Comparison of General Anesthesia and Combined Spinal-epidural Anesthesia on Postoperative Outcomes in Patients Undergoing Transabdominal Cervico Isthmic Cerclage (TCIC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain score at 24hours after the end of the operation
研究概览
简要总结
The investigator aimed to compare the effect of anesthesia on overall postoperative outcomes including post-operative pain score and the fetal well-being (heart rate) in patients undergoing transabdominal cervico isthmic cerclage(TCIC). The investigator divided the patients into two groups. The first group was the patients who undergo general anesthesia with postoperative wound patient-controlled analgesia device(PCA) and the second group was the patients who undergo combined spinal-epidural anesthesia(CSE) with postoperative epidural catheter PCA device for pain control.
详细描述
Transabdominal cervico isthmic cerclage(TCIC) is performed for the pregnants with Incompetent Internal Os of the Cervix(IIOC) to maintain pregnancy. It is the operation that incise the lower abdomen and ligate the cervix in pelvic cavity. In our center, the surgery was conventionally performed under general anesthesia. Also, for pain control, operator has been inserting a catheter into the incision site and connected the wound PCA. In this way, there were some limitations that the wound PCA could only control the somatic pain and there were significant rates of post-operative nausea and vomiting as common complication of general anesthesia. Thus, the investigator planned to conduct combined spinal-epidural anesthesia(CSE) with postoperative pain control with epidural catheter and compare overall postoperative outcomes with conventional general anesthesia.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who undergo TCIC for IIOC and agree to participate in this study.
排除标准
- •Hepatic failure
- •Chronic kidney disease(>stage III)
- •Hypersensitivity, allergic response and/or resistance to drugs used in this study(ex. pethidine, ropivacaine)
- •Spinal anesthesia is not possible
- •Refuse to participate in the study
- •Cannot understand the agreement
- •Body weight is under 50 kg or over 100 kg
研究组 & 干预措施
Spinal anesthesia group
Spinal anesthesia is used for operation with epidural patient-controlled device for pain control. Bupivacaine Hcl 0.5% Inj. 9-10mg is injected into intrathecal space for anesthesia. 0.2% ropivacaine is used for postoperative pain control with continuous infusion into epidural space.
干预措施: Bupivacaine Hcl 0.5% Inj (Drug)
General anesthesia group
General anesthesia is used for operation with wound patient-controlled device for pain control. propofol (10milligram/ML) 1.5-2 mg/ml is used as bolus intravascular injection for induction of anesthesia. 0.5% ropivacaine is used for postoperative pain control with continous infusion through wound catheter.
干预措施: Propofol 10 milligram/ML (Drug)
结局指标
主要结局
Pain score at 24hours after the end of the operation
时间窗: Assessed by directly asking to the patient, from date of randomization up to postoperative day 3.
Numerical Rating Score(0-10), 0:no pain, 5:moderate pain, 10:worst pain
次要结局
- Fetal viability on postoperative day 5(Assessed by ultrasonography, upto postoperative day 5.)