Auricular Acupuncture as Effective Pain Relief After Episiotomy: A Prospective Interventional Randomized Parallel Single-center Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
Background: Episiotomy is performed in up to 30% of vaginal deliveries. Previously, pain treatment following episiotomy has relied on non-steroid anti-inflammatory drugs (NSAID) as analgesics, whose use during breastfeeding remains controversial due of their transfer to the child through lactation. The aim of the study is to determine the effect of acupuncture on postpartal perineal pain following episiotomy.
Methods: The study is designed as a prospective interventional randomized parallel single-center study to evaluate the effects of auricular acupuncture on pain relief after episiotomy. The population will encompass 60 patients that have had mediolateral episiotomy performed during vaginal delivery, with 29 receiving acupuncture therapy and 31 not receiving acupuncture therapy for pain relief. NSAID analgesic therapy will be made available per request.
详细描述
Study Protocol The study is designed as a prospective interventional randomized parallel longitudinal single-center study to evaluate the effects of auricular acupuncture on pain relief after episiotomy conducted in the Department of Gynecology and Obstetrics, University Hospital Center Sestre milosrdnice, Zagreb, Croatia. This institution performs up to 3100 deliveries per year. Episiotomy is indicated and performed in 30% of them.
Prospective data will be collected from November 2016 to April 2017. The study will include healthy pregnant women over 18 years of age, a minimum of 36 weeks' gestation that underwent mediolateral episiotomy during vaginal delivery. Sixty patients will be included in the study. Half of patients will be treated with auricular acupuncture for episiotomy pain relief and oral analgesics, while the other half will be treated with oral analgesics only. In both groups, administration of oral analgesics was recorded. The patients will be allocated to the groups by using a heads-tails coin toss.
In this study, auricular acupuncture will be used. The acupuncture treatment consists of three acupuncture needles on the dominant ear according to French auriculotherapy guidelines - internal genital area, external genital area and Shen Men point that is used to increase the anaesthetic effect according to both French and Chinese traditions (14,15). Acupuncture needles will be stimulated by manual rotation of the needle to evoke needle sensation De Qi. No electrostimulation will be used. Sterile 0,2 x 1,4 mm needles were used. The needles will be inserted within 6-8 hours after childbirth by a certified acupuncturist. The needles will be left in place until the hospital discharge of the patient on the third postpartal day, and removed by a certified acupuncturist.
Additional oral analgesics (NSAID) could be supplied at any time upon patients request during hospitalization. Oral ibuprofen would be given as first line therapy, while oral paracetamol would be given as second line therapy.
Primary outcome measures will be pain intensity (VAS score) immediately after birth, 2 hours after birth, during the first 3 days-at rest and activity. Secondary outcome measures will be the need for analgesics, the amount of given analgesics, and the number of analgesic repetitions during the day.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •healthy pregnant women over 18 years of age
- •a minimum of 36 weeks' gestation
- •patients that underwent mediolateral episiotomy during vaginal delivery
排除标准
- •any illness diagnosed during pregnancy
- •unwillingness to submit to acupuncture therapy
研究组 & 干预措施
Ear Acupuncture and Oral Analgesics
The acupuncture treatment consisted of three acupuncture needles on the dominant ear according to French auriculotherapy guidelines - internal genital area, external genital area and Shen Men point that is used to increase the anaesthetic effect according to both French and Chinese traditions.
Additional oral analgesics (NSAID) could be supplied at any time upon patients request during hospitalization. Oral ibuprofen was given as first line therapy, while oral paracetamol was given as second line therapy.
干预措施: Ear acupuncture (Procedure)
Oral Analgesics Only
Postoperative standard oral analgesic therapy (NSAID) supplied at any time upon patients request during hospitalization. Oral ibuprofen would be given as first line therapy, while oral paracetamol would be given as second line therapy.
干预措施: Analgesics (Drug)
结局指标
主要结局
Pain relief
时间窗: Immediately after birth, 2 hours after birth, during the first 3 days-at rest and activity.
Level of pain intensity measured by VAS - Visual Analogue Scale score ranging from 1 (smallest pain level) to 10 (highest pain level).
次要结局
- Oral analgesics amount(First 3 postpartal days.)
- Postpartum bleeding and pain due to uterine contractions(First 3 postpartal days.)
- Number of analgesic repetitions during the day.(First 3 postpartal days.)
研究者
Andro Košec, MD, PhD
Consultant in Otorhinolaryngology and Head and Neck Surgery
University Hospital "Sestre Milosrdnice"