one jaw surgery. The experimental site and control site will be determined randomly before injection.
Outcome measurement
- Primary: effectiveness of intra-operative nerve block on post-operative pain control
- Secondary:
- whether the pain relieve effect is dose-related
- how long will this effect last
The intensity of post-operative pain will be measured by VAS, visual analog scale)daily until patients are discharged.
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
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients who will receive orthognathic surgery (one jaw or two jaw, with or without genioplasty) in Chang Gung Memorial Hospital since July 2011
排除标准
- •more complex (2- or more piece LeFort I osteotomy, combined gonial resection in BSSO, etc.) or less complex (only Wassmund and/or Kole osteotomies in upper or lower jaw) orthognathic procedures
- •unexpected fracture (unilateral)
- •intra-operative nerve injuries
- •significant facial asymmetry which demands different procedures (location of osteotomy, extension of muscle stripping, etc.)
- •cleft patient, post-traumatic patients, patients with craniofacial syndromes or other neurological or systemic problems which might interfere pain evaluation post-operatively
结局指标
主要结局
Postoperative pain
时间窗: participants will be followed for the duration of hospital stay, an expected average of 3days
The degree of pain will be measured daily by visual analog scale.
次要结局
- Effective duration of levobupivacaine nerve block(participants will be followed for the duration of hospital stay, an expected average of 3 days)