A Randomized Clinical Study to Compare the Number of Physician Top-up Interventions During the First Stage of Labour Between Two Different Neuraxial Analgesia Techniques: the Dural Puncture Epidural and the Standard Epidural
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Need for 1 physician epidural top-up
研究概览
简要总结
The purpose of this prospective randomized controlled study is to compare the number of physician top-up interventions during the first stage of labour between two different neuraxial analgesia techniques : the dural puncture epidural and the standard epidural.
详细描述
Providing adequate labour analgesia has always been an important issue in obstetrical anesthesia. Different types of neuraxial techniques include standard epidural analgesia (EPL), combined spinal epidural analgesia (CSE) and dural puncture epidural analgesia (DPE). DPE, which has gained in popularity in recent years, is similar to CSE in which the dura mater is punctured, however without injection of medication in the cerebrospinal fluid (CSF). Recent studies have found benefits of the DPE technique, such as less fetal bradycardia than CSE, better bilateral sacral analgesia than EPL and faster onset than EPL. No study has yet compared DPE to EPL when an ultra-low concentration of local anesthetic protocol is used for maintenance of analgesia. We hypothesize that in term primiparous and multiparous parturients, a dural puncture epidural technique will improve labour analgesia quality during the first stage of labour (based on physician top-up interventions) compared with a standard epidural technique when a patient-controlled epidural analgesia (PCEA) with ultra-low concentration epidural mixture classically used in our institution based on our hospital orders and national guidelines.
The main hypothesis for this study is to show that there will be 50% reduction in the incidence of parturients in need of at least one physician top-up intervention during the first stage of labour in the DPE group compared to the EPL group.
The patients will be approached by the anesthesia research team upon arrival at the birth unit. The randomization will be done at the time the parturient requests an epidural. Randomization will be done in a 1:1 ratio until we reach 65 subjects in each group.
Before neuraxial catheter placement, a 20G or 18G intravenous (IV) catheter is inserted and standard monitoring is applied.
The attending or resident in anesthesiology will place the neuraxial catheter following the next steps :
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant women (ASA 1 and 2) requesting epidural analgesia during labour.
- •Primiparous and multiparous parturients at term gestation (37 to 42 weeks).
- •Women 18 years old and older.
- •Administration of epidural analgesia between 7am and 4pm on weekdays.
- •Singleton and vertex presentation foetus.
- •Cervical dilatation ≤ 5 cm.
- •French speaking
排除标准
- •Pregnancy diseases such as gestational hypertension, preeclampsia and gestational diabetes.
- •Contraindications to neuraxial analgesia: thrombocytopenia < 70 x 109/L, spinal cord anomalies, anticoagulation therapy, etc.
- •Known important fetal anomalies.
- •Allergy to any of the medications used in the study.
- •Suspected chorioamnionitis with spontaneous premature rupture of membranes (PROM).
- •Difficulty understanding and speaking French.
研究组 & 干预措施
Dural puncture epidural (group DPE)
The epidural space will be identified in the seated position between the L2 and L5 interspaces with a 17G-10 cm Tuohy epidural needle (CHS ®, Oakville, ON, Canada) using a loss of resistance to saline technique. In both groups, a needle-through-needle technique will be performed using a 25G 5-inch Whitacre spinal needle (BD®, Franklin Lakes, NJ, USA). In group DPE, a single dural puncture with confirmation of free-flow CSF will be performed. If there is no free-flow CSF return through the spinal needle, the epidural catheter will be threaded 4-5cm in the epidural space and the patient will still be assigned to the DPE group, as per "intent-to-treat" protocol.
干预措施: Dural puncture epidural (Procedure)
Standard epidural (group EPL)
The epidural space will be identified in the seated position between the L2 and L5 interspaces with a 17G-10 cm Tuohy epidural needle (CHS ®, Oakville, ON, Canada) using a loss of resistance to saline technique. In both groups, a needle-through-needle technique will be performed using a 25G 5-inch Whitacre spinal needle (BD®, Franklin Lakes, NJ, USA).In Group EPL, no dural puncture will be performed and the catheter will be threaded 4-5cm in the epidural space.
干预措施: Standard epidural (Procedure)
结局指标
主要结局
Need for 1 physician epidural top-up
时间窗: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
The number of parturients who need at least one physician top-up intervention during the first stage of labour.
次要结局
- Number of physician epidural top-ups(Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.)
- Urinary catheterisation(Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.)
- Asymetrical block(Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.)
- Timing of physician top-ups(Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.)
- Ambulation(Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.)
- Analgesia scores(Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.)
- Sacral block(Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.)
- Patient satisfaction(Up to 48 hours after inclusion.)
- Motor block(Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.)
- Ambulation criteria(Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.)
- Local anesthetic and fentanyl doses(Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.)
研究者
Philippe Richebe
Principal Investigator
Ciusss de L'Est de l'Île de Montréal