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临床试验/NCT06550414
NCT06550414已完成不适用

Effect Of Use of Dexmedetomidine as an Adjuvant to Bupivacaine 0.1% in Labor Analgesia.

Services Institute of Medical Sciences, Pakistan1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2022年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
165
试验地点
1
主要终点
onset of analgesia

研究概览

简要总结

Females who have experienced normal labor for child birth have claimed it to be most difficult and distressing moments of their life due to excruciating and unbearable pain. Provision of effective and satisfactory labor analgesia to the parturient helps in achieving greater degree of well-being for both mother and child. Several medical and non-medical pain relief methods are used since ages for pain relief during childbirth.

Epidural anesthesia and intravenous opioids (pethidine) are most commonly offered to the mothers for relieving labor pain. So far, Epidural is considered gold standard in attaining maternal satisfaction for pain free deliveries. lt can be modified for individual parturient in order to achieve highest level of comfort and pain relief. To attain better and prolonged analgesia several additives have been used with local anesthetists and their effects are studied. Epidural opioids are conventionally being used as adjuvants, however associated side effects (nausea, vomiting, and pruritus) may limit their use. An alpha 2 adrenoceptor agonist, dexmedetomidine, has been effectively used and studied in labor epidurals and provided better analgesia without significant side effects. Hamed Lateef Hospital is one of the largest tertiary care private setup offering painless deliveries in Lahore.

It is need of the hour to modify and improve our clinical practice in order to achieve highest level of patient satisfaction and provision of best possible maternal and fetal outcome. This study is proposed to investigate and elaborate the effect of adding dexmedetomidine to bupivacaine in labor epidurals and to study possible side-effects associated with its use.

详细描述

Objectives of this study are to evaluate the efficacy of adding dexmedetomidine in labor epidurals with 0.1% bupivacaine in females undergoing normal vaginal delivery.

OPERATIONAT DEFINITIONS:

  1. Onset of Analgesia:

Time required to attain a VAS of less than or equal to 3 after giving loading dose 2. Duration of Analgesia. Time after loading dose till the VAS >3 or break-through pain reported by the mother. 3. Side effects:

  • Hypotension: systolic blood pressure < 100 mmHg or a decrease in mean arterial pressure (MAP) > 30% compared to the baseline
  • Bradycardia: heart rate less than 60.
  • Nausea, vomiting
  • Sedation

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

盲法说明

double blind.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients in 37 or more weeks of pregnancy,
  • having a single pregnancy with vertex presentation
  • without any significant systemic disease will be included in the study.

排除标准

  • Patients with mal-presentation
  • twin pregnancy
  • preeclampsia,
  • uncontrolled systemic comorbidities
  • diabetes, renal, hepatic, or cardiac.
  • bleeding, diathesis, body mass index (BMl) more than 35 kg/m2
  • known allergy to any of the study drugs will be excluded from the study.

研究组 & 干预措施

bupivacaine group

Placebo Comparator

group given 0.1% bupivacaine 10ml as loading dose in labor epidural.

干预措施: Bupivacain (Drug)

dexmedetomidine group

Active Comparator

group given 50 micrograms of dexmedetomidine along with 0.1% bupivacaine in labor analgesia dose.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

onset of analgesia

时间窗: Patient observed for 45 minutes after drug delivery and time required to achieve a VAS of 3 or less than 3 is noted down.

time noted for onset of analgesia in both groups

次要结局

未报告次要终点

研究者

发起方
Services Institute of Medical Sciences, Pakistan
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

dr. sana siddiq

assistant professor

Services Institute of Medical Sciences, Pakistan

研究点 (1)

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