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临床试验/NCT03187899
NCT03187899撤回3 期

Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia

University of Alabama at Birmingham1 个研究点 分布在 1 个国家开始时间: 2018年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
撤回
试验地点
1
主要终点
Pain Score

研究概览

简要总结

The goal of the study is to determine if the addition of a superficial cervical plexus block to a traditional interscalene plexus block will provide superior perioperative analgesia to an interscalene brachial plexus blockade alone for repair of clavicle fractures and non-/malunions.

详细描述

When patients that are possible participants in the study present for surgery, they will be offered the opportunity to participate in the trial as part of the informed consent process. Should they agree to participate, they will be randomized to receive either an interscalene + "sham" superficial cervical plexus block or an interscalene + superficial cervical plexus block. The randomization will have already been predetermined based off of envelopes that will have been created by a research assistant. Within the envelopes the proper paperwork needed to consent a participant along with a label that will be labeled either interscalene + sham superficial cervical plexus block or interscalene + superficial cervical plexus block. This will assign the randomization of each participant (this will be unknown to all study personnel until identified by the label). Their pain scores will be assessed pre-operatively as well as post-operatively .. If they are admitted to the hospital, the PI and/or Co-Investigators will assess their pain scores on a daily basis and follow-up with a phone call to assess their satisfaction with the block. Numerical pain scores (scale of 0-10) will be used to assess post-operative pain with 0 indicating no pain and 10 indicating severe pain. Post-operative pain will be assessed by compiling pain scores from 2 different sources: Numerical pain scores recorded by nursing staff (vitals section of EMR) and also pain scores ascertained by residents during rounds (progress notes). For each pain score, we will record the date and time it was obtained. If they are discharged the same day as surgery, they will receive a phone call within 48 hours to assess their pain scale and satisfaction. We will also assess nausea and vomiting, the amount and type of pain medicine they are taking, and assess if they could tell when their block wore off.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The patient will be blinded as to which block they receive to prevent bias. The Attending performing/overseeing the block will not be blinded to which block is being performed.

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who present for repair of isolated clavicle fractures and non-/malunions that consent to regional anesthesia and to be a part of the study.

排除标准

  • Polytraumatized patients with multiple confounding injuries, patients who are not candidates for either block at the discretion of the Anesthesia Attending, patient refusal to participate in study, patient refusal of regional technique, patients with significant pulmonary disease that will not tolerate possible hemi-diaphragmatic paralysis at the discretion of the attending anesthesiologist.

研究组 & 干预措施

Interscalene block plus "sham"

Sham Comparator

Patients in this group will receive a traditional interscalene block and a "sham" superficial plexus block with ropivacaine and 5-10cc of normal saline. N = 20

干预措施: Ropivacaine (Drug)

Interscalene block plus "sham"

Sham Comparator

Patients in this group will receive a traditional interscalene block and a "sham" superficial plexus block with ropivacaine and 5-10cc of normal saline. N = 20

干预措施: Normal saline (Drug)

Interscalene plus superficial plexus block

Active Comparator

Patients in this group will receive a traditional interscalene block and a superficial plexus block with ropivacaine . N = 20

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Pain Score

时间窗: baseline to 48 hours postoperatively

Average pain score from baseline to 48 hrs postoperatively

次要结局

  • Patient Satisfaction(48 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christopher Godlewski

MD, Assistant Professor

University of Alabama at Birmingham

研究点 (1)

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