An Investigation of the Influence of Different Intrathecal Opioids on the Post-operative Pain Experiences of Woman at Rahima Moosa Mother and Child Hospital
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Opioid Analgesic Requirements measured by total morphine usage on Patient Controlled Analgesic pump
研究概览
简要总结
This is an interventional drug trail to evaluate the effect of different intrathecal opioids on post-operative pain experiences in women who have undergone caesarean section surgery.
详细描述
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To evaluate the effect of three different intrathecal opioid mixtures on post-operative pain experiences in women who have undergone caesarean section surgery, relating specifically to:
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Post-operative analgesic requirements at two time points (12 hours and 24 hours) after surgery
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Pain scores at two time points (12 hours and 24 hours) after surgery
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Sedation scores at two time points (12 hours and 24 hours) after surgery
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Post-operative nausea scores at two time points (12 hours and 24 hours) after surgery
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Post-operative pruritis scores at two time points (12 hours and 24 hours) after surgery
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To determine the impact that the patients' post-operative pain has on their activities in the first 24 hours after surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients > 18years having caesarean section surgery under single shot spinal neuraxial anaesthesia at Rahima Moosa Mother and Child Hospital
排除标准
- •Pre-operative:
- •b) Patient refusal or inability to give informed consent c) Severe pre-eclampsia d) Eclampsia e) Patient unable to understand how to use the Patient Controlled Analgesia (PCA) pump, after appropriate counselling and training
- •Intra-operative:
- •a) Obstetric Complications: i) Post-partum Haemorrhage ii) Ruptured Uterus iii) Still Birth b) Conversion to general anaesthesia intra-operatively c) Administration of supplementary intravenous opioid analgesics
- •Post-operative:
- •Patients who have babies that require additional care, for a prolonged period, after birth eg. Neonatal ICU admission for ≥ 12hours or congenital abnormalities
- •Patients who require ICU or High care admission postoperatively for any intra-operative complications
研究组 & 干预措施
Morphine100
1.8ml 0.5% hyperbaric bupivacaine with 0.1mg preservative-free morphine (mixed in 0.4ml normal saline to a volume of 2.3ml) administered into the intrathecal space
干预措施: Morphine100 (Drug)
Morphine100
1.8ml 0.5% hyperbaric bupivacaine with 0.1mg preservative-free morphine (mixed in 0.4ml normal saline to a volume of 2.3ml) administered into the intrathecal space
干预措施: Hyperbaric Bupivicaine (Drug)
Morphine100
1.8ml 0.5% hyperbaric bupivacaine with 0.1mg preservative-free morphine (mixed in 0.4ml normal saline to a volume of 2.3ml) administered into the intrathecal space
干预措施: Indomethacin (Drug)
Morphine50
1.8ml 0.5% hyperbaric bupivacaine with 0.05mg preservative-free morphine (mixed in 0.4ml normal saline to a volume of 2.3ml) administered into the intrathecal space
干预措施: Morphine50 (Drug)
Morphine50
1.8ml 0.5% hyperbaric bupivacaine with 0.05mg preservative-free morphine (mixed in 0.4ml normal saline to a volume of 2.3ml) administered into the intrathecal space
干预措施: Hyperbaric Bupivicaine (Drug)
Morphine50
1.8ml 0.5% hyperbaric bupivacaine with 0.05mg preservative-free morphine (mixed in 0.4ml normal saline to a volume of 2.3ml) administered into the intrathecal space
干预措施: Indomethacin (Drug)
Fentanyl25
1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space
干预措施: Fentanyl (Drug)
Fentanyl25
1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space
干预措施: Hyperbaric Bupivicaine (Drug)
Fentanyl25
1.8ml 0.5% hyperbaric bupivacaine with 25μg fentanyl (2.3ml volume) administered into the intrathecal space
干预措施: Indomethacin (Drug)
结局指标
主要结局
Opioid Analgesic Requirements measured by total morphine usage on Patient Controlled Analgesic pump
时间窗: For 24 hours after surgery
The total administered morphine dose administered to the patient through the PCA pump will be documented. This is documented at 24 hours after surgery.
Patient Pain Score measured by the Numeric Pain Rating scale
时间窗: 24 hours after surgery
The instrument consists of 11 numbered points ( 0 to 10) each of which represent a different pain level for the patient. The scale ranges from 0=NO PAIN up to 10= worst pain possible. This is assessed at 24 hours after surgery.
Patient sedation scores measured by a 4 point sedation scale
时间窗: 24 hours
The instrument consists of 4 numbered points ( 0 to 3) each of which represent a different level of sedation for the patient. The scale ranges as follows: 0 =awake, 1 = mild drowsiness, 2 = moderate drowsiness, easily awaken, 3 =difficult to arouse.This is assessed at 24 hours after surgery.
Patient post-operative nausea and vomiting score using a 4 point scale
时间窗: 24 hours
The instrument consists of 4 numbered points ( 0 to 3) each of which represent a different level of nausea for the patient. The scale ranges as follows: 0 = No Nausea, 1 = presence of nausea without vomiting, 2 = mild to moderate vomiting (not requiring treatment), 3 = severe vomiting (treatment required). This is assessed at 24 hours after surgery.
Patient post-operative pruritis Score using a 2 point scale
时间窗: 24 hours
The instrument consists of 3 numbered points ( 0 to 2) each of which represent a different level of pruritus for the patient. The scale ranges as follows: 0 = no pruritus, 1 = mild to moderate pruritus (not requiring treatment), 2 = severe pruritus (treatment required). This is assessed at 24 hours after surgery.
Patient respiratory rate measured by counting the respiratory rate over a one minute period
时间窗: 24 hours
The patients respiratory rate will be counted by the investigator at the time of evaluation at 24hours after surgery. The resulted will be documented as a rate per minute.
次要结局
- The Impact of the patients pain on their activity measured using an 11 point scale(24 hours)
研究者
Sean Chetty
Senior Clinical Lecturer
University of Witwatersrand, South Africa