Sacral Anesthetic Block During Labor Analgesia With a With a 27-G Whitacre Spinal Needle - Dural Puncture Epidural Technique vs Standard Epidural Technique: a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Evaluation of sensitive block through a pin-prik test in lumbar and sacral dermatomes.
研究概览
简要总结
Neuraxial labor analgesia is a very widely used technique for labor pain relief with a high efficacy and safety. EA (Epidural analgesia) can guarantee a proper control of pain in 95-100% of cases in the first stage of labor, but in the second stage his efficacy is not always adequate. DPEA (Dural Puncture Epidural Analgesia) is a variation of the conventional EA and technically a modified version of the CSE (Combined Spinal Epidural) analgesia.
When compared with the traditional EA, DPEA showed satisfying, effective and fast control of labor pain, no motor block and less need for anesthetic boluses given through the epidural catheter when the maintenance of analgesia was guaranteed with manual top-ups, as well as less request for extra boluses of anesthetic when PIEB (Programmed Intermittent Epidural Boluses) was chosen for the maintenance of analgesia. Studies proved that DPEA is a safe technique and no statistically significant incidence of side effects for mothers and fetuses was observed.
The hypothesis of this study is that a DPEA performed with a 27 G Whitacre spinal needle can especially improve the spread in the sacral region.
The primary outcome of this study is to evaluate whether the DPEA performed with a 27-G Whitacre spinal needle is more effective in ensuring satisfying analgesia as a result of a better sacral analgesic spread, compared to the traditional EA.
详细描述
Labor pain is acute pain, with a sudden onset, limited duration, high intensity and an evolving character consisting of a visceral and a somatic component1. Many dermatomes are involved, unlike other pain syndromes.
In the first stage of labor, pain is caused by the contraction of the uterine fibers and by the stretching and dilation of the cervix and the lower uterine segment. When labor proceeds towards the active phase of the first stage, corresponding to a dilation of 3-4 cm, the pain becomes more severe, and extends to the contiguous dermatomes T10 and L1. The pain generated at this moment is visceral, dull, indistinct, difficult to locate, "referred" to skin areas far from the site of pain stimulation and most of the time as "back pain". When the uterine cervix is fully dilated, the second stage of labor begins: the pain is due to the distension and stretching of the perineal structures in conjunction with fetal progression. This late pain originates from the perineum (deep somatic pain) and is conducted by type A-delta and C somatic myelin fibers, that through the pudendal nerves reach the posterior horns of the spinal cord via the posterior roots of the 2nd, 3rd and 4th sacral nerve.
Currently, neuraxial analgesia is a very widely used technique for labor pain relief with a high efficacy and safety. Neuraxial analgesia is administered through:
- continuous or intermittent epidural block
- continuous or single shot spinal or subarachnoid block
- combined spinal-epidural block (CSE). DPEA (Dural Puncture Epidural Analgesia) is a modified version of the CSE analgesia technique and at the same time a combination of CSE and EA (Epidural Analgesia). Despite the similarities, the management of labor analgesia with these techniques is profoundly different. DPEA does not allow the same rapid onset of CSE analgesia, since the administration of the intrathecal dose is omitted, but the induction and maintenance of analgesia are guaranteed by the epidural catheter as in the standard AE.
EA (Epidural analgesia) can guarantee a proper control of pain in 95-100% of cases in the first stage of labor, but in the second stage his efficacy is not always adequate.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparous;
- •36 - 42 gestational week;
- •active stage of labor;
- •less than 5 cm cervical dilatation.
排除标准
- •< 18 years;
- •ASA > 2;
- •refusal of informed consent;
- •known fetal pathologies;
- •conditions that contraindicate the execution of neuro axial analgesia techniques;
- •uterine anomalies or previous uterine surgery;
- •severe obesity;
- •twin pregnancy;
- •non-vertex fetal presentation.
结局指标
主要结局
Evaluation of sensitive block through a pin-prik test in lumbar and sacral dermatomes.
时间窗: 20 minutes after completion of anesthesia.
Efficacy of sacral anesthetic block through a pin-prik test (0= no sensitive block, 2= complete block) in lumbar and sacral dermatomes: stimulation of the inguinal ligament (L1), the anterior portion of the thigh (L2), the medial surface of the knee (L3), the medial malleolus (L4), the back of the foot in the space between the first two metatarsal rays (L5), the lateral surface of the heel (S1) and the medial popliteal fossa (S2).
次要结局
- Supplemental analgesia requirement(20 minutes after delivery.)
- Change of pain relief(10 minutes, 20 minutes, 30 minutes and then every 1 hour after completion of anesthesia.)