Acupuncture Randomized Trial for Post Anaesthetic Recovery and Postoperative Pain - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- The primary objective is the assessment of the effects of permanent needle acupuncture at 12 acupuncture points for improving post anaesthetic recovery.
研究概览
简要总结
In the present study, the investigators want to evaluate if press needle acupuncture applied prior to surgery may contribute to the anaesthesiologic outcome. Acupuncture might improve fast-track anaesthesia in the PACU after general surgery.
详细描述
The use of complementary approaches, especially acupuncture, has gained momentum within the last decade. In this regard, it might be appropriate to develop a simply applicable (a) and effective (b) acupuncture regimen for the complementary support of fast-track anaesthesia. Regarding practicability (a), it might be of interest to reduce the amount of necessary acupuncture points. Trials have shown that single-point acupuncture is strong enough to cause relevant clinical effects (Fleckenstein et al., 2009; Lee and Fan, 2009). In addition, practicability means to reduce the amount of needling events; therefore the investigators suggest the use of press needles, making complete peri-anaesthetic availability possible. Regarding effectiveness (b), it has been reported that acupuncture at Governing Vessel 26 (Du-26) may be successful in shock resuscitation (Hsu et al., 2006). In combination with other points it has been evaluated in a Chinese study improving the vegetative state after operation of acute subdural hematoma (Zheng, 2005).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled for laparoscopic surgery of uterus, adnex or ovaries
- •ASA-score ≤ 2
- •Subjects with the ability to follow study instructions and likely to attend and complete all required visits
- •Written informed consent of the subject
排除标准
- •General Exclusion Criteria:
- •Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- •Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of acupuncture within 30 days prior to clinical trial beginning
- •Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial
- •Known or persistent abuse of medication, drugs or alcohol
- •Exclusion criteria regarding special restrictions for females:
- •Current or planned pregnancy or nursing women
- •Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases.
- •Indication specific exclusion criteria:
- •Subjects will not be included in the study if any of the following criteria applies:
- •Surgery within the last three months
- •Chronic pain > 3 month
- •Continuous analgesic medication with opioids longer than 3 days
- •Massive degenerative diseases
- •Pre-treatment with acupuncture or trigger point injection within the last 2 months
结局指标
主要结局
The primary objective is the assessment of the effects of permanent needle acupuncture at 12 acupuncture points for improving post anaesthetic recovery.
时间窗: The time from extubation to "Ready for discharge" (in minutes) will followed for the duration in the recovery unit, an expected average of 1 hour
Time from extubation to "Ready for discharge" (in minutes) from the PACU as assessed by the Aldrete score, the Post Anaesthetic Discharge Scoring System (PADSS) and our 'in-house' scoring system when comparing the acupuncture group and the standard treatment group.
次要结局
- Variables in PACU(Patients will be followed for the duration of their stay in the recovery unit, , an expected average of 1 hour)
- Preoperative Variables(2 days, ends when anaesthesia starts)
- Postoperative variables(Patients will be followed for the duration of hospital stay follwing the recovery unit, an average of 2 days)
- Perioperative Variables(Patients will be followed for the duration of the surgical procedure, an expected average of 2 hours)
研究者
Dr. Johannes Fleckenstein
Principal Investigator
Ludwig-Maximilians - University of Munich