CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens (SSS)
Combined Spinal Epidural Analgesia in Labour: A Comparison of Two Intrathecal Regimens of Single Shot Spinal
Analgesia in labour is not readily available in many parts of Sub-Saharan Africa. The overall cost of Epidural services in terms of human personnel and financial implication makes this inaccessible to many women in labour. Thus, a cheaper, less technically demanding and easier option that can produce as much satisfaction for the parturient and would allow her participate in the second stage of labour by being able to bare down is being studied.
The Single Shot Spinal (SSS) would provide pain relief in these women however its draw back is its time limitation as the option of a top up is not available.
Two regimen of drug options would be considered using opioids. These would be compared to see how well they are able to provide analgesia in women who hitherto have had vaginal birth. Their onset, duration of action and possible side effects would be compared.
NULL HYPOTHESIS: Single Shot Spinal with Bupivacaine Fentanyl (BF) cannot provide a statistically significant difference in labour analgesia in comparison with Bupivacaine Fentanyl Morphine (BFM) ALTERNATE HYPOTHESIS: Single Shot Spinal with BF can provide a statistically significant difference in labour in comparison with BFM
研究概览
详细说明
A double blinded randomized study comparing 2 intrathecal mixtures for labour analgesia.
94 multiparous parturients in active labour who have given informed consent would be recruited into the study. They would be randomly allocated into 2 groups using simple random sampling. An Assistant would know the code and prepare the intrathecal solutions.
Baseline vitals would be taken and patient's pain score noted. Due protocol would be followed and a combined spinal epidural sited but with the epidural not activated until the effect of the spinal wears off.
Routine monitoring would be done and various parameters and indices noted. Where the effect of the spinal lasts the duration of labour thus no need to activate the epidural, this would also be noted.
Data would be analysed using Statistical Package of Social Sciences (SPSS) version 20.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Lagos、尼日利亚
- Lagos Island Maternity Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Parturients in active labour >4cm dilatation
- American Society of Anesthesiologists (ASA) classification I and II
Exclusion Criteria:
- Significant co-morbidities like uncontrolled hypertension or diabetes
- Maternal hemorrhage with hypotension
- Significant bleeding/clotting disorders
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：BF
Interventions: Intrathecal administration -Bupivacaine 2.5mg (0.5ml) + Fentanyl 25mcg (0.5ml) + 1ml sterile water in one shot Ephedrine 3-5mg in aliquots in the event of hypotension Promethazine 12.5 - 25mg in the event of vomiting or significant pruritus naloxone 2mcg/kg in the event of respiratory distress
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Dosages as previously written
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有源比较器：BFM
Interventions: Intrathecal administration - Bupivacaine 2.5mg (0.5ml) + fentanyl 25mcg (0.5ml) + 0.25mg morphine (0.25ml) + 0.75ml sterile water in one shot ephedrine 3-5mg in aliquots for hypotension Promethazine 12.5 - 25mg for vomiting or significant pruritus Naloxone 2mcg/kg in the event of respiratory distress
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Dosage as previously written
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to First painless contraction (TFC)
大体时间：time zero to first painless contraction estimated 15 minutes
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This is the onset of action of the drugs.
The time duration from the initiation of the block at time zero to the point where there is significant drop in the Numerical Rating Scale (NRS) to 2 or less
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time zero to first painless contraction estimated 15 minutes
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Time to First Request for Analgesia (TFA)
大体时间：Time zero till NRS > 6 estimated 180 minutes
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This is the duration of action of the block.
Time from initiation of the block to time the pain score is up to 6 or more.
It is expected that after onset of the block (TFC) the pain would first become negligible or absent and after a period of time, it would gradually increase as the drug wears off.
If the pain becomes moderate at a NRS of 6 or the patient requests for analgesia, the time would be noted and the epidural would be activated.
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Time zero till NRS > 6 estimated 180 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Delivery before TFA or delivery after TFA
大体时间：duration of labour estimated 180 minutes
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Qualitative variable.
determines if rescue analgesia was needed (if the epidural needed to be activated) or if the spinal was adequate for the duration of labour
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duration of labour estimated 180 minutes
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Maternal Satisfaction
大体时间：up to 300 minutes
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Parturients perception of if analgesia was Adequate, Inadequate or Not Sure
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up to 300 minutes
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Side effects
大体时间：up to 180 minutes
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Presence of side effects like respiratory depression, pruritus, or vomiting
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up to 180 minutes
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合作者和调查者
调查人员
- 学习椅：Olaniyi Oladapo, MBBS,FMCA, FWACS、School of Anaesthetic Studies, Health Service Commission, Lagos State
出版物和有用的链接
一般刊物
- Minty RG, Kelly L, Minty A, Hammett DC. Single-dose intrathecal analgesia to control labour pain: is it a useful alternative to epidural analgesia? Can Fam Physician. 2007 Mar;53(3):437-42.
- Lee BB, Ngan Kee WD, Hung VY, Wong EL. Combined spinal-epidural analgesia in labour: comparison of two doses of intrathecal bupivacaine with fentanyl. Br J Anaesth. 1999 Dec;83(6):868-71. doi: 10.1093/bja/83.6.868.
- Hess PE, Vasudevan A, Snowman C, Pratt SD. Small dose bupivacaine-fentanyl spinal analgesia combined with morphine for labor. Anesth Analg. 2003 Jul;97(1):247-52, table of contents. doi: 10.1213/01.ane.0000066520.30763.b8.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SAS/17/03
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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Bupivacaine-fentanyl的临床试验
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Pakistan Navy Station Shifa Hospital完全的