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临床试验/NCT01067144
NCT01067144终止3 期

Stanford Accelerated Recovery Trial (START)

Stanford University1 个研究点 分布在 1 个国家目标入组 422 人开始时间: 2010年5月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
终止
入组人数
422
试验地点
1
主要终点
Time to Pain Resolution

研究概览

简要总结

The goal of this study is to determine whether administering Gabapentin prior to surgery affects duration of pain and opioid use post-surgery. The investigators aim to compare gabapentin to placebo in a prospective, randomized clinical trial in which patients will be followed post-surgery until pain resolves and opioid use ceases.

详细描述

Gabapentin was originally developed as an anti-convulsant, but was quickly recognized as a medication with significant analgesic activity in patients with neuropathic pain. More recently it has begun to be appreciated that it may have some benefits in the peri-operative period. Pre-operative Gabapentin reduces preoperative anxiety, early post-operative pain severity, post-operative opioid use and post-operative delirium (presumably through reduced opioid consumption). These same attributes are shared by medications such as NSAIDS and tylenol and the use of peri-operative gabapentin has not permeated the standard of care. Early post-operative pain severity and preoperative anxiety have been implicated in our own research as risk factors for prolonged time to pain resolution and prolonged time to opioid cessation. Since these endpoints are generally synonymous with time to recovery, interventions reducing these times would be seen not just to increase comfort but to actually speed recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Control

Placebo Comparator

Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively

干预措施: Lorazepam (active control) (Drug)

Control

Placebo Comparator

Active placebo given pre-operatively, followed by inactive placebo for 10 doses post-operatively

干预措施: Placebo (inactive) (Drug)

Gabapentin

Experimental

1200 mg Gabapentin preoperative dose, 300 mg of Gabapentin 3-times a day postoperative doses for 72-hour post-surgical period.

干预措施: Gabapentin (Drug)

结局指标

主要结局

Time to Pain Resolution

时间窗: Up to 2 years

Time to pain resolution was defined as 5 consecutive reports of "0" average pain at the surgical site (as reported by the patient on a scale of 0-10, with lower scores corresponding to less pain ("0" = no pain) and higher scores corresponding to more pain). Planned call frequency was daily for 3 months, weekly thereafter up to 6 months, and monthly thereafter up to 2 years after surgery.

次要结局

  • Count of Participants With Continued Opioid Use at 1 Year(Year 1)
  • Count of Participants With Continued Pain at 1 Year(Year 1)
  • Time to Opioid Cessation(Up to 2 years)
  • Count of Participants With Continued Pain at 6 Months(Month 6)
  • Count of Participants With Continued Opioid Use at 6 Months(Month 6)

研究者

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

Jennifer Hah

Assistant Professor of Anesthesiology, Perioperative and Pain Medicine

Stanford University

研究点 (1)

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