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临床试验/NCT01447888
NCT01447888已完成不适用

Perioperative Pain Management In Spine Surgery Patients: Part I

Allina Health System1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Immediate Postoperative Pain Control

研究概览

简要总结

The purpose of this study is a comparison of pain management in opioid-tolerant spine surgery patients using a perioperative dosing goal of 150% of patient's baseline oral morphine equivalent (OME), as compared to standard perioperative dosing, which does not currently account for patients' baseline opiate use.

详细描述

Spine surgery patients experience high levels of pain and report poor pain management in patient satisfaction surveys. Data examined from Allina HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) pain management questions indicate that spine surgery patients report poor pain management. In July, August, and September 2010 patients on the Abbott Northwestern (ANW) spine surgery unit reported 62% on the composite pain score compared to 69% to 71% for ANW overall. During these same three months, the proportion of patients on this unit reporting their pain was always well controlled ranged from 49% to 57% compared to 59% to 64% for the hospital overall. Since ANW serves a high number of spine surgery patients, this poor pain management reporting is a concern for patient care and possibly for future Medicare/Medicaid funding formulas.

Opioid-tolerant patients pose a particular challenge to pain management. The intervention to be tested specifically targets patients who are determined to be opioid-tolerant patients. Opioid-tolerant patients are generally patients who have severe chronic pain, and, thus, are taking pain medication regularly. Tolerance occurs when chronic exposure to a drug diminishes its analgesic effect or creates the need for a higher dose to maintain this effect. Given the severe chronic pain conditions of many patients who are presenting for spine surgery, there is a high level of opioid tolerance among these patients.

While there is no agreed upon definition in the literature about a fixed opioid amount that constitutes "opioid tolerance," Abbott Northwestern Hospital has a working definition of opioid tolerant patients as those who are receiving ≥ 20 mg of oxycodone (or equivalent)/day for > 7 days. This definition is slightly more aggressive than the Institute of Safe Medication Practices definition which set the standard at "at least 30 mg oxycodone/day for greater than a week."

While higher postoperative pain status has been documented in opioid-tolerant patients, very little has been done to examine customizing perioperative opioid dosing to improve pain management in this population. The proposed intervention is designed specifically to test if post-operative pain management can be improved in opioid-tolerant patients using perioperative goal-directed parenteral opioid dosing based on 150% of the patient's baseline oral morphine equivalent (OME). It is important to note this method of perioperative goal-directed parenteral opioid dosing has been used at ANW on spine surgery patients, based on clinical decision of the anesthesiologist. However, this strategy has not been tested compared to standard care.

For this study our research questions are:

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
None

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 must be 18 years or older.
  • Patients must be undergoing spine surgery at ANW.
  • Patients must be assessed to be opioid tolerant based on the established criteria.
  • Patients must be willing and able to provide written informed consent.

排除标准

  • Patients unwilling to comply with research procedures.
  • Patients having surgery for correction of scoliosis.

研究组 & 干预措施

150% Oral Morphine Equivalent (OME)

Experimental

Perioperative goal-directed opioid dosing at 150% of patient baseline oral morphine equivalent (OME) for opioid-tolerant patients

干预措施: 150% Oral Morphine Equivalent (OME) (Drug)

Control

Active Comparator

Standard perioperative dosing, which does not currently account for patients' baseline opiate use.

干预措施: Clinical Judgment (Other)

结局指标

主要结局

Immediate Postoperative Pain Control

时间窗: 4 hours post surgery

We will be assessing if the intervention improves immediate (4 hours) postoperative pain control as compared to the non-intervention group. Measures that will be used to assess immediate post-operative pain include: Verbal pain scores, opioid consumption, and vital signs. Verbal pain scores were reported using the Wong-Baker FACES pain rating scale which ranges from 0 (no hurt) to 10 (hurts worst). Higher numerical scores on the scale indicate more pain, thus a worse outcome.

次要结局

  • Pain Management Improvement at 24 Hours After the Recovery Period(24 hours after the recovery period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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