跳至主要内容
临床试验/NCT05791539
NCT05791539招募中不适用

Comparison Between Retrolaminar Block Combined With Erector Spinae Plane Block, and Erector Spinae Plane Block Alone for Post-thoracotomy Pain

Cairo University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
Total amount of morphine consumption in the first 24-hour postoperative in the two groups.

研究概览

简要总结

Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The current study tests two techniques of regional anaesthesia to control post thoracotomy pain

详细描述

Post-thoracotomy pain is a challenging clinical problem that may be associated with increased morbidity and mortality.

The surgical incision produces post-thoracotomy pain (PTP) via damage to the ribs and intercostal nerves, inflammation of the chest wall, pleura or pulmonary parenchyma cutting, and placement of the intercostal chest tube. Acute PTP inhibits the ability to breathe and cough normally. Numerous analgesic techniques are used to relieve PTP, including systemic opioids, regional techniques (such as paravertebral nerve blockade, intercostal nerve blockade, intrapleural analgesia, and epidural opioids with or without local analgesia), cryo-analgesia, and transcutaneous electrical nerve stimulation (TENS).

Emerging research has shown that the novel erector spinae plane block (ESPB) can be employed as a simple and safe alternative analgesic technique for acute post-surgical, post-traumatic, and chronic neuropathic thoracic pain in adults.

ESPB was first reported in 2016 for ipsilateral thoracic analgesia. It was found to be a safe and effective block that can be performed by an emergency physician in the emergency department setting for addressing acute pain due to multiple rib fractures.

Retrolaminar block (RLB) was first reported in 2006 as an alternative approach to PVB. RLB is performed with US imaging or the landmark technique. The efficacy of continuous RLB has been reported for breast cancer surgery .

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
Double (Participant, Investigator)

盲法说明

Randomization will be accomplished through the use of computer-generated random numbers and closed opaque envelopes. Another anesthesiologist who will not be involved in the other parts of the study will open the envelopes to enroll patients. and both patients and outcome assessors will be blinded to the assignment of groups.

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

  • Inclusion criteria
  • Age from 18-65 years.
  • body mass index (BMI) ranged between 20 and 40 kg/m2
  • ASA I, II patients undergoing open thoracic surgery through a posterolateral thoracotomy
  • Exclusion criteria
  • Patient refusal.
  • Sensitivity or contraindication to local anesthetic drugs.
  • History of psychological disorders and/or chronic pain.
  • Localized infection at the site of the block.
  • Coagulopathies, patients on anticoagulants and antiplatelets, and significant liver or renal insufficiency

排除标准

  • 未提供

结局指标

主要结局

Total amount of morphine consumption in the first 24-hour postoperative in the two groups.

时间窗: 24 hours

20ml for ESPB compared to 10ml ESPB added to 10ml RLB.

次要结局

  • .First request of analgesia postoperative(24 hours)
  • Incidence of complications(24 hours)
  • MAP(intraoperative)
  • •Pain score according to VAS score(24 hours)
  • • Heart rate(intraoperative)

研究者

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

sherif Mamdouh Abbas

lecturer

Cairo University

研究点 (1)

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