Comparison of Three Different Doses of Intrathecal Morphine for Analgesia After Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Fentanyl consumption in the first 24 hours after surgery
研究概览
简要总结
In our study, It was aimed to determine the dose of morphine that provides the most effective analgesia with the least incidence of side effects in the postoperative period.
详细描述
Spinal anesthesia is a widely used method in cesarean section operations. It has become a popular practice to add opioids to local anesthetic agents to improve the quality and prolong the duration of intraoperative and postoperative analgesia. Morphine and fentanyl are commonly used opioids for this purpose. In cesarean sections, intrathecal morphine (ITM) is preferred for postoperative analgesia due to its slow onset and long-term analgesia, and intrathecal fentanyl is preferred for intraoperative analgesia due to its faster onset of action.
ITM can cause side effects such as nausea, vomiting, itching, sedation and respiratory depression. The quality of analgesia and the incidence of side effects may vary depending on the ITM dose used. There are studies indicating that reducing the dose of ITM results in good quality, long-term analgesia with a low incidence of side effects. However, the ideal dose of ITM providing optimal postoperative analgesia with the lowest incidence of side effects for cesarean section has not been determined yet in the literature. For this purpose, in this study it was compared the postoperative analgesia efficiency and incidence of side effects of three different ITM doses in order to contribute to the literature.
Patients were divided into three groups:
Group 1: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine was administered.
Group 2: 10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine was administered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The patients were randomly divided into three groups of 50patients each. In the system where computer generated random numbers (SPSS v23.0, IBM,- Page 2 of 6 [DRAFT] -NewYork, USA) were used, groups were determined at a ratio of 1:1:1 . Sealed and sequentially numbered envelopes were created. One hour before the operation, an experienced anesthesiologist, who was not involved in the intraoperative and postoperative follow-up of the patient and would only perform the spinal anesthesia procedure, opened a sealed opaque sealed envelope to learn the group that the patient would be included in. There were two different physicians who performed intraoperative and postoperative follow-up. Both of the follow-up physicians were blind to the patient group
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing cesarean section
- •Between the ages of 18-40,
- •Pregnant women with gestational week > 36
排除标准
- •Not accepting regional anesthesia,
- •İnfection at the injection site,
- •Coagulopathy, bleeding diathesis,
- •Severe hypovolemia,
- •İncrease in intracranial pressure,
- •Pregnant women with problems such as severe aortic stenosis, severe mitral stenosis for which spinal anesthesia is contraindicated,
- •Patients with a history of allergy to any drug included in the study protocol
研究组 & 干预措施
Group 1
Group 1: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 80 mcg intrathecal morphine) + iv Fentanyl-PCA
干预措施: 80 mcg intrathecal morphine (Drug)
Group 2
Group 2: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 120 mcg intrathecal morphine) + iv Fentanyl-PCA
干预措施: 120 mcg intrathecal morphine (Drug)
Group 3
Group 3: Spinal Anesthesia (10 mg hyperbaric bupivacaine + 20 mcg fentanyl+ 160 mcg intrathecal morphine) + iv Fentanyl-PCA
干预措施: 160 mcg intrathecal morphine (Drug)
结局指标
主要结局
Fentanyl consumption in the first 24 hours after surgery
时间窗: Postoperative Day 2
Fentanyl consumption in the first 24 hours was measured. Patients were able to request opioids via a PCA device when their VAS score is above 4 at rest and during activity (coughing and walking).
次要结局
- The incidences of post-operative nausea and vomiting (PONV)(Postoperative Day 2)
- The incidence of side effects related to opioid use(Postoperative Day 2)
- Post-operative acute pain(Postoperative Day 2)
- APGAR score(The 5th minute APGAR score was recorded.)
- Bromage Score Comparison(Postoperative 2nd hour.)
研究者
Ilke Tamdogan
Physician
Ondokuz Mayıs University