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临床试验/NCT04085913
NCT04085913Enrolling By Invitation早期 1 期

Intraoperative Injection of Exparel Effect on Postoperative Opioid Use in Thyroid and Parathyroid Surgery

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年9月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Incidence of opioid use when given Exparel intraoperatively

研究概览

简要总结

The question proposed by this study, is one of patient outcomes. Does intraoperative injection of Exparel decrease postoperative use of opioid pain medications in patients undergoing thyroid and parathyroid surgery? The trial seeks to assess the effect that Exparel has on postoperative pain control.

详细描述

Patients will be identified in clinic as good candidates for surgical intervention based on current standard of care. Once participants are consented, they will be randomly placed into one of three categories. The first category being patients undergoing surgery with local injection of lidocaine and epinephrine as is current practice. The second category of patients will undergo surgery with local injection of bupivacaine HCL and epinephrine preincision. The third group will undergo surgery with local injection of lidocaine and epinephrine preincision and Exparel postincision. As stated above, all patients will undergo surgery as planned, which will be standard of care, with the exception of the local anesthetic and timing of the injection. Postoperatively, patient's pain scores and opioid usage will be evaluated. Patients will be monitored by either using the patient's electronic medical record or by a pain journal that will be provided to the patients. The patients will record their pain using a scale of 1-10 with the FACES scale, as well as medication usage. Patients will return to their first postoperative appointment to further discuss their pain levels as well as medication usage. An ANOVA test will be used to determine if there is a significant difference in the amount of opioids taken postoperatively, in oral morphine equivalents, between these three groups. Opioid usage will then be compared between participants in different categories of local anesthetic to determine if there is an effect of postoperative opioid usage between different anesthetics.

研究设计

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

盲法说明

During the consenting process, participants will be informed about the randomization aspect of the study. However, they will not be told what category/group they will be randomized into. To help with the randomization, the study team will enter the needed patient information into www.randomizer.org, which will categorize the patients into the desired groups.

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

  • Patients over the age of 18 years Patients requiring parathyroid/thyroid surgery based on the standard of care English as primary language

排除标准

  • Patients under the age of 18 years Patients with previous history of opioid abuse Patients with a true allergy to any local anesthetic Patients with a true allergy to any opioid

研究组 & 干预措施

Bupivicaine HCL

Experimental

Thyroid or parathyroid surgery with local injection of bupivicaine HCL and Epinephrine preincision.

干预措施: Bupivacaine Hydrochloride-EPINEPHrine (Drug)

Current Practice

Active Comparator

Thyroid or parathyroid surgery with local injection of lidocaine and epinephrine preincision, as is current practice.

干预措施: Lidocaine Epinephrine (Drug)

Exparel Injection

Experimental

Thyroid and parathyroid surgery with local injection of lidocaine and epinephrine preincison and Exparel postincision

干预措施: Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine (Drug)

结局指标

主要结局

Incidence of opioid use when given Exparel intraoperatively

时间窗: After surgery, patients will be monitored for two weeks, until they return for their first postoperative appointment.

Utilizing pain scale daily diary, we will evaluate the incidence of opioid usage in patients that have undergone thyroid/parathyroid surgery

次要结局

未报告次要终点

研究者

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

Tabitha L. Galloway

Assistant Professor of Clinical Otolaryngology

University of Missouri-Columbia

研究点 (1)

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