Evaluation of Diaphragm Movement After an Interscalene Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Diaphragm Excursion With Sigh
研究概览
简要总结
The purpose of this study is to evaluate the movement of the diaphragm after an interscalene block with liposome bupivacaine (LB) compared to interscalene block (IB) with bupivacaine. This study will evaluate if there is a possible prolonged phrenic nerve paralysis when using liposome bupivacaine in an interscalene block, using ultrasound.
详细描述
This study will be run concurrently with two other studies comparing bupivacaine to Liposomal Bupivacaine in shoulder surgeries. We will use already randomized patients for our randomization process. For this study in particular we will use an ultrasound machine to scan the diaphragm of any patient who had an Interscalene Block for Total Shoulder Arthroplasy or Rotator Cuff Repair. Patients are to be scanned in an upright sitting position and scanned from a low intercostal or subcostal approach using the liver or spleen as an acoustic window. M Mode will be applied and the range of diaphragmatic movement from the resting expiratory position to deep inspiration (sigh test) will be recorded as was the range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test). The blocks will be done regardless of the study as they are standard of care for pain control. The only intervention is ultrasound examination of the patient's diaphragm at baseline, 3 hours post block in recovery room and on post-operative day 1, and basic spirometry to record FEV1 and FVC via a portable spirometer at the same time points. If patients did stay in hospital on postoperative day 2 we would also evaluate their diaphragm function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients age 18 years and older who are scheduled for shoulder surgery with interscalene block and remain in the hospital for more than 24 hours that are being randomized into a bupivacaine versus liposomal bupivacaine interscalene block study.
排除标准
- •Non English speaking patients.
研究组 & 干预措施
liposomal bupivacaine
These patients receive an interscalene block with liposomal bupivacaine.
干预措施: liposomal bupivacaine (Drug)
bupivacaine
These patients receive an interscalene block with bupivacaine.
干预措施: bupivacaine (Drug)
结局指标
主要结局
Diaphragm Excursion With Sigh
时间窗: change from baseline to 24 hours after block
Evaluation of diaphragm excursion (movement in cm) from rest to sigh in a sitting position.
次要结局
- Diaphragm Excursion With Quick Inspiratory Breath(change from baseline to 24 hours after block)
- Forced Expiratory Volume in 1 Second (FEV1)(change from baseline to 24 hours after block)
- Forced Vital Capacity (FVC)(change from baseline to 24 hours after block)
- FEV1/FVC(change from baseline to 24 hours after block)
