跳至主要内容
临床试验/CTRI/2023/11/060359
CTRI/2023/11/060359招募中4 期

Comparison of analgesic efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) with Parenteral Tramadol for Labour Analgesia: a multi-center, randomized, double blind, placebo-controlled superiority trial

Sri Madhusudan Sai Institute of Medical Sciences and Research1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2023年12月11日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
340
试验地点
1
主要终点
Mean Numerical Rating Scale (NRS) Pain score (0-10) taken at the baseline and every hour post intervention till delivery of placenta

研究概览

简要总结

Labour pain is considered to be one of the worst pains experienced. Labour analgesia should be offered to every women who demands pain relief.. However, pain relief options for Indian women are suboptimal.. In India, the practice of labour analgesia shows wide variability and in some centres, is non-existent.. Epidural analgesia (EA) is the gold standard for pain relief during childbirth.. In the developed world, 60% of women receive. In India, less than 10% of women are offered EA.. Setting up an EA service may be not feasible due to the significant cost and expertise required. Although EA provides excellent pain relief, it is not without adverse effects as well as potentially serious complications.. EA can prolong labour and increase the risk of assisted vaginal delivery.. In the rural sector, tramadol forms the mainstay, despite limited efficacy in labour. Ultrasound guided erector spinae plane block (ESPB) is a recently described technique. ESPB provides analgesia by targeting the paravertebral nerves. A few anecdotal reports suggest a role in labour analgesia .. The advantages compared to EA include technical simplicity and a favourable safety profile. The location of the ESPB away from the neural axis mitigates potentially serious complications associated with EA. ESPB is versatile and can provide widespread analgesia covering thoraco-lumbo-sacral dermatomes. Literature also suggests that the ESP block confers analgesic characteristics without motor block or haemodynamic disturbance. ESPB can be performed in coagulopathic states often seen in pregnancy. In addition, unlike EA, a single shot bilateral ESPB injection could be sufficient to provide pain relief covering the entire childbirth. These attributes make ESPB a candidate for providing cost-effective and safe and labour analgesia. We performed a service evaluation of ESPB analgesia in labour at our center. The evaluation was mandated due to poor efficacy of the standard management. In addition, there was an increase in maternal demand for caesarean section due to poorly controlled labour pain. We observed that ESPB provides adequate analgesia with high maternal satisfaction. In addition, we observed a trend of augmentation of active stage I and Stage II labour probably due to the addition of dexamethasone in ESPB. The current evidence for ESPB in Labour is limited to a few cases. We would like to formally assess the efficacy of ESPB analgesia in labour when compared to standard treatment (parenteral tramadol).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • Primigravida women in labour scheduled for normal vaginal delivery with Singleton pregnancy, Cephalic presentation and >36 week gestation who are willing to consent.

排除标准

  • Participants unwilling to provide consent
  • High risk pregnancy (Gestational Diabetes Mellitus [GDM], Pre-Ecclampsic toxemia [PET]
  • Cephalo-pelvic disproportion (CPD)
  • Multiparity
  • Participants with known history of drug allergy to bupivacaine or dexamethasone.

结局指标

主要结局

Mean Numerical Rating Scale (NRS) Pain score (0-10) taken at the baseline and every hour post intervention till delivery of placenta

时间窗: Baseline | 1 Hour, 2 hours, 3 hours, 4 hours, 5 hours post intervention till delivery of placenta

次要结局

  • Patient satisfaction with pain relief(after delivery of the placenta)
  • Duration of Active stage I labour(cervical dilatation of 4 cm to 10 cm)
  • Maternal outcomes(from recruitment till delivery of placenta)
  • Fetal outcomes(5 minutes to 1 hour after delivery)

研究者

发起方
Sri Madhusudan Sai Institute of Medical Sciences and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Niraj Gopinath

Sri Madhusudan Sai Institute of Medical Sciences and Research

研究点 (1)

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