Comparison of Modified Programmed Intermittent Bolus (MPIB), Computer-integrated Patient Controlled Epidural Analgesia (CIPCEA) and Conventional Patient Controlled Epidural Analgesia (PCEA) During Labour
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 839
- 试验地点
- 2
- 主要终点
- Number of subjects with Breakthrough pain
研究概览
简要总结
Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, more than 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. Women who have increased pain tend to have lower successful patient bolus demands when patient controlled epidural analgesia (PCEA) is utilised and have dysfunctional labour requiring obstetric intervention such as Caesarean or instrumental delivery. Labour pain often escalates and worsens as labour progresses requiring an individualized, variable, flexible analgesic regimen. Bolus epidural administrations have been shown to improve uniform spread of local anaesthetics with better pain relief, compared to fixed background infusions.
详细描述
The research team developed two novel epidural delivery regimens: computer-integrated PCEA (CIPCEA) and modified programmed intermittent bolus (MPIB) focused on individualization of analgesic requirements. This phase 3 double-blinded randomized controlled trial will compare the two novel regimens, and each with conventional PCEA with basal infusion (BI), in reducing breakthrough pain (failure of the regimen to provide adequate pain relief, necessitating unscheduled epidural supplementation) incidence as the primary outcome in nulliparous term women requesting labour epidural analgesia. In addition, a discrete choice experiment (DCE) in the format of a survey will be administered to estimate the women's preferences in treatment attributes related to epidural analgesia, including control over epidural dosage, chance of having breakthrough pain, motor block, instrumental delivery and out-of-pocket cost for epidural analgesia. We will also look into the association model for breakthrough pain that would take into account pre-delivery factors to better understand the mechanism of breakthrough pain during labor process.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy (ASA physical status 1 and 2) nulliparous parturients at term (≥36 weeks gestation);
- •Singleton foetus
- •Early labour (cervical dilation ≤5cm)
- •Request labour epidural analgesia
- •At least 21 years of age
排除标准
- •parturients with multiple pregnancies
- •non-cephalic foetal presentation
- •obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes, gestational diabetes on insulin) and uncontrolled medical (e.g. cardiac disease) complications
- •have contraindications to neuraxial blockade or have received parenteral opioids with the last 2 hours.
研究组 & 干预措施
MPIB modified programmed intermittent bolus
Modified programmed intermittent bolus (MPIB) up-down frequency of 5mls ropivacaine/fentanyl solution in bolus with epidural delivery system
干预措施: Ropivacaine (Drug)
MPIB modified programmed intermittent bolus
Modified programmed intermittent bolus (MPIB) up-down frequency of 5mls ropivacaine/fentanyl solution in bolus with epidural delivery system
干预措施: Fentanyl (Drug)
CIPCEA
computer integrated patient controlled epidural analgesia (CIPCEA) up-down variable basal infusion of ropivacaine/fentanyl solution with epidural delivery system
干预措施: Fentanyl (Drug)
MPIB modified programmed intermittent bolus
Modified programmed intermittent bolus (MPIB) up-down frequency of 5mls ropivacaine/fentanyl solution in bolus with epidural delivery system
干预措施: epidural delivery system (Device)
CIPCEA
computer integrated patient controlled epidural analgesia (CIPCEA) up-down variable basal infusion of ropivacaine/fentanyl solution with epidural delivery system
干预措施: epidural delivery system (Device)
patient controlled epidural analgesia with basal infusion
patient controlled epidural analgesia (PCEA) with fixed basal infusion of ropivacaine/fentanyl solution with epidural delivery system
干预措施: epidural delivery system (Device)
CIPCEA
computer integrated patient controlled epidural analgesia (CIPCEA) up-down variable basal infusion of ropivacaine/fentanyl solution with epidural delivery system
干预措施: Ropivacaine (Drug)
patient controlled epidural analgesia with basal infusion
patient controlled epidural analgesia (PCEA) with fixed basal infusion of ropivacaine/fentanyl solution with epidural delivery system
干预措施: Ropivacaine (Drug)
patient controlled epidural analgesia with basal infusion
patient controlled epidural analgesia (PCEA) with fixed basal infusion of ropivacaine/fentanyl solution with epidural delivery system
干预措施: Fentanyl (Drug)
结局指标
主要结局
Number of subjects with Breakthrough pain
时间窗: 1 day
Unscheduled epidural supplementation by anaesthetist due to pain
次要结局
- Willingness to pay(1 day)
- Number of subjects with Caesarean section(1 day)
- Foetal outcome(1 day)
- Number of subjects with Instrumental delivery(1 day)
- Factors associated with epidural decisions(1 day)
- Pain vulnerability: Pain Catastrophizing Scale(1 day)
- Sub-acute pain after childbirth(5-9 weeks)
- Edinburgh Postnatal Depression Scale before and after delivery(5-9 weeks)
研究者
Sng Ban Leong
Principal Investigator
KK Women's and Children's Hospital