Incidence of Hemidiaphragmatic Palsy After Single Shot Interscalene Block for Pain Relief in Shoulder Surgery
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary outcome of this study is to find out the incidence of hemi-diaphragmatic palsy associated with interscalene block done under ultrasound guidance. Primary hypothesis:
研究概览
简要总结
Primary objective of this study is to find out the incidence of hemi-diaphragmatic palsy associated with interscalene block done under ultrasound guidance.
Primary hypothesis:
• There is an incidence of hemidiaphragmatic palsy ranging fron 33-100 % after an interscalene block.
Secondary hypothesis
- The incidence of hemidiaphragmatic palsy is much less than 33% when the block is done using ultrasound.
- The incidence of hemi-diaphragmatic palsy is directly proportional to volume of local anaesthetic injected.
- The incidence of hemi-diaphragmatic palsy is directly proportional to concentration of local anaesthetic injected.
详细描述
Patients of either sex belonging to American Society of Anesthesiologists status 1-3 scheduled for elective shoulder surgery as an outpatient basis, planned for an interscalene block will be included in this study over a period of one year.
Potential patients will be identified from the surgeons' list. The PI or one of the co-investigators will contact them in the surgical day care in the morning of surgery and will be given information about the study. Documented informed consent will be obtained.
After obtaining informed consent, they will be examined for their diaphragm position using an ultrasound prior to block placement .
All patients will have the block initiated in the block room using standard monitors and sedation as per the standard practice in this hospital.
The patients will undergo an ultrasound examination for their diaphragm position 5 mins and 10 mins after the completion of the nerve block. Ipsilateral ( same side as the block) and contralateral ( opposite side of block) hemi-diaphragmatic excursion will be measured with the patients in supine position during quiet inspiration ,deep inspiration and forceful sniff.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Control Group:
- •Age between 18 - 80 years old Elective shoulder surgery Same day discharge Inform consent signed
排除标准
- •Ongoing Major psychiatric problems Narcotic Abuse/ Drug dependency Mental impairment / inability to cooperate with postoperative evaluation/Inability to give informed consent
结局指标
主要结局
Primary outcome of this study is to find out the incidence of hemi-diaphragmatic palsy associated with interscalene block done under ultrasound guidance. Primary hypothesis:
时间窗: 1 year
We intend to scan all patients undergoing ISB who consent to be part of the study, for the diaphragm excursion to find out the incidence at our institute.
次要结局
- In addition we will also do Spirometric analysis and assess for symptomatic respiratory insufficiency/ distress. Thus we can find the incidence of clinically significant hemi-diaphragmatic palsy.(1 year)
研究者
Shalini Dhir
Associate Professor, Department of Anaesthesia
Lawson Health Research Institute