跳至主要内容
临床试验/NCT06519708
NCT06519708已完成不适用

Analgesic Efficacy of Erector Spinae Plane Block vs External Oblique Intercostal Plane Block in Subcostal Cancer Surgeries: A Randomized Controlled Study

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年7月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
Total amount of morphine consumption

研究概览

简要总结

This study aims to evaluate the impact of ultrasound-guided erector spinae plane block compared to ultrasound-guided external oblique intercostal plane block regarding management of postoperative acute pain in patients undergoing above Umbilical surgical procedure.

详细描述

Subcostal incisions in cancer surgeries as in hepatectomy and nephrectomy are a cause of severe pain and can lead to significant respiratory impairment. Regional anesthesia of the trunk and abdominal wall is usually centered on epidural analgesia.

Erector spinae plane block (ESPB) is the deposition of local anesthetic (LA) in the interfascial plane at the paraspinal region. It provides effective visceral and somatic analgesia.

The recently described external oblique intercostal plane block (EOIPB) is a simple, effective, and convenient block, particularly in the context of morbid obesity, at which local anesthetic (LA) is deposited in the interfacial plane deep to external oblique muscle at the sixth intercostal space. It provides a blockade of the thoracoabdominal nerves at the level of T6 to T10.

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
Single (Participant)

入排标准

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

入选标准

  • Age (18-65) Years.
  • Both sexes.
  • Body mass index (BMI): (20-40) kg/m
  • American Society of Anesthesiology (ASA) physical status II, III.
  • Type of surgery; unilateral subcostal incision in hepatectomy and nephrectomy.

排除标准

  • Patient refusal.
  • Subcostal incisions that are crossing the midline or midline incision.
  • Age <18 years or >65 years
  • BMI <20 kg/m2 and >40 kg/m2
  • Known sensitivity or contraindication to drugs used in the study
  • Contraindication to regional anesthesia e.g. local infection at the site of introduction, pre-existing peripheral neuropathies, and coagulopathy.
  • Pregnancy.
  • Physical status ASA IV
  • patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
  • patients with a history of drug abuse
  • patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
  • All patients who are going to have severe intra- or post-operative bleeding or will require postoperative mechanical ventilation are also excluded from the study.

研究组 & 干预措施

Erector Spinae Plane Block

Active Comparator

Patients will receive an ultrasound-guided erector spinae plane block with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.

干预措施: Erector Spinae Plane Block (Drug)

External Oblique Intercostal Plane Block

Experimental

Patients will receive an ultrasound-guided external oblique intercostal plan block Intraoperative with the injection of 30 ml bupivacaine 0.25% after induction of general anesthesia.

干预措施: External Oblique Intercostal Plane Block (Drug)

结局指标

主要结局

Total amount of morphine consumption

时间窗: 24 hours postoperatively

Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. A maximum dose of 0.5 mg/kg/24hours of morphine is allowed.

次要结局

  • Time of first rescue analgesia(24 hours postoperatively)
  • Mean arterial blood pressure(Till the end of surgery)
  • Complications(24 hours postoperatively)
  • Total amount of intraoperative fentanyl consumption(Intraoperatively)
  • Heart rate(Till the end of surgery)
  • Patient satisfaction(24 hours 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

Osama Sayed Mohamed Ibrahim

Assistant Lecturer of Anesthesiology, Intensive Care Unit and Pain Medicine, Faculty of Medicine, Cairo University, Cairo, Egypt.

National Cancer Institute, Egypt

研究点 (1)

Loading locations...

相似试验