Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- Pain intensity assessed by Numerical Rating Scale (NRS)
研究概览
简要总结
This study aims to evaluate the efficacy of single dose analgesia in combination with local anesthesia to control pain during Trans Ultrasound guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anesthesia alone.
详细描述
Interventional thoracic ultrasonography (TUS) includes both diagnostic and therapeutic procedures. Fine-needle aspiration biopsy , Tru-cut Pleural or lung parenchymal biopsy and Cope or Abrams needles pleural biopsies are examples of diagnostic procedures while ultrasound guided thoracentesis, pleural aspiration for pneumothorax, placement of chest tubes, and indwelling catheter insertion, or pleurodesis are common therapeutic procedures.
Thoracic ultrasound guided procedures are safe and tolerable. Pain, pneumothorax, bleeding, infection, and procedure failure are the possible complications of TUS guided procedures. Lidocaine 1% should be infiltrated prior to the procedure, paying particular attention to the skin, periosteum and the pleura as a local anesthesia.
To reduce pain, analgesia should be considered as premedication. Despite the apparent common sense of this approach, there is little established evidence of the effect from these medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of both genders.
- •Patients with pleural effusion, pneumothorax, lung mass or chest wall mass accessible for thoracic ultrasound guided intervention
排除标准
- •Children and patients less than 18 years old.
- •Pregnant and lactating ladies.
- •Patients with disturbed level of consciousness.
- •Patients with known bleeding disorders.
- •Patients with advanced liver and kidney disorders.
- •Patients with known hypersensitivity to NSAIDS.
- •Patients with chronic chest diseases.
- •Patients who refuse to participate in the trial
研究组 & 干预措施
Diclofenac
Group A will receive a single dose 75 mg IV diclofenac by infusion prior to the procedure
干预措施: Diclofenac (Drug)
Placebo
Group B who will receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Pain intensity assessed by Numerical Rating Scale (NRS)
时间窗: 30 minutes
evaluate the efficacy of single dose analgesia in combination with local anaesthesia to control pain during TUS guided procedures by Numerical Rating Scale , patient is asked to indicate his/her perceived pain intensity , the patient grades their own pain on a scale between 1 to 10
Satisfaction assessed by the Visual Analogue Scale (VAS)
时间窗: 30 minutes
satisfaction assessment by Visual Analogue Scale , series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
performance time of transthoracic ultrasound guided procedures
时间窗: up to 20 minutes
assess the effect of its use with local anaesthesia on procedure performance compared to local anaesthesia alone
次要结局
未报告次要终点
研究者
Mostafa Mahmoud Ahmed AbdAllah
Principal investigator
Assiut University