A Trial to Determine the Optimal Bupivacaine Dose for Initiation of Labor Epidural Pain Relief With a Lidocaine Test Dose
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- NRS <3 at 30 min
研究概览
简要总结
The primary objective of our study is to use a biased coin up-down allocation methodology to estimate the dose of bupivacaine required after the lidocaine test dose to achieve initial effective comfort in 90% of patients (post test-dose ED90) via the epidural (DPE or EPL) technique in women undergoing labor induction or augmentation; the investigators hypothesize that the investigators will be able to determine the post test-dose ED90 of bupivacaine for each technique with adequate precision to inform the optimal doses to study in a subsequent randomized trial comparing the analgesic effects of DPE vs. EPL. The investigators also hypothesize that the post test-dose ED90 of bupivacaine is lower with a DPE technique than with a conventional epidural technique.
详细描述
The investigators will be conducting a randomized controlled trial with patients randomized into either an EPL or a DPE group. For the first subject in the DPE and EPL techniques, the initial dose of bupivacaine 25 mg will be used, with an endpoint being the achievement of an NRS < 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments. Hence, if the first subject does not respond successfully, the dose for the second subject will be bupivacaine 27.5 mg. If the second subject does not respond successfully, the dose for the third subject will be bupivacaine 30 mg. By contrast, if a subject responds successfully, the bupivacaine dose will be decreased to 22.5 mg with a probability of 10% and maintained with a probability of 90% (ratio 1:9).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Parturient with no major co-morbidities
- •Singleton, vertex gestation at term (37-42 weeks)
- •Less than or equal to 5 cm dilation
- •Desire to receive epidural labor analgesia
- •Numerical Rating Scale greater than or equal to 5 (NRS 0-10, where 0 = no pain, and 10 = worst pain imaginable), at time of epidural labor analgesia request.
排除标准
- •Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e., preeclampsia, gestational diabetes)
- •Any contraindication to the administration of an epidural technique (e.g., thrombocytopenia, antiplatelet meds).
- •History of hypersensitivity or idiosyncratic reaction to an amide local anesthetic agent
- •Evidence of anticipated fetal complications (i.e., fetal anomalies, IUGR (Intrauterine Growth Restriction), oligohydramnios, polyhydramnios)
研究组 & 干预措施
DPE Group
Subjects will receive an epidural catheter via a dural puncture epidural technique.
干预措施: Bupivacaine Hydrochloride (Drug)
EPL Group
Subjects will receive an epidural catheter via a traditional epidural technique.
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
NRS <3 at 30 min
时间窗: 30 minutes after time 0.
Adequate analgesia is defined as NRS score less than 3 at 30 minutes after time 0.
次要结局
未报告次要终点
研究者
Lawrence Ching Tsen
Associate Professor in Anaesthesia
Brigham and Women's Hospital