跳至主要内容
临床试验/CTRI/2024/10/075255
CTRI/2024/10/075255尚未招募2/3 期

To compare the efficacy and safety of two different doses of dexmedetomidine 0.2 mcg per ml and 0.5 mcg per ml as adjuvant to ropivacaine 0.2 percent for epidural labor analgesia. A prospective randomized control trial

GOVERNMENT MEDICAL COLLEGE BHAVNAGAR1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月25日最近更新:
适应症
相关药物

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
100
试验地点
1
主要终点
• To compare the quality of pain relief using VAS (Visual Analogue Scale) score.

研究概览

简要总结

Child birth is natural, memorable yet most painful experience of the women. Throughout

pregnancy, painless Braxton Hicks contractions with simultaneous hardening of uterus occur. As

the labor progresses, these contractions change its character, become more powerful,

intermittent and are associated with pain. Pain more often felt in front of the abdomen or

radiating toward thigh.

• Ropivacaine, an amide local anesthetic which is selective for sensory fibers and preserving motor

thus produce true walking epidural, can be used successfully.

• Local anesthetic solutions in very low doses with alpha-2 agonist as an adjuvant can be used

safely to prolong effect of local anesthetic in labor analgesia.

Pain relief is fundamental right parturient. pain relief in labor has always been surrounded

with myth and misbelief.

• Amongst all, epidural analgesia remained the gold standard.

• As newer local anesthetic drug like ropivacaine will provide pain relief in labor without

affecting motor fibers thus provide true walking epidural.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • •Age 18 to 30 years
  • •Term primi gravida, cephalic singleton pregnancy
  • •Uterine contractions at least once in 5 minutes with cervical dilatation 3 to 4 cm.

排除标准

  • •Patient having history of allergy to Local anesthetic agent
  • •Patient having preterm labor, pre-eclampsia, eclampsia, thyroid disorder, cardiomyopathies, multiple pregnancy, previous LSCS, Abnormal lie, antepartum hemorrahge, morbid obesity, severe anemia, hemodynamic instability
  • •Any psychiatric or neurological disorder or altered mental status.

结局指标

主要结局

• To compare the quality of pain relief using VAS (Visual Analogue Scale) score.

时间窗: Before bolus | At 10 min of bolus | At 20 min of bolus | At 30 min of bolus | At 1 hour of bolus | At 1.5 hour of bolus | At 2 hour of bolus | At 2.5 hour of bolus | At 3 hour of bolus | At 3.5 hour of bolus | At 4 hour of bolus | Every half hourly till expulsion of placenta

次要结局

  • 1. To compare hemodynamic parameters changes(pulse, blood pressure, spo2) during labor(2. To compare duration of progression of 1)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Sagar P Kanani

Government Medical College Bhavnagar

研究点 (1)

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