Acupuncture for Post-hemorrhoidectomy Pain Control With Acute Anti-inflammatory Effects: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Maximal pain intensity
研究概览
简要总结
The goal of this clinical trial is to learn if acupuncture improves pain control after hemorrhoidectomy in patients with symptomatic hemorrhoids. It will also learn about the safety of using acupuncture in surgical patients. The main questions it aims to answer are:
Does acupuncture lower the maximal pain intensity after hemorrhoidectomy? Does acupuncture reduce analgesics requirement, length of hospital stay and quality of recovery?
Researchers will compare fully active acupuncture to a sham treatment (a look-alike procedure with minimum acupuncture stimulation) to see if active acupuncture works to improve pain control.
Participants will:
Receive acupuncture treatment for 7 times over first 5 days after surgery. Visit the clinic once 2 weeks after surgery for checkups and tests. Keep a diary of their symptoms and the number of times they take pain-killers.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic grade III or IV hemorrhoids undergoing conventional hemorrhoidectomy
排除标准
- •Patients scheduled for stapled hemorrhoidopexy
- •Concomitant surgery other than conventional hemorrhoidectomy
- •Bleeding tendency, thrombocytopenia (platelet count < 100 x 10^9/L)
- •Immunocompromised status or use of chemotherapy
- •Active dermatitis
- •Patients with pacemaker or automated implantable cardioverter-defibrillator
- •Pregnant patients
- •Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including cyclooxygenase-2 inhibitors
- •History of chronic pain (duration for 3 months or more)
- •Daily use of strong opioids (e.g. morphine, fentanyl, hydromorphone, methadone, oxycodone, or meperidine)
- •Alcohol or drug abuse
- •Psychiatric illness
- •Impaired renal function (preoperative serum creatinine level > 120µmol/L)
- •Recent acupuncture treatment for other medical conditions
研究组 & 干预措施
Fully active acupuncture
干预措施: Acupuncture (Procedure)
Minimum acupuncture stimulation
干预措施: Acupuncture (Procedure)
结局指标
主要结局
Maximal pain intensity
时间窗: Post-operative day 1
Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 means 'worst pain')
次要结局
- Dosage of analgesics requirement(Post-operative 2 weeks)
- Maximal and resting pain intensity(Post-operative day 0, 2 to 7 and 14)
- Length of hospital stay(Post-operative day 1)
- Serum C-reactive protein level(Post-operative day 0 and 1)
- Maximal and resting pain intensity(Post-operative day 0, 2 to 7 and 14)
- Length of hospital stay(Post-operative day 1)
- Dosage of analgesics requirement(Post-operative 2 weeks)
- Functional recovery questionnaire(Post-operative 1 week (time to first bowel motion, time to first urination and time to return to work, counted from the day of operation))
- Adverse effect(Post-operative 2 weeks)
- Quality of recovery (QoR)(Post-operative day 1)
- Serum C-reactive protein level(Post-operative day 0 and 1)
研究者
Pak Chiu WONG
Associate Consultant
The University of Hong Kong