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临床试验/NCT06397300
NCT06397300已完成不适用

Comparison of Ultrasound Guided Bilateral Erector Spinae Plane Block, Ultrasound Guided Bilateral Quadratus Lumborum Block and Lumbar Epidural for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy ; a Prospective Randomized Clinical Trial

National Cancer Institute, Egypt3 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
3
主要终点
Total postoperative opioid consumption

研究概览

简要总结

The investigators hypothesize that US Bilateral Erector Spinae Plane Block, US Bilateral Quadratus Lumborum Block and Lumbar Epidural for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy resulting in reducing myofascial pain and opioid consumption.

详细描述

Background and Rationale:

Gynecological cancers comprise 10-15% of women's cancers, mainly affecting women post-reproductive age but posing threats to fertility for younger patients.

The goal of postoperative pain control is to reduce the negative consequences associated with acute postsurgical pain and help the patient make a smooth transition back to normal function. Traditionally, opioid analgesic therapy has served as the mainstay of treatment for acute postoperative pain. However, the recent rise in morbidity and mortality associated with opioid misuse has led to increasing demands for more investigative efforts into developing pain treatment strategies that place more emphasis on using a multimodal approach. These efforts have proved to be challenging, as the subjective nature of pain perception further complicates the ability to achieve satisfactory pain control. Furthermore, specific patient comorbidities and social factors may predispose patients to have increased pain perception.

Approximately 75 percent of patients who undergo surgery experience acute postoperative pain, which is often medium-high in severity. Less than half of patients undergoing surgery report adequate postoperative pain relief. This percentage presents a significant problem as inadequate postoperative pain control may lead to adverse physiologic effects among patients in the immediate postoperative period and place them at increased risk of developing chronic pain associated with the procedure. Severe persistent postoperative pain affects 2 to 10 percent of adults.

Multiple peer-reviewed publications address the topic of postoperative pain control in gynecologic oncology surgery. Because many of these surgeries require large laparotomy incisions, patients frequently receive intravenous opioids for pain control. Patient-controlled analgesia, or PCAs, are often used as the mechanism of delivery as they allow patients to deliver pain medications based on their perceived needs. Intravenous opioids are associated with undesired side effects, including nausea, pruritus, hallucinations, and delay in the return of bowel function, which may ultimately lead to prolonged hospitalization and extended recovery times. The use of ultrasonographic technology in regional anesthesia practice has not only eased the application of nerve blocks and interfascial blocks but also led to the definition and practical use of many new interfascial blocks. Thoracoabdominal/thoracolumbar blocks - also named as truncal blocks, have gained popularity recently with the number of such defined blocks increasing substantially.

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, Investigator)

盲法说明

The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 30 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA class II , III and IV
  • 18yrs ≥ Age ≤ 65yrs
  • Body mass index (BMI): 20-40 kg/m2
  • Patient undergoing total abdominal hysterectomy under general anesthesia.

排除标准

  • Age < 18yrs or > 65yrs
  • Patient refusal
  • known sensitivity or contraindication to drugs used in the study
  • Contraindication to regional anesthesia e.g. local sepsis or coagulopathy
  • History of psychological disorders and chronic pain

结局指标

主要结局

Total postoperative opioid consumption

时间窗: first 24 hours postoperatively

Total postoperative morphine consumption till the first 24 hours postoperatively

次要结局

  • Postoperative nausea and vomiting(24 hours Postoperative)
  • Total intraoperative fentanyl consumption(intraoperative)
  • Ramsay scores(at 0, 4, 8, 12, and 24 postoperatively.)
  • Visual analogue scale VAS(0, 4, 8, 12 and 24 postoperatively.)
  • mean arterial blood pressure.(intraoperative and 0, 4, 8, 12 and 24 postoperatively.)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohamed Soliman

lecturer of anesthesia

National Cancer Institute, Egypt

研究点 (3)

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