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临床试验/NCT06346860
NCT06346860已完成不适用

Comparing Postoperative Analgesic Effects of Intrathecal Morphine With Modified Thoracoabdominal Nerve Block Through Perichondral Approach in Major Abdominal Surgery

Marmara University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年4月15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
56
试验地点
1
主要终点
Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device

研究概览

简要总结

Abdominal surgery causes severe postoperative pain due to retraction of the abdominal wall and direct manipulation of visceral organs. It leads to delayed postoperative recovery, increased postoperative morbidity and mortality. Intrathecal morphine, epidural analgesia and patient-controlled intravenous analgesia are used in postoperative pain management of abdominal surgeries. Intrathecal morphine is frequently used in many centers because it provides effective pain control. However; morphine has undesirable effects such as urinary retention, postoperative nausea and vomiting, and respiratory depression. Modified thoracoabdominal nerves block through perichondrial approach is a technique defined by the modification of the thoracoabdominal nerves block through perichondrial approach, in which local anesthetics are delivered only to the underside of the perichondral surface. The primary implication of this study is to compare postoperative pain scores and opioid consumption in patients undergoing major abdominal surgery with intrathecal morphine or modified thoracoabdominal nerves block through perichondrial approach.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years old
  • Patients undergoing major abdominal surgery

排除标准

  • Patients with solid organ dysfunction
  • Patients who receive opioid or corticosteroid medication prior to surgery
  • Patients with bleeding diathesis
  • Patients with psychiatric disorders
  • Patients who can not be contacted after surgery

研究组 & 干预措施

Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and PCA

Active Comparator

Modified Thoracoabdominal Nerve BlockThrough Perichondral Approach and Intravenous Patient Controlled Analgesia

干预措施: Regional Block Comparison (Procedure)

Intrathecal Morphine and Intravenous Patient Controlled Analgesia

Placebo Comparator

Intrathecal Morphine 200 mcg and Intravenous Patient Controlled Analgesia (1 mg/ml morphine, 1 cc bolus, 7 min. locked

干预措施: Regional Block Comparison (Procedure)

结局指标

主要结局

Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device

时间窗: 48 hours

Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous morphine consumption will be recorded via PCA device, then it will be documented in mg/kg units.

次要结局

  • Postoperative pain assessment with Numeric Rating Scale (NRS)(48 hours)
  • Comparison of the frequency of treatment related complications(48 hours)
  • Participant satisfaction(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beliz Bilgili

Associate Professor

Marmara University

研究点 (1)

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