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临床试验/NCT04133051
NCT04133051已完成2 期

Perioperative Analgesic Efficiency of Ultrasound Guided Quadratus Lumborum Block Versus Epidural Analgesia in Bladder Cancer Patients Undergoing Radical Cystectomy

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2018年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
34
试验地点
1
主要终点
Visual analogue pain (VAS) score measurement 24 hours postoperatively

研究概览

简要总结

This study is performed to measure the perioperative analgesic efficiency of bilateral quadratus lumborum block versus epidural analgesia in bladder cancer patients undergoing radical cystectomy

详细描述

  1. Background and rationale:

Bladder cancer is the ninth most common cancer in the world while being considerably common in both developed and developing countries. Bladder cancer is the most common malignancy among Egyptian males and it had been previously attributed to Schistosoma infection, a major risk factor for squamous cell carcinoma (SCC). Recently, transitional cell carcinoma (TCC) incidence has been increasing while SCC has declined. Exposures to tobacco smoke, occupational toxins, and environmental sources of heavy metals such as arsenic are the major reported risk factors for TCC .

Acute perioperative pain management has been a matter of attention especially in major abdominal surgeries like radical cystectomy. Poor perioperative pain management especially with major abdominal surgeries can lead to deterioration of both physiological and psychological status of the patient leading to anxiety, stress, and patient's dissatisfaction while also leading to severe abdominal pain and diminished respiratory functions due to impaired function of accessory respiratory muscles which may precipitate shallow breathing, atelectasis, retained secretions, and also lack of patient's cooperation.

Adequate multimodal perioperative pain management improves patient's recovery and survival on a general prospective due to decreased surgical stress response leading to better immunological functions and coagulation profile, and hence improving the outcome of the surgery.

Perioperative epidural analgesia has been associated with improved overall survival but not reduced cancer recurrence. However, patients receiving epidural analgesia with or without general anesthesia have shown longer survival over 5 years period postoperatively than those receiving general anesthesia alone which can be related to better immunological profile and decreased stress response in regional anesthesia group of patients.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA II-III
  • Adult patients (>18 years old)
  • Both sexes
  • Scheduled for radical cystectomy at NCI, CU

排除标准

  • Patient's refusal of the study procedures
  • Allergy to drugs used in the study
  • Patients with chronic pain
  • Patients with coagulopathies (INR > 1.6 or platelets count < 50,000 cc3)
  • Hemodynamically unstable patients (e.g. BP < 90/60)
  • Patients with local or intra-abdominal infections concerning intervention sites and septic patients

研究组 & 干预措施

Quadratus Lumborum Block

Active Comparator

17 cases will be subjected to bilateral Ultrasound-guided Quadratus lumborum block through bilateral catheter insertion for perioperative analgesia.

干预措施: Quadratus Lumborum Block Using Bupivacaine 0.2% (Drug)

Epidural Analgesia

Active Comparator

17 cases will be subjected to epidural catheter insertion for perioperative analgesia (as a control group).

干预措施: Epidural Analgesia Using Bupivacaine 0.25% (Drug)

结局指标

主要结局

Visual analogue pain (VAS) score measurement 24 hours postoperatively

时间窗: 24 Hours Postoperatively

The primary outcome measures visual analogue pain scores in the two groups 24 hours postoperatively

Visual analogue pain (VAS) score measurement 48 hours postoperatively

时间窗: 48 Hours Postoperatively

The primary outcome measures visual analogue pain scores in the two groups 48 hours postoperatively

Visual analogue pain (VAS) score measurement postoperatively

时间窗: 0 Hours Postoperatively

The primary outcome measures visual analogue pain scores in the two groups at the end of surgery

Visual analogue pain (VAS) score measurement 6 hours postoperatively

时间窗: 6 Hours Postoperatively

The primary outcome measures visual analogue pain scores in the two groups 6 hours postoperatively

次要结局

  • Postoperative Nausea and Vomiting(48 Hours Postoperatively)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Sponsor

研究点 (1)

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