Ultrasound Guided Midline Continuous Spinal Anesthesia in the Elderly : is There an Advantage Over Conventional Landmark Paramedian Technique: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- the difference in number of needle passes between the two groups
研究概览
简要总结
Former clinical studies have reported the superiority of the landmark guided paramedian approach above the classical landmark guided midline approach for the continuous spinal anesthesia especially in the elderly. On the other hand, more recent clinical trials have suggested that the use of ultrasound to guide spinal anesthesia will be safer and more effective than the conventional palpation-guided technique.
The aim of this study will be to compare the conventional "blind" landmark paramedian approach to the ultrasound "modern" guided midline approach for the continuous spinal anesthesia in the elderly with hip fractures.
Patients will randomly divided into two groups:
Group(PML): will undergo conventional landmark guided paramedian continuous spinal anesthesia Group (MUS): will undergo ultrasound guided midline continuous spinal anesthesia
详细描述
All elderly patients above 65 years old scheduled for elective surgery for hip fracture under continuous spinal anesthesia will be included in the study.
Patients will randomly divided into two groups by using random number generating software (Research Randomizer Version 4.0) Group(PML): will undergo conventional landmark guided paramedian continuous spinal anesthesia Group(MUS) : will undergo ultrasound guided midline continuous spinal anesthesia A written informed consent will be obtained from all participants, who will be blinded as to their allocated group.
After establishing a baseline monitoring (3 lead ECG, pulse oximetry and non-invasive blood pressure) and an intravenous access, a fascia-iliaca ultrasound guided block at the fractured hip will be performed for all patients by the injection of 20 ml of 1.5 % lidocaine.
15 minutes later with the aid of an assistant, the patient will be positioned at the edge of the operating table in an arched back posture.
In both groups the continuous spinal anesthesia(CSA) will be performed with one of three anesthesiologists (two residents in their fourth year of training anesthesia and one associate professor), each have sufficient experience in performing neuraxial ultrasound scans prior to the study. To fulfill this they will use an 18 gauge Tuohy needle with a 22 gauge intrathecal catheter.
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
- None (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consented patients aged over 65 years old scheduled to undergo surgery for hip fracture under continuous spinal anesthesia with American Society of Anesthesiologists ASA physical status classification from I to III
排除标准
- •contraindications to spinal anesthesia ( allergy to local anesthetic, coagulopathy, infection at the site of injection)
- •previous history of lumbar spine surgery
- •per operative severe complication with conversion to general anesthesia
研究组 & 干预措施
Midline ultrasound group
preprocedural ultrasound guided midline approach will be performed. isobar bupivacaine will be injected for continuous spinal anesthesia.
干预措施: preprocedural ultrasound guided midline technique (Procedure)
paramedian landmark group
conventional landmark paramedian approach will be performed. isobar bupivacaine will be injected for continuous spinal anesthesia.
干预措施: conventional landmark paramedian technique (Procedure)
结局指标
主要结局
the difference in number of needle passes between the two groups
时间窗: from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin
the number of forward advancements of the Tuohy needle in a given interspinous space (i.e withdrawal and redirection of Tuohy needle without exiting the skin)
次要结局
- number of spinal needle insertion attempts(from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin)
- the rate of first pass success(from the first insertion of the needle until the fixation of the continuous spinal anesthesia catheter to patient skin)
- time for identifying landmarks(time taken from start of palpating or ultrasound scanning to the marking of the needle entry point)
- time taken for performing continuous spinal anesthesia(time taken from the start of the first insertion of the needle to the completion of fixation of the catheter to patient skin)
- incidence of continuous spinal anesthesia complications(from the star of first needle insertion to the completion of the continuous spinal anesthesia)
- the injection level(from the start of identifying landmarks until the patient leaves the operation room)
研究者
Sameh Ben Ahmed
Associate professor
University Tunis El Manar