A COMPARATIVE STUDY OF SUCCEDENT VERSUS CONTROL INTRATHECAL ADMINSTRATION OF 0.5% HEAVY BUPIVACAINE WITH OR WITHOUT MORPHINE IN SPINAL BLOCK FOR CAESAREAN SECTION
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- To compare the block characteristics among the groups.
研究概览
简要总结
This study explores the impact of different methods of intrathecal administration of bupivacaine (0.5% heavy) with or without morphine during spinal anesthesia for caesarean section. Specifically, it compares:
Premixed administration (bupivacaine + morphine in the same syringe),
Sequential administration (morphine before or after bupivacaine),
Bupivacaine alone.
The primary focus is to determine whether the sequence of drug administration affects:
Quality and duration of anesthesia, Hemodynamic stability, Postoperative pain relief, rescue analgesia, Side effect profile.
208 parturients undergoing caesarean section under spinal anesthesia, divided into 4 groups of 52 each.
Groups:
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Group I – Bupivacaine (9mg)(1.8ml) + morphine(200mcg)(0.2ml) premixed.
-
Group II – Bupivacaine(9mg)(1.8ml) first, followed by morphine(200mcg)(0.2ml) (sequential).
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Group III – Morphine (200mcg)(0.2ml)) first, followed by bupivacaine (9mg)(1.8ml) (sequential).
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Group IV – Bupivacaine(10mg)(2ml) only (control group).
All patients received standard preoperative fasting, IV access, premedication, and spinal anesthesia using 27G Quincke needle at L3-L4.
Hemodynamic parameters and block characteristics were recorded.
Pain was assessed using Visual Analogue Scale (VAS), motor block by Modified Bromage Scale, and sedation by Ramsay Sedation Score.
Postoperative monitoring included duration of analgesia, incidence of hypotension, bradycardia, respiratory depression, nausea, and any neurological complications.
The study seeks to determine the optimal technique for intrathecal drug administration to:
Prolong analgesia, enabling early ambulation and faster recovery,
Minimize complications (e.g., hypotension),
Improve postoperative outcomes, reduce hospital stay,
Provide evidence-based guidance for better obstetric anesthesia practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •208 healthy full term non labouring parturients, ASA I -II (American Society of Anaesthesiologists Physical status grading system), with singleton pregnancy scheduled for both elective and caesarean (CS) under SAB are included in the study .
排除标准
- •Complicated pregnancy
- •Multiple pregnancy
- •Pregnancy with bleeding disorders, spinal deformity, any other contraindication to SAB
- •Pregnancy with acute fetal distress
- •Intrauterine deaths or known fetal anomaly
- •Severe PIH (Pregnancy Induced Hypertension).
结局指标
主要结局
To compare the block characteristics among the groups.
时间窗: The time of sensory block height and maximal cephalad height and onset of motor block and regression time will be noted.
次要结局
- To compare the maternal hemodynamic and any intra-op and post-op complications among the groups.(vitals will be monitored every 2 min for 20 mins and every 5 mins after 20 mins until 75 mins.)
- To compare the VAS score and any additional analgesia requirement among the groups
- To compare the neonatal outcome among the groups.
研究者
Dr Jahanara
GMC haldwani