Randomized Controlled Trail Comparing Ropivacaine 0.125% and Ropivacaine 0.2% in Conjunction With Fentanyl For Continuous Epidural Infusion In Antenatal Patients Experiencing Active Labor: An Assessment of Labor Pain Management.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pain Relief Efficacy: The primary outcome will assess the effectiveness of the analgesic regimens by comparing the degree of pain relief achieved by labouring mothers in Group A (Ropivacaine 0.125% with Fentanyl) and Group B (Ropivacaine 0.2% with Fentanyl). Pain relief will be evaluated using a visual analogue scale (VAS) or other standardized pain assessment tools.
研究概览
简要总结
Labour pain is one of the most painful experience for a woman. Evidence is suggestive that disorders including maternal hypertension, dystocia, meconium staining, and foetal distress are stress related.
Of all the available methods of analgesia, epidural analgesia satisfies the basic requirements of analgesia by fulfilling the objective of decreasing the pains without affecting other sensations such as a desire to push and to allow normal walking while preserving the tone of pelvic floor muscles. This EA technique has been commonly named as “walking epiduralâ€.
Ropivacaine, a well-established local anaesthetic agent, has gained recognition for its favourable safety profile, particularly in comparison to its counterpart, bupivacaine. Its use in epidural analgesia, either as a standalone agent or in combination with adjuvants like fentanyl, has become a standard practice in obstetric anaesthesia.
There are only few studies comparing between 0.125% ropivacaine and 0.2% ropivacaine for labour pain management. We hypothesise that 0.125% ropivacaine is equally effective analgesic as 0.2% ropivacaine for labour pain with less of motor block and other associated side effects. This study will be conducted over a period of 18 months after the approval of Institutional Ethics Committee, with calculated sample size of 32 in total. With due inclusion and exclusion criteria set. Patients will be divided in two groups by computer generated double blinded block randomization technique.
GROUP A: This group will receive the 12 ml (7)of Ropivacaine 0.125% with 2μg/ml fentanyl. GROUP B: This group will receive 12 ml of Ropivacaine 0.2% with 2 μg/ml fentanyl.
Pain scores (VAS), sensory and motor block characteristics, and vital parameters (pulse, mean arterial pressure, respiratory rate) will be documented at 0 (before epidural), 5, 15 minutes, and then every 10 minutes until 1 hour, followed by assessments every 60 minutes until delivery. Throughout the study, fetal heart rate will be continuously monitored using a cardiotocograph (CTG). Further assessment will include evaluating the Apgar score at 1 and 5 minutes.
This study informs personalized pain management, enhances safety and maternal satisfaction, and influences healthcare policy. It advances evidence-based obstetric anaesthesia practices, contributing to a more patient-centered approach in, potentially improving the childbirth experience for mothers, and informing future research and clinical guidelines
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •Singleton pregnancy at term (≥37 weeks of gestation) with vertex presentation.
- •Maternal age should be between 19 and 35 years.
- •Because according to child marriage act the age of marriage for girls is 18 years and age ≥35 years is very advanced maternal age with complicated outcomes like stillbirth, preterm birth, perinatal death, GDM, gestational hypertension and preeclampsia.
- •Informed consent provided by the participant.
- •Desire for epidural analgesia for pain management.
- •Ability to understand and comply with the study procedures.
排除标准
- •Refusal to provide informed consent.
- •Twin pregnancy.
- •Breech presentation.
- •Pregnancy with antepartum haemorrhage.
- •History of adverse reactions to local anaesthetics or opioids.
- •6.Medical contraindications to epidural analgesia like increased intracranial pressure, local infection at the site of puncture, haemorrhagic diathesis or therapeutic anticoagulants.
- •Known foetal anomalies or distress necessitating immediate delivery.
- •History of drug abuse.
- •Bleeding disorders.
- •Decreased platelet counts.
- •Spinal column deformities.
- •History of spine surgery.
结局指标
主要结局
Pain Relief Efficacy: The primary outcome will assess the effectiveness of the analgesic regimens by comparing the degree of pain relief achieved by labouring mothers in Group A (Ropivacaine 0.125% with Fentanyl) and Group B (Ropivacaine 0.2% with Fentanyl). Pain relief will be evaluated using a visual analogue scale (VAS) or other standardized pain assessment tools.
时间窗: 24 months
次要结局
- 1. Analgesic Consumption: The total amount of analgesic agents used by participants in each group will be recorded, including the volume of ropivacaine and the amount of fentanyl administered.(2. Onset and Duration of Pain Relief: The time taken for pain relief to begin (onset) and the duration of effective pain relief for each analgesic regimen will be documented.)
研究者
Priti Mourya
All India Institute of Medical Sciences, Nagpur
