Dural Pubcture Epidural Performed With Two Different Sized Spinal Needles vs Conventional Epidural Technique: a Triple Randomized Comparison to Evaluate Quality of Labor Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Quality of analgesia
研究概览
简要总结
DPEA (Dural Puncture Epidural Analgesia) is an alternative to the conventional epidural analgesia and technically a Combined Spinal Epidural (CSE) with omission of intrathecal drugs administration.
To date, literature has proved several advantages of the DPEA techniquecompared to conventional epidural.
However, these advantages are supposed to be limited to the use of 25 Gauge spinal needles.
The aim of this project is to compare the quality of analgesia achieved after a DPEA technique performed with a 25 Gauge spinal needle versus a 27 Gauge spinal needle versus a conventional epidural, with a PIEB pump installed for analgesia maintenance.
The Primary outcome will be the quality of analgesia, defined as the area under the curve (AUC) of the Numeric Pain Rating Scale (NPRS 100-0) ≤ 30 measured throughout labor and divided by labor duration (TWA-NPRS).
240 nulliparous women between the 36th and 42nd gestational week in active labor and with a cervical dilation ≤ 5 cm will be randomized according to a computer-generated random number sequence to receive a DPEA with a 25 Gauge spinal needle, a DPEA with a 27 Gauge spinal needle, or a conventional epidural.
详细描述
DPEA (Dural Puncture Epidural Analgesia) is an alternative to the conventional epidural analgesia and technically a Combined Spinal Epidural (CSE) with omission of intrathecal drugs administration.
Analgesia is achieved through the effect of epidural agents and their partial translocation into the intrathecal space.
To date, literature has proved several advantages of the DPEA technique, such as confirmation of epidural needle placement and lower rates of malfunctioning epidural catheters with reduced need for their manipulation or resiting. Overall, DPEA seems to mitigate some limitations of the conventional epidural technique while reducing the side effects associated with the CSE technique (fetal bradycardia, uterine hypertonus and pruritus).
However, these advantages are supposed to be limited to the use of atraumatic 25 Gauge spinal needles, and evidence mostly come from studies that compared the DPEA performed with 25 Gauge or 27 Gauge spinal needles with the conventional epidural or with the CSE.
The only direct comparison between two spinal needles of different sizes as part of a DPEA technique (25 vs 27 Gauge) was published by Contreras et al in 2019, who evaluated the onset time of the analgesic effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparous women
- •between the 36th and 42nd gestational week
- •active labor and with a cervical dilation ≤ 5 cm
排除标准
- •age < 18 years
- •ASA status > 2
- •patient's refusal
- •known fetal pathologies
- •contraindications to neuraxial techniques
- •uterine anomalies or previous uterine surgery
- •twinning and fetal malpresentation (non cephalic).
研究组 & 干预措施
DPEA 27G
Patients in the DPEA 27G group will receive an intentional dural puncture with a 27 Gauge Whitacre spinal needle, using the needle-through-needle technique (the epidural space will be identified using a 18 Gauge Tuohy needle).
干预措施: Dural Puncture Epidural Analgesia 27G (Device)
DPEA 25G
Patients in the DPEA 25G group will receive an intentional dural puncture with a 25 Gauge Whitacre spinal needle, using the needle-through-needle technique (the epidural space will be identified using a 18 Gauge Tuohy needle).
干预措施: Dural Puncture Epidural Analgesia 25G (Device)
Epidural
Patients in the Epidural group will receive a conventional epidural (the epidural space will be identified using a 18 Gauge Tuohy needle).
干预措施: Conventional epidural (Device)
结局指标
主要结局
Quality of analgesia
时间窗: From the beginning of analgesia to the end of labour
Time-Weighted Average Area Under the Curve (TWA-AUC) of Numeric Pain Rating Scale (NPRS 100-0) during labour.
次要结局
未报告次要终点