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临床试验/NCT03636542
NCT03636542已完成4 期

Evaluation of Diaphragm Movement After an Interscalene Block

University of Minnesota1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2018年8月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

These patients receive an interscalene block with liposomal bupivacaine.

干预措施: liposomal bupivacaine (Drug)

bupivacaine

Active Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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