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临床试验/NCT05698927
NCT05698927已完成不适用

Can Erector Spinae Plane Block Replace Intrathecal Morphine in Cesarean Section? a Prospective Randomized Controlled Study on Opioid Consumption

Marmara University2 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
2
主要终点
Opioid Consumption

研究概览

简要总结

Cesarean section cause severe pain due to surgical incision, abdominal wall retraction and visceral organ movements. Cesarean section can be performed with general anesthesia, spinal anesthesia, epidural anesthesia and combined spinal epidural anesthesia methods.

Because of the possibility of aspiration pneumonia in pregnant women are under general anesthesia, the awareness of anesthesia in the mother during the operation due to insufficient anesthesia, unsuccessful intubation, respiratory complications in the mother and newborn and low APGAR scores, regional anesthesia is superior to general anesthesia in elective cesarean section operations.

Spinal anesthesia, abdominal wall blocks such as erector spinae plane block, parenteral and intrathecal opioids may be used for postoperative analgesia in cesarean section operations.

Intrathecal morphine can cause postoperative nausea-vomiting, itching, respiratory depression. Erector spina plane block can provide effective pain control and reduce opioid consumption.

The primary implication of this study is to compare postoperative pain scores and opioid consumption on elective cesarean section patients under spinal anesthesia with intrathecal morphine or erector spina block in addition to spinal anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients between 18 and 40 years old, ASA (American Society of Anesthesiologists) score I-II, undergoing elective cesarean section

排除标准

  • •Emergency cesarean section
  • •The patients with major hepatic, cardiovascular or renal disease
  • •The patients for whom spinal anesthesia is contraindicated
  • •The patients who is allergic to any drugs that we use for this study
  • •Patients who declined to participate in the study

研究组 & 干预措施

Intrathecal Morphine Group

Active Comparator

Bilateral Erector Spinae Plane Block (with %0.25 bupivacaine, 20 ml for each side) and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 20 minutes)

Comparing postoperative pain and opioid consumption in groups

干预措施: Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg) (Procedure)

Bilateral Erector Spinae Plane Block Group

Active Comparator

Intrathecal morphine (100mcg) and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 20 minutes) Comparing postoperative pain and opioid consumption in groups

干预措施: Erector Spinae Plane Block (bilaterally, via 20ml % 0.25 bupivacain) and Intrathecal Morphine (100 mcg) (Procedure)

结局指标

主要结局

Opioid Consumption

时间窗: 24 hours

Comparing opioid (tramadol) consumption via intravenous Patient Controlled Analgesia (PCA) device

次要结局

  • Pain Scores(24 hours)
  • Side effects of medications(24 hours)
  • Rescue analgesia(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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