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临床试验/NCT06184425
NCT06184425已完成不适用

A Randomized Comparative Study Between 25-Gauge and 27-Gauage Pencil Point Spinal Needles During Dural Puncture Epidural Anaesthesia For Elective Caesarean Section

Reham Ali Abdelhaleem Abdelrahman1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2023年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
110
试验地点
1
主要终点
was the onset time to surgical anesthesia

研究概览

简要总结

DPE technique was performed by creating a perforation in the dura mater using a pencil point spinal needle (25-27G) through the shaft of an epidural needle. After the dural perforation was created and the free flow of the cerebrospinal fluid (CSF) was confirmed, which was considered a definitive end point for the likely positioning of the epidural needle tip within the epidural space, and by avoiding direct intrathecal administration of medication making DPE technique of fewer adverse effects in comparison to CSE technique, then spinal needle was withdrawn without local anesthetic injection into the subarachnoid space and the epidural catheter was normally placed in the epidural space followed by injecting local anesthetics into the epidural space via the epidural catheter, where the dural puncture created a conduit for translocation of local anesthetics from the epidural space to the subarachnoid space which was a unique feature of DPE technique.

Our study assessed the efficacy of DPE with pencil point spinal needle (25-27 G) during elective CS. Primary outcome was the onset time of surgical anesthesia which is defined as the time from the end of the initial dose injection to when the bilateral sensory block level reached the T6 dermatome. secondary outcomes were number of patients with cranial sensory block toT6 Level, number of patients with a modified bromage score reaching 3 at 15 min, intraoperative IV analgesia, local anesthetic volume, incidence of vasopressor administration and maternal &fetal complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Healthy pregnant women (ASAI&II) with singleton vertex presentation cephalic presentation foetus at 38 to 42 weeksꞌ gestation.
  • •Age: 20-35 years old.
  • •Weight: 57-85 Kg.
  • •Height: 155-170cm.

排除标准

  • •Non-elective CS.
  • •Known foetal anomalies.
  • •Patient refusal or uncooperative patients.
  • •Patients with history of drug abuse and maternal diseases (i.e. diabetes mellitus, cardiac disease, heart block/dysrhythmia, hypertension, chronic obstructive respiratory disease, preeclampsia, eclampsia, placenta previa, placental abruption, coagulation abnormalities or hematological diseases).
  • •Spinal deformities, previous spinal surgeries, allergy to amide type of local anesthetics, localized skin sepsis at spinal lumbar region, neurological diseases, peripheral neuropathy, neuromuscular diseases, psychiatric diseases, hepatic and renal diseases, metabolic and endocrinal diseases and Raynaud's disease.
  • •Severe hypovolemia, severe hemodynamic instability and patients with anemia (Hb <10 gm %).
  • •Morbidly obese (BMI > 35 kg/m2) patients.
  • •Those who are very short (<150cm) or very tall (>170 cm).
  • •Patients on therapy with adrenergic receptor antagonist, anticoagulants, calcium channel blocker, and/or ACE inhibitor.

研究组 & 干预措施

Dural Puncture Epidural technique using pencil-point 25G Whitacre needle

Active Comparator

干预措施: Dural Puncture Epidural technique using pencil-point 27G Whitacre needle (Procedure)

Dural Puncture Epidural technique using 27 G Whitacre needle

Experimental

干预措施: Dural Puncture Epidural technique using pencil-point 25G Whitacre needle (Procedure)

结局指标

主要结局

was the onset time to surgical anesthesia

时间窗: up to 20 minutes after local anesthetic injection

was defined as the time from the end of the intraoperative epidural test dose injection \[the start of epidural extension anaesthesia (time zero on the stopwatch)\] to when the sensory block level reached the T6 dermatome bilaterally (when the patient could no longer feel sharp sensation at T6) (assessed bilaterally at the midclavicular line)

次要结局

未报告次要终点

研究者

发起方
Reham Ali Abdelhaleem Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Reham Ali Abdelhaleem Abdelrahman

Anesthesia lecturer M.D.

Cairo University

研究点 (1)

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