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临床试验/NCT02926573
NCT02926573已完成4 期

Perioperative Gabapentin Use In Head And Neck Mucosal Surgery Patients: A Randomized Clinical Trial

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2016年6月24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
123
试验地点
1
主要终点
Change in Daily Narcotic Consumption

研究概览

简要总结

Patient satisfaction with healthcare is increasingly being utilized as a metric to reflect provider and hospital quality of care. Furthermore, at the core of a healthcare team and healthcare system is the desire to provide patients with the best possible care in order to achieve the best possible outcomes. Providers have the duty to identify areas of needed improvement within the domains of treatment. An area of need that is ubiquitous within medicine is pain control; in this case acute postoperative pain control is the targeted condition. Studies have already shown that better control of acute postoperative pain leads to shortened hospital stays, reduced hospital costs and patient morbidity, improved patient satisfaction and a reduced likelihood of developing chronic pain. Research within the field of pain management has definitively revealed that a combination of different medication regimens can control acute postoperative pain better than narcotics alone. In particular, the medication gabapentin has been shown to improve acute postop pain in many kinds of surgical settings, and it is a safe medication with arguably fewer side effects than narcotics. The investigators know that certain groups of post surgical otolaryngology patients can be at risk for high levels of postoperative pain. Given all of this information, physicians have a responsibility to utilize medications such as gabapentin to do a better job of controlling patient's pain. This investigation is a quality improvement project designed to elucidate the benefits of gabapentin in pain management in patients undergoing surgery of the head and neck mucosal surfaces. It will provide much needed data in an understudied population and ultimately will improve the practice of pain management, patient satisfaction and quality of care delivered in the Barnes otolaryngology department.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

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

  • Subjects undergoing definitive mucosal head and neck resection including oral cavity, oropharynx, larynx, and hypopharynx
  • At least one night of planned inpatient stay

排除标准

  • Incapable of giving informed consent
  • Age less than 18
  • Glomerular Filtration Rate (GFR) less than 30
  • Allergy to gabapentin
  • Baseline gabapentin or lyrica use
  • Chronic opioid use for over six months

研究组 & 干预措施

Gabapentin

Active Comparator

Gabapentin liquid by mouth or Per Tube 300mg twice a day

干预措施: Gabapentin (Drug)

Placebo

Placebo Comparator

Placebo liquid by mouth or Per Tube twice a day

干预措施: Placebo (Drug)

结局指标

主要结局

Change in Daily Narcotic Consumption

时间窗: Daily from date of randomization until post-op day 2 or date of discharge, whichever comes first.

Total amount of narcotic use in morphine equivalents will be divided by the total hours of inpatient hospitalization, multiplied by 24 hours, to obtain the daily narcotic consumption.

次要结局

  • Patient Reported Post-treatment Pain Satisfaction as Measured by Overall Pain Control(Once on post-op day 2 or day of discharge, whichever comes first)
  • Mean Pain With Resting Score as Measured by VAS(Baseline through post operative day 3)
  • Mean Pain With Coughing Score as Measured by VAS(Baseline through post operative day 3)
  • Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Participant's Pain Was Well Controlled(Once on post-op day 2 or day of discharge, whichever comes first)
  • Patient Reported Post-treatment Pain Satisfaction as Measured by How Often the Hospital Staff Did Everything They Could do to Help the Participant's Pain(Once on post-op day 2 or day of discharge, whichever comes first)
  • Mean Pain With Swallowing Score as Measured by VAS(Baseline through post operative day 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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