Efficacy of intravenous dexamethasone as an adjuvant to 0.1% ropivacaine for labour analgesia using dural puncture epidural technique- A randomised double blinded trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Compare the duration of analgesia between control and study group.
研究概览
简要总结
This study involves recruiting primigravida patients through continuous sampling for safe confinement. After pre-anesthetic evaluation, eligible patients will be randomized into two groups (Group D and Group R). Group D receives IV Dexamethasone, while Group R receives a placebo. Patient is shifted to operating room and base line vitals noted. Dural puncture epidural is place at level of L2L3 OR L3L4 space. Epidural analgesia is administered using 0.1% ropivacaine 12ml , and its adequacy is assessed. If analgesia is inadequate, a repeat dose same drug is given.
Quality of analgesia is evaluated by visual analogue score, verbal scoring system and motor blockade is assessed using a Modified Bromage score.
Patients with no motor blockade are given a supervised trial walk. Analgesia duration is noted, and top-ups are given as needed if the patient VAS score is >3 during contractions.
Monitoring includes hemodynamic parameters for the mother and fetal heart rate at 15-minute intervals. The study aims to evaluate the effectiveness of Dexamethasone in labor analgesia.
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 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primi with singleton pregnancy ASA 2.
排除标准
- •1.Expectant mothers who have recently received parenteral opioid 2.systemic and local sepsis 3.abnormal coagulation profiles,
- •multiple pregnancies
- •non cephalic presentations, allergies to study drugs like ropivacaine and dexamethasone, 6.history of peptic ulcer disease uncontrolled diabetes.
结局指标
主要结局
Compare the duration of analgesia between control and study group.
时间窗: Time from patient having good pain relief after administration of the drug till patient complaining of moderate to severe pain.
次要结局
- To compare Heart rate & mean arterial pressure between control & study group.(At 10 minutes intervals from the time of administration of epidural to the time of baby delivery.)
研究者
C Gokula varshini
Mahatma Gandhi medic college and research institute