Prospective observational study to assess the duration of postoperative analgesia in patients undergoing elective lower segment caesarean section under spinal anesthesia with Morphine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Duration of analgesia post intrathecal Morphine as indicated by duration to first patient requested analgesia is the primary outcome.
研究概览
简要总结
Moderate to severe postoperative pain is experienced by women undergoing lower-segment caesarean section. Intrathecal Morphine is proposed as the gold standard for postoperative pain relief in patients undergoing LSCS. It is a part of multimodal analgesia in the Enhanced Recovery After Surgery (ERAS) pathway. The duration of analgesia provided varies between 20 and 48 hours in different populations, with an average of 9.4 hours. This study primarily aims to determine the duration to the first analgesia requirement after LSCS when spinal anesthesia is provided with intrathecal Morphine. Pain score, as described by the Visual Analog Scale, at which the patient requested additional analgesia, will also be recorded.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA physical status 2 singleton pregnant mothers over 145 cm in height with no comorbidities or well-controlled comorbidities with normal placentation, undergoing elective lower segment caesarean section at full term.
排除标准
- •Mothers with high-risk pregnancy, multiple pregnancy, or uncontrolled comorbidities.
- •Mothers who undergo lower segment caesarean section under general anesthesia, or those who have failed spinal anesthesia.
- •Mothers who have chronic pain syndrome, allergy to opioids, fetal or placental anomalies.
- •Mothers undergoing preterm or post-term caesarean delivery.
- •Mothers who have postpartum hemorrhage and those who received additives other than morphine 100mcg.
结局指标
主要结局
Duration of analgesia post intrathecal Morphine as indicated by duration to first patient requested analgesia is the primary outcome.
时间窗: Duration of analgesia post intrathecal Morphine as indicated by duration to first patient requested analgesia is the primary outcome.
次要结局
- Incidence of respiratory depression defined as respiratory rate less than 10(immediate post operative period)
- Incidence of sedation as described by RASS sedation scale(Immediate post operative period)
- Incidence of post operative nausea and vomiting(48 hours post operatively)
- Incidence of post operative pruritus(48 hours after intrathecal morphine administration)
- Duration to flatus(Time from intrathecal morphine administration to passing flatus first)
研究者
SamCharles
Christian Medical College, Vellore