Preop Education and Opioid Use After Hand and Wrist Fracture ORIF: A Randomized Controlled Trial at a County Hospital
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in total oral morphine equivalents consumed from day of surgery to postoperative day 10
研究概览
简要总结
This study will compare opioid consumption in patients undergoing outpatient surgical fixation of distal radius fractures with and without standardized preoperative education at Grady Memorial Hospital.
详细描述
The proposed research aims to study the impact of preoperative education on postoperative pain control after outpatient surgery for traumatic wrist fractures. The impact of preoperative education will be studied through patient questionnaires and by tracking postoperative opioid consumption as well as instances of unscheduled healthcare contact after surgery. The study will be a randomized controlled trial. This study imposes no more than minimal risk to study participants. Loss of privacy and breach of confidentiality are risks of this study. All data will be stored securely on Microsoft One Drive, a password-protected, encrypted database which requires two-factor authorization. The study population will be patients aged 18-99 years who are undergoing outpatient surgical management of distal radius fractures at Grady Memorial Hospital. No vulnerable populations will be included. Contact will be made with potential study participants at their preoperative clinic visit. Written informed consent will be obtained. Data will not be publicly available. Data will be deidentified, and no members of the team will have access to the code that identifies patients. Data will be collected in the plastic surgery clinic, orthopedic surgery clinic, and preoperative area at Grady Memorial Hospital. The total respondent burden will be 30 minutes.
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
- 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
- •Any patient over the age of 18 years with a closed carpal, metacarpal, or distal radius fracture undergoing outpatient surgical management at Grady Memorial Hospital, who is willing to participate and mentally capable to consent.
排除标准
- •Patients who are inpatients at the time of surgery. Patients who have concomitant injuries on the same extremity as the carpal, metacarpal, or distal radius fracture. Patients with open fractures. Patients unable to tolerate non-steroidal anti-inflammatory drugs (NSAIDs). Non-English speaking patients will be excluded.
- •Adults who are unable to consent will not be included.
- •Individuals who are not yet adults will not be included.
- •Pregnant women will not be included.
- •Prisoners will not be included.
- •Cognitively impaired individuals or individuals with impaired decision-making capacity will not be included.
- •Individuals who speak English will be included. Individuals who have limited English proficiency but speak Spanish as a primary language will not be eligible for inclusion. Spanish-speaking patients will be excluded because the components of the educational protocol (video, questionnaires, surveys) are not available in Spanish.
结局指标
主要结局
Change in total oral morphine equivalents consumed from day of surgery to postoperative day 10
时间窗: Day of surgery, postoperative day 10
Change in oral morphine equivalents consumed from day of surgery to postoperative day 10 (POD 10). The total amount of morphine equivalents consumed between the 2 study arms will be compared.
次要结局
- Total opioid consumption during the postoperative course(Up to postoperative day 10)
- Total number of opioid refills in the postoperative period(Up to postoperative day 10)
- Change in average daily VAS pain scores for early (postoperative day 0-3), middle (postoperative day 4-7), and late (postoperative day 8-10) postoperative period between the two study arms(Baseline, postoperative day 0-3, postoperative day 4-7, postoperative day 8-10)
- Total number of unscheduled healthcare contact (UHC) up to 30 days after surgery(Up to 30 days after surgery)
- Type of reason of unscheduled healthcare contact (UHC) up to 30 days after surgery(Up to 30 days after surgery)
- Change in results of Pain Management quiz after education(Preoperative, day of surgery)
- Postoperative Satisfaction score with education(Postoperative (up to 2 weeks after surgery))
- Percentage of participants with adequate postoperative pain control(Postoperative (Up to 2 weeks after surgery))
研究者
Paul A Ghareeb, MD
Assistant Professor
Emory University