Discharge Opioid Prescription for Ambulatory Hand and Forearm Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
研究概览
简要总结
The aim of this study is to determine if a standardized evidence-based opioid prescription following elective hand and forearm surgery at Toronto Western Hospital (TWH) will decrease the number of unused opioid pills consumed by patients while still maintaining adequate pain control as compared to usual treatment. Currently, no standardized prescription exists at our institution.
详细描述
This study is a Prospective Randomized Controlled Trial with an aim to determine if a standardized discharge prescription provides effective analgesia while reducing the number of unused opioid pills in the community.
All patients presenting to TWH during the recruitment phase for elective ambulatory hand and arm surgery will be asked to participate in the study. Patients will be given information about the study in the pre-operative surgical clinic by the surgeon assessing them. If agreeable, patients will then be approached for recruitment by a research assistant.
Patients would be randomized to either standardized prescription arm versus control arm (usual prescriptions administered by physician).
The standardized prescription will consist of an opioid prescription for Oxycodone 5mg PO q4-6h PRN. Alternatively, if the patient has an allergy or other contraindication to Oxycodone, Hydromorphone 1mg PO q4-6h PRN or Tylenol #3 1-2 tablets PO q4h PRN will be given. The number of tablets prescribed will depend on the extent of surgical trauma, as per a previously conducted study. As part of the standardized prescription group, patients will receive a handout (encouraging them to use non-opioid analgesics along with the opioid prescription to minimize their narcotic consumption).
Participants will be asked a series of questions via telephone consultation or in the pre-operative waiting area about their current opioid use, as well as their risk for narcotic abuse using the opioid risk tool (ORT). Participants will also be asked to fill out questionnaires assessing components of neuropathic pain (DN-4), any elements of anxiety or depression (HADS), and any tendencies for catastrophizing (PCS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- 否
入选标准
- •1. Patients presenting to TWH for elective ambulatory hand and forearm surgery
排除标准
- •Chronic opioid treatment, defined as more than 6 tablets of Oxycodone 5 mg per day (or equivalent)
- •Cognitive impairment or any other condition causing inability to use 'as required' medication for pain control
- •Language barrier preventing completion of patient diary
- •Patient refusal
研究组 & 干预措施
Standardized Discharge Prescription
Based on a previous study examining mean number of opioid pills used by patients undergoing elective, unilateral hand and forearm surgery
干预措施: Standardized Prescription (Drug)
结局指标
主要结局
Impact of Standardized prescription on quality of analgesia after hand and forearm surgery
时间窗: Twelve weeks after intervention
次要结局
- Incidence of disposal practices of prescribed opioids by patients(One week, Six weeks and Twelve weeks after intervention)
- Patient satisfaction with pain management after discharge (as measured on a 0 to 10 scale, 0 being completely dissatisfied, and 10 being completely satisfied)(One week, Six weeks and Twelve weeks after intervention)
- Incidence of adverse effects of opioid medications experienced by patients(One week, Six weeks and Twelve weeks after intervention)
- Correlation of opioid consumption to functional limitations post-operatively as measured by the Disabilities of Arm Shoulder and Hand (DASH) score(Six weeks and Twelve weeks after intervention compared to pre-intervention)
- The mean number of days patients require post-discharge opioid medications(One week, Six weeks and Twelve weeks after intervention)
- Correlation of opioid consumption to pain scores(One week, Six weeks and Twelve weeks after intervention)
- The correlation between in-hospital opioid analgesic requirements and post-discharge opioid consumption (all converted to oral morphine equivalents)(One week, Six weeks and Twelve weeks after intervention)
- The proportion of patients that require additional opioid prescription(s), on top of what is given at discharge, during the follow-up period, and 12 weeks(One week, Six weeks and Twelve weeks after intervention)
- The incidence of neuropathic pain as diagnosed by DN4 score >3/10(Twelve weeks after intervention compared to pre-intervention)
- Impact of Standardized prescription on number of unused opioid medications after hand and forearm surgery(Six weeks after intervention)
- Impact of Standardized prescription on quality of analgesia after hand and forearm surgery(Six weeks after intervention)