Auricular Acupuncture As Part Of A Multimodal Analgesic Regimen For Reduction Of Opioid Analgesic Use After Surgery To Repair Lower Leg Fractures- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Total opioid analgesic use for 14 days after surgery
研究概览
简要总结
The purpose is to find out if incorporation of an intraoperative electro auricular acupuncture protocol when added to a standard multimodal analgesic regimen for patients undergoing surgery to repair lower leg fracture under spinal anesthesia will help reduce postoperative opioid use.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The patient will be under sedation during procedure, so will not be aware of whether or not they received acupuncture treatment.
Anesthesia team in the operating room will be aware of treatment. PACU team and outcomes assessor will not be aware of group assignment
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ages 18-64
- •American Society of Anesthesiology Physical Status I, II or III
- •Inpatients scheduled to undergo ankle ORIF at Harris Health System Ben Taub Hospital
排除标准
- •Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
- •Allergy to any of the standard anesthetic agents
- •Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
- •Patient or surgeon refusal
研究组 & 干预措施
Electroauricular acupuncture
Immediately after Level 2 sedation is achieved, an enhanced auricular trauma protocol (ATP) will be administered on the ear ipsilateral to the operative side at 8 ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) as described by Cheng (2022). The original ATP was described by Helms (2011). Seirin L 0.2 x 30 mm needles will be placed at Hypothalamus and Shen Men points. Seirin J 0.18 x 15 mm needles will be placed at Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Vagus, and Insula points. Electrostimulation using an ITO ES 130 microstimulator at 30 HZ with Level 4 intensity, will be applied with the positive lead (red) on Hypothalamus and negative lead (black) at Shen Men for 60 minutes. All needles will be removed 1 hour after insertion.
干预措施: Auricular acupuncture (Device)
No acupuncture
No acupuncture treatment given
结局指标
主要结局
Total opioid analgesic use for 14 days after surgery
时间窗: 14 days
Total opioid given in hospital and taken at home, converted to oral morphine equivalents
次要结局
- Incidence of side effects associated with opioid use(14 days)
- Pain scores(14 days)
研究者
Jaime Ortiz
Professor of Anesthesiology
Baylor College of Medicine