Comparison of analgesic efficacy of ropivacaine and levobupivacaine in labor analgesia by dural puncture epidural technique- A prospective double-blinded randomized trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time of onset to NPRS score ≤ 1
研究概览
简要总结
Randomization of included study subjects into two groups( Group R and Group L)
The DPE will be performed by following steps under aseptic precautions; patient in sitting position, identify L2-L3/L3-L4 intervertebral space, inject lignocaine 2% for local infiltration. Then 16-G Tuohy needle will be inserted in intervertebral space and identify epidural space by loss of resistance to saline technique. 26-G Whitacre spinal needle inserted through epidural needle and create dural hole. The creation of dural hole will be confirmed by free-flow of CSF. The spinal needle will be withdrawn without giving any drug in the subarachnoid space. 18-G Epidural catheter will be inserted in the epidural space. The drugs will be given only through the epidural catheter. Initial dosing consists of maximum of 20 ml of 0.125% ropivacaine with fentanyl 2µg/ml in group R and maximum of 20ml of 0.125% levobupivacaine with fentanyl 2µg/ml in group L. In both groups it will be fractionated into four 5 ml boluses given over 5 minutes. After initial dosing PCEA will be started.
A blinded anaesthesiologist will come after initial bolus dose and assess outcomes. The entry of blinded anaesthesiologist will be designated as time 0(t=0).
The outcomes will be assessed at t=0.5,2,4,6,8,10,12,14,16,18,20 and 30 minutes, then every 90 minutes until delivery.
The following outcomes will be assessed
1. Analgesia by NPRS score
2. Sensory blockade
3. Motor blockade by modified Bromage scale
4. Asymmetric blockade
5. Maternal hypotension
6. Fetal bradycardia
7. Abnormal uterine contractions
We hypothesized that ropivacaine would produce better analgesia and lower motor blockade than levobupivacaine
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA I and ASA II parturient having single fetus in vertex presentation
- •Patients in active labor with cervical dilatation <5.0 cm
- •Patients desiring labor analgesia.
排除标准
- •Patients refusal to participate
- •Patients with diseases of pregnancy such as gestational hypertension, preeclampsia, gestational diabetes mellitus
- •Patients in whom neuraxial procedures are contraindicated
- •Patients having fetus with anomalies
- •Patients who are at high chance for cesarean delivery such as cephalopelvic disproportion, previous cesarean section.
结局指标
主要结局
Time of onset to NPRS score ≤ 1
时间窗: 0.5,2,4,6,8,10,12,14,16,18,20 and 30 minutes, then every 90 minutes until delivery
次要结局
- 1. Symmetry of blockade(2. Maternal adverse effects such as pruritus, hypotension, uterine tachysystole and hypertonus)