跳至主要内容
临床试验/NCT06253442
NCT06253442招募中不适用

A Comparative Study Between Ultrasound Guided Interscalene Block and Combined Ultrasound Guided Suprascapular and Axillary Nerve Blocks for Proximal Humerus Fracture Surgeries.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月10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
50
试验地点
1
主要终点
The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.

研究概览

简要总结

A Comparative study Between Ultrasound guided Interscalene Block and Combined Ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture Surgeries.

The aim of this study is to investigate whether (Suprascapular nerve block) and (Axillary nerve block) are effective in providing analgesia for shoulder surgery as an (Interscalene block), while minimizing the occurrence of hemi-diaphragmatic paralysis. We hypothesized that analgesia with a (Suprascapular nerve block and Axillary nerve block) would be noninferior compared with patients receiving an interscalene block and the incidence of hemi-diaphragmatic paralysis would be significantly lower with (Suprascapular nerve block and Axillary nerve block) in proximal humerus fracture surgeries.

详细描述

A Comparative study Between Ultrasound guided Interscalene Block and Combined Ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture Surgeries.

The aim of this study is to investigate whether (Suprascapular nerve block) and (Axillary nerve block) are effective in providing analgesia for shoulder surgery as an (Interscalene block), while minimizing the occurrence of hemi-diaphragmatic paralysis. We hypothesized that analgesia with a (Suprascapular nerve block and Axillary nerve block) would be noninferior compared with patients receiving an interscalene block and the incidence of hemi-diaphragmatic paralysis would be significantly lower with (Suprascapular nerve block and Axillary nerve block) in proximal humerus fracture surgeries.

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
Quadruple (Participant, Care Provider, Investigator, 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 American Society of anesthesiologists' physical status (ASA) I to II.
  • Aged 18 to 65 years.
  • Both sexes.
  • Patients scheduled for proximal humerus fracture surgeries.

排除标准

  • Patient refusal
  • ASA physical status III or more.
  • Patients with known allergy to any of the study drugs.
  • Infection at the site of injection.
  • Patients with history of cardiovascular disease.
  • Patients with renal disease.
  • Patients with hepatic disease.
  • Patients with neuromuscular disease.
  • Presence of any coagulopathy.
  • Chronic opioid, gabapentin or pregabalin use.
  • Patients with history of any psychiatric disorder.
  • BMI more than 35 kg/m2.

结局指标

主要结局

The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.

时间窗: 24 HOURS

The presence of moderate-to-severe pain, defined as visual analog pain scores (VAS) 4 or greater during the first 24 h postoperative.

Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.

时间窗: 24 hours

Analgesic consumption during surgery, in post-anesthesia care unit, and during the first 24 h post-surgery.

Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).

时间窗: 24 HOURS

Individual visual analog pain scores (VAS) at 0, 6, 12 and 24 h postoperatively (VAS; 0 = no pain and 10 = worst pain imaginable).

Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).

时间窗: 24 HOURS

Time to first reported pain and first analgesic request during post-anesthesia care unit stay (in minutes).

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

riham fathy galal

Lecturer

Ain Shams University

研究点 (1)

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