Acupuncture for Postoperative Analgesia in Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Time to First Analgesic Request
研究概览
简要总结
Auricular (ear) acupuncture treatment involves placing filiform needles in the ears at particular locations called acupoints. Although the mechanism for acupuncture analgesia is still unclear, it is believed ear acupoints work like reflex points that once stimulated with penetration by a needle have the ability to relieve pain in a different part of the body.
The purpose of this study is to explore the safety and effects of auricular acupuncture therapy on postoperative analgesic consumption and pain scores immediately following laparoscopic surgery.
详细描述
Auricular acupuncture is a diagnostic and treatment system associated with a somatotopic representation of the homunculus in the ear. This acupuncture technique is similar, in theory, to reflexology where stimulation of a reflex point in the ear is presumed to relieve symptoms in another part of the body. It is hypothesized that this technique works to decrease pain through the reticular formation, the sympathetic and the parasympathetic nervous systems.
The increasing use of laparoscopic surgery has significantly diminished the dosing and duration of postoperative opioid consumption compared with open surgery. However, adverse events related with opioid use (nausea & vomiting, pruritus, urinary retention, sedation) may cause delays in hospital discharge and can be especially problematic for certain sub-sets of high risk patients such as those with obstructive sleep apnea or prior histories of addiction. Investigators hypothesize that auricular acupuncture using the Battlefield Acupuncture Protocol will decrease opioid consumption and postoperative pain after laparoscopic surgery with minimal or no adverse events.
The primary aim of this study is to assess the effects of the BFA protocol on postoperative analgesic consumption and the secondary aims are to assess pain scores and time to discharge from Post Anesthesia Care Unit following laparoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing laparoscopic surgery for cholecystectomy, hysterectomy or hernia repair
- •Patients naïve to acupuncture
排除标准
- •Pregnancy
- •Bleeding disorder
- •Anticoagulant medications
- •Involuntary movement disorders/Seizure disorders
- •Local auricular infection, loss of skin integrity or significant deformation
- •History of opioid medication use or dependence
- •Hemodynamic or immunocompromised status
- •History of syncope with venipuncture
- •Unable to understand the consent form or how to use the VAS-100
- •Prosthetic cardiac valves
- •Patients will be withdrawn from the study if surgery time exceeds 90 minutes or the laparoscopic procedure turned into an open surgery
结局指标
主要结局
Time to First Analgesic Request
时间窗: Post Surgery (Up to 30 minutes)
The time to request for analgesia will be collected from the participant's postoperative anesthesia care unit (PACU) records.
Total Amount of Postoperative Pain Medication
时间窗: Post Surgery (Up to 2 Hours)
The total amount of pain medication taken up to two hours post surgery will be collected from the participant's postoperative anesthesia care unit (PACU) records.
Pain Intensity assessed by the Visual Analog Scale (VIS)
时间窗: Post Surgery (Up to 2 Hours)
Pain intensity will be recorded using the modified 100mm visual analog scale. This scale rates pain from 0 to 100 with 0 meaning no pain at all and 100 is the most severe pain.
次要结局
- Time to Discharge(Post Surgery (Up to 2 Hours))