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临床试验/NCT07040618
NCT07040618招募中不适用

Assessing the Effectiveness of Rhomboid Intercostal and Erector Spinae Plane Blocks After Lung Cancer Thoracotomy

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7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
招募中
入组人数
60
试验地点
1
主要终点
24-hour postoperative morphine consumption

研究概览

简要总结

This randomized trial compares rhomboid intercostal block (RIB) and erector spinae plane block (ESPB) for postoperative pain control in lung cancer patients undergoing thoracotomy. Sixty patients will be assessed for 24-hour morphine consumption, pain scores, hemodynamics, recovery time, satisfaction, and side effects. The study aims to identify the more effective technique for enhancing recovery and minimizing opioid use.

详细描述

This randomized clinical trial aims to evaluate the analgesic efficacy of two ultrasound-guided regional anesthesia techniques-Rhomboid Intercostal Block (RIB) and Erector Spinae Plane Block (ESPB)-in female lung cancer patients undergoing thoracotomy at the National Cancer Institute, Cairo University. Thoracotomy is known for causing severe postoperative pain, which, if not effectively managed, can lead to chronic pain and impaired pulmonary function. Traditional techniques like thoracic epidural or paravertebral blocks, while effective, have limitations due to technical complexity and potential complications. Recently, interfascial plane blocks such as ESPB have shown promise for thoracic analgesia, and RIB has emerged as a technique potentially offering superior lateral thoracic wall coverage.

Sixty patients will be randomly assigned to receive either RIB or ESPB 30-45 minutes before surgery. The primary outcome is 24-hour postoperative morphine consumption. Secondary outcomes include visual analog scale (VAS) pain scores, hemodynamic stability, time to first analgesic request, recovery duration, patient satisfaction, and incidence of nausea and vomiting.

General anesthesia will be standardized across both groups. Data will be analyzed using appropriate statistical tests, and ethical approval will be obtained prior to patient enrollment. This study supports multimodal analgesia and aims to inform clinical practice in pain management after oncologic thoracic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • patients undergoing thoracotomy for lung cancer
  • Age ≥ 18 years and ≤ 65 years
  • ASA physical status II or III
  • Body Mass Index (BMI) > 20 kg/m² and < 35 kg/m²
  • Willing and able to provide informed consent

排除标准

  • Patient refusal
  • ASA physical status IV
  • Age < 18 years or > 65 years
  • BMI < 20 kg/m² or > 35 kg/m²
  • Known allergy or contraindication to local anesthetics or opioids used in the study
  • History of chronic pain or psychological disorders
  • Contraindications to regional anesthesia (e.g., local infection, coagulopathy, pre-existing peripheral neuropathy)
  • Severe respiratory, cardiac, hepatic, or renal disease

研究组 & 干预措施

Ultrasound-guided Rhomboid Intercostal Block

Experimental

Patients in this group will receive a rhomboid intercostal block with 20-25 mL of 0.25% bupivacaine injected between the rhomboid major and intercostal muscles under ultrasound guidance 30-45 minutes before surgery.

干预措施: Ultrasound-guided Rhomboid Intercostal Block (Procedure)

Ultrasound-guided Erector Spinae Plane Block

Active Comparator

Patients in this group will receive an erector spinae plane block with 20-25 mL of 0.25% bupivacaine injected deep to the erector spinae muscle at the T4-T5 level under ultrasound guidance 30-45 minutes before surgery.

干预措施: Ultrasound-guided Erector Spinae Plane Block (Procedure)

结局指标

主要结局

24-hour postoperative morphine consumption

时间窗: Within the first 24 hours postoperatively

This outcome measures the total amount of morphine (in milligrams) administered to each patient within the first 24 hours after thoracotomy. Morphine will be given as rescue analgesia when the patient reports a visual analog scale (VAS) pain score of 4 or more. The cumulative dose will be recorded and compared between the Rhomboid Intercostal Block (RIB) and Erector Spinae Plane Block (ESPB) groups to evaluate the relative effectiveness of each regional anesthesia technique in managing postoperative pain.

次要结局

未报告次要终点

研究者

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

Sayed Mahmoud Abed

Assistant professor

Cairo University

研究点 (1)

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