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临床试验/NCT06423677
NCT06423677已完成不适用

Evaluation of the Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane (SPSIP) Block in Shoulder Arthroscopies: A Randomized Controlled Prospective Multicenter Study

Kanuni Sultan Suleyman Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
visual analog scale score

研究概览

简要总结

Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. After ensuring aseptic conditions (the block site will be wiped three times with 10% povidone-iodine), the linear ultrasound probe will be covered in a sterile manner. While performing the block, the Hitachi brand linear ultrasound probe will be placed parallel to the scapular spine on the surgical side and will be slid medially. After imaging the 2nd and 3rd ribs on the medial side of the scapular spine, the block needle will be advanced under ultrasound guidance onto the 3rd rib. After contacting the rib with the needle, it will be retracted by 1mm, and the block site will be confirmed by injecting sterile 0.9% NaCl. Subsequently, patients will be administered 30ml of 0.25% bupivacaine in a controlled manner.

Before awakening, both the block group and the non-block group will be administered 1g of paracetamol and 1mg/kg of tramadol intravenously. In the postoperative period, these patients will be provided with multimodal analgesia, including intravenous patient-controlled analgesia (PCA) with 4mg/ml Tramadol HCl in 100ml NaCl. There will be no basal infusion, with bolus doses of 20mg and a lockout period of 20 minutes, and a total dose limitation of 200mg over 4 hours. Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale. The amount of opioid used in the PCA and the need for rescue analgesia (Arveles 50mg intravenously) will be assessed. Patients will routinely receive 4x1g paracetamol in the postoperative period.

详细描述

Patient Positioning and Preparation:

Patient Positioning:

Patients in the block group will be placed in a lateral position with the operated shoulder on top before awakening from surgery. This positioning facilitates access to the block site and ensures patient comfort.

Aseptic Technique:

The block site will be prepared by wiping it three times with 10% povidone-iodine to ensure asepsis.

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
None

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

  • Obtaining consent from the patient and their relative
  • ASA score of I-II
  • No bleeding diathesis
  • No history of anticoagulant use
  • No history of neuropathic diseases such as Diabetes Mellitus
  • Patients aged 18-65 years undergoing shoulder arthroscopy surgery

排除标准

  • Lack of consent from the patient or their relative
  • Patients with an ASA score of III or above
  • Patients with a history of bleeding diathesis
  • Conditions where regional anesthesia is contraindicated
  • Patients with a history of neuropathic diseases
  • Patients under 18 years or over 65 years of age
  • Patients with a history of allergies to the aforementioned medications
  • Patients with an infection at the site where the block will be administered

结局指标

主要结局

visual analog scale score

时间窗: 0, 1, 6, 12, and 24 hours

Patients will be visited at 0, 1, 6, 12, and 24 hours, and they will be asked to draw their visual analog scale (VAS) score on a paper scale.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.

opioid consumption

时间窗: 0, 1, 6, 12, and 24 hours

Patients will be visited at 0, 1, 6, 12, and 24 hours and opioid consumption in the patient controlled analgesia device will be noted.0 means no pain, 10 means the most intense pain. 4 or more Visual analog scale scores means patients need rescue analgesia.

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

Engin Ihsan Turan

Specialist

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (2)

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