Postpartum Perineal Pain After Obstetric Anal Sphincter Injuries: A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
研究概览
简要总结
Obstetric anal sphincter injuries (OASIS) encompass both third and fourth degree perineal tears. These tears can have a significant impact on women's quality of life in the short and long term. One of the most distressing immediate complications of this severe perineal injury is perineal pain. Women can also experience postpartum depression, dyspareunia, and altered sexual function after OASIS.
This is a randomized controlled trial to study the effects of three interventions (placebo, low dose intravenous ketamine plus epidural morphine, or epidural morphine alone) on acute pain after OASIS.
The objective of this study is to assess the incidence of perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, 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
- •Age >18 years of age
- •English-speaking
- •Vaginal delivery (spontaneous or assisted)
- •A full-term fetus (>37 weeks' gestation)
- •OASIS as assessed by obstetrical provider
- •Functional epidural analgesia at time of delivery
- •Patient amenable to follow-up in specialty perineal clinic within the first week postpartum
排除标准
- •Previous pelvic surgery
- •History of chronic pelvic pain
- •History of recurrent urinary tract infections
- •Women with known malformations of their urinary tract
- •True allergies to ketamine and/or morphine
- •Preeclampsia or hypertensive disorder at the time of delivery
- •Obstructive sleep apnea
研究组 & 干预措施
Epidural saline + IV saline
Sterile saline via the epidural catheter. Sterile saline via intravenous catheter.
干预措施: Epidural saline + IV saline (Drug)
Epidural morphine 3 mg + IV saline
3 milligrams morphine via the epidural catheter. Sterile saline via intravenous catheter.
干预措施: Epidural morphine 3 mg + IV saline (Drug)
Epidural morphine 3 mg + IV ketamine 0.3 mg/kg
3 milligrams morphine via the epidural catheter. Ketamine 0.3 milligrams per kilogram via intravenous catheter.
干预措施: Epidural morphine 3 mg + IV ketamine 0.3 mg/kg (Drug)
结局指标
主要结局
Perineal pain in postpartum patients 1 week after obstetric anal sphincter injuries.
时间窗: 1 week after vaginal delivery
Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain and 10 highest pain.
Perineal Pain in Postpartum Patients 1 Week After Obstetric Anal Sphincter Injuries.
时间窗: 1 week after vaginal delivery
Perineal pain 1 week after vaginal delivery measured using the VRS (verbal rating scale). The scale is scored 0 no pain (good)and 10 highest pain (poor).
次要结局
- Brief Pain Inventory (Short Form) Modified(3 months after delivery)
- Promis 29 profile(3 month)
- Assessment of maternal-infant bonding(3 months after delivery)
- Maternal quality of life(3 months after delivery)
- Presence of postpartum depression(6 weeks after delivery)
- Medoc Pathway Device Score(1 week post delivery)
- Female sexual function(3 months after delivery)
- Perineal Pain(1 year after delivery)
- Perineal Pain(Day 1 after delivery)
- Perineal Pain(1 week after delivery)
- Assessment of Maternal-infant Bonding(1 week after delivery)
- Presence of Postpartum Depression(1 week after delivery)
- Brief Pain Inventory (BPI-ST Short Form) Current Pain(1 week after delivery)
- Presence of Postpartum Depression(6 weeks after delivery)
- Perineal Pain(6 weeks after delivery)
- Assessment of Maternal-infant Bonding(6 weeks after delivery)
- Brief Pain Inventory (BPI-ST Short Form) Current Pain(6 weeks after delivery)
- Perineal Pain(3 months after delivery)
- Assessment of Maternal-infant Bonding(3 months after delivery)
- Female Sexual Function(3 months after delivery)
- Brief Pain Inventory (BPI-ST Short Form) Current Pain(3 months after delivery)
- Promis 29 Profile (Physical Function Question Only)(3 month)
- Promis 29 Profile (Anxiety Function Question Only)(3 month)
- Promis 29 Profile (Depressive Symptoms Question Only)(3 month)
- Promis 29 Profile (Fatigue Question Only)(3 month)
- Promis 29 Profile (Sleep Disturbance Question Only)(3 month)
- Promis 29 Profile (Social Function Question Only)(3 month)
- Promis 29 Profile (Pain Interference Question Only)(3 month)
研究者
Feyce M. Peralta, MD, MS
Principal Investigator
Northwestern University