跳至主要内容
临床试验/CTRI/2020/08/027060
CTRI/2020/08/027060尚未招募不适用

Comparison of dural-puncture epidural (DPE) and epidural analgesia (EA)for labor-a prospective randomized double blind study

Dr Ashok Jadon1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月14日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
2. Time taken to achieve VAS of 3

研究概览

简要总结

Epidural analgesia (EA) is the gold standard for pain relief during labor. Many new techniques have been  incorporated with EA to make it more effective like addition of various adjuvants, practice of spinal epidural technique and dural puncture epidural technique (DPE). DPE is relatively new technique where intentional dural puncture with spinal needle is done before insertion of epidural catheter while EA is being done. The proposed advantages are early onset of pain relief and better efficacy. We regularly use EA for labor analgesia. We want to compare this new approach with our standard EA technique.

Patients who are willing after informed consent for epidural analgesia for labor pain relief will be divided in two equal groups by random table. After explaining the visual analogue scale score (VAS score), with due aseptic precautions and with standard vital monitoring 18G tuohy epidural needle will be placed at L3-L4 level under local anaesthesia to locate epidural space by loss of saline. Afterwards, 27G Whitacre spinal needle will be inserted through epidural needle. In DPE group intentional dural puncture will be attempted (confirmed by CSF back -flow) while in EA group, needle will only be inserted for 1-2cm (sham puncture). After  removal of spinal needle, epidural catheter will be inserted and needle will be removed. The marking of catheter at skin will be calculated to keep catheter 3-5cm in the epidural space. After negative aspiration test, 3ml 0.125% bupivacaine will be given through catheter. After waiting for 3 minutes if no sign of spinal anaesthesia or accidental intravascular injection is noted, 9ml of same local anesthetic will be injected with repeated aspiration test over 2 minutes. Catheter will be fixed and dressed with transparent dressing. Then an infusion of 0.8% bupivacaine and fentanyl 2microgram/ml will be given by infusion pump @10ml/hr.  VAS score will be recorded every 2 minutes till it comes down to 3. Time to 50% reduction in VAS from base line value and time to achieve VAS 3 will be recorded. VAS will be monitored every hr till the delivery. Breakthrough pain will be managed by 5ml bolus of 0.125% bupivacaine every 15 minutes till VAS comes to 3. All the data about duration of labor, total dose of bupivacaine and fentanyl used, VAS scores, outcome of labor and APGAR of newborn  will be recorded and analysed by appropriate statistical tools for analysis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Who has give the consent for labor epidural analgesia.

排除标准

  • Refusal to give consent.
  • Contraindication for spinal or epidural
  • History of drug allergy to local anesthetics.
  • Severe systemic disease related to respiratory, cardiovascular, central nervous system.
  • Psychiatric disorder and migraine.

结局指标

主要结局

2. Time taken to achieve VAS of 3

时间窗: 1.Baseline | 2. Every 5minutes for 30 minutes. | 3. Every hr for 12 hr

1. Onset of analgesia eg. 50% reduction in (VAS)visual analogue score.

时间窗: 1.Baseline | 2. Every 5minutes for 30 minutes. | 3. Every hr for 12 hr

次要结局

  • 1.Out come of labor.(2.Incidence of motor block.)

研究者

发起方
Dr Ashok Jadon
申办方类型
Other [self]

研究点 (1)

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