Acupuncture vs. Placebo Acupuncture and vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Pain intensity as measured by Numeric Rating Scale 1-10
研究概览
简要总结
The study entitled "Acupuncture vs. placebo acupuncture and vs. standard therapy for pain control after elective caesarian section - a randomized controlled trial" aims to investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement as compared to placebo and standard therapy in patients after after elective caesarian section (CS) in the period from January 2015 to May 2016.
For that purpose 180 adult patients scheduled to elective elective CS in spinal anesthesia will be recruited according to eligibility criteria. 120 patients will be randomized either to verum or placebo acupuncture, 60 patients will be included in non-randomized "standard therapy" arm. The outcome measures are: postoperative analgesic requirement, pain intensity, incidence of side effects and physiological parameters.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with an American Society of Anaesthesiologists physical status of I to III scheduled for elective caesarean section in spinal anaesthesia
- •Surgery time does not exceed 60 minutes
- •Patients without previous opioid and psychotropic medication
- •Patients ranged 19-45 years old
- •Patients who have given written informed consent
排除标准
- •Recidivist alcoholics
- •Local skin infection at the sites of acupuncture
- •Age < 19 and > 45 years
- •Switching to general anaesthesia in cases where spinal anaesthesia fails
- •Surgery time more than 60 minutes
- •Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines except for short hypotension after induction of spinal anaesthesia )
- •Patients who consumed opioid medication at least 6 months before surgery
- •Patients who are unable to understand the consent form and fill in the study questionnaire
- •History of psychiatric disease
研究组 & 干预措施
Verum acupuncture
Each patient will receive 16 permanent indwelling acupuncture needles, embedded in adhesive tape, bilaterally in addition to standard postoperative analgesia
干预措施: Standard therapy (Drug)
Verum acupuncture
Each patient will receive 16 permanent indwelling acupuncture needles, embedded in adhesive tape, bilaterally in addition to standard postoperative analgesia
干预措施: Verum acupuncture (Device)
Placebo acupuncture
Each patient will receive 16 adhesive tapes mimicking the indwelling acupuncture needles bilaterally in addition to standard postoperative analgesia
干预措施: Standard therapy (Drug)
Placebo acupuncture
Each patient will receive 16 adhesive tapes mimicking the indwelling acupuncture needles bilaterally in addition to standard postoperative analgesia
干预措施: Placebo acupuncture (Other)
Standard therapy
Each patient will receive just standard postoperative analgesia
干预措施: Standard therapy (Drug)
结局指标
主要结局
Pain intensity as measured by Numeric Rating Scale 1-10
时间窗: 4:00 P.M. on the 1st postoperative day
次要结局
- Incidence of complications and adverse effects(4:00 P.M. on the 2nd postoperative day)
- Total requirement of postoperative analgesics(4:00 P.M. on the 2nd postoperative day)