Comparing Opioid Prescription Patterns in Total Joint Arthroplasty Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient
研究概览
简要总结
The United States constitutes <5% of the world's population but over 80% of the opioid supply and 99% of the hydrocodone supply. In 2014, there were 18,893 deaths from prescription drug overdose, and orthopaedic surgeons are the third highest prescribing physicians for opioids. Surgeons often prescribe opioids to minimize postoperative pain and to reduce the likelihood of readmission for pain. Available data suggests that orthopaedic surgeons are the most likely physicians to prescribe opioids to Medicare patients, whose opioid prescriptions are over 7 times more likely to come from an orthopaedic surgeon than another type of physician, but orthopaedic surgeons also had the highest readmission rate for post-operative pain. Many studies have investigated the utilization of opioids after surgery to assess surgeon's tendencies to overprescribe, demographics of those likely to overuse, and adverse events of opioid abusers.
The primary purpose of this randomized controlled trial is to determine whether prescribing fewer opioid pills per prescription reduces the total amount of opioids taken, even while allowing equal total opioid availability via increased frequency of prescription availability.
详细描述
A recent paper by Kim et al prospectively investigated opioid utilization after upper extremity surgery. This study (n=1,416) showed an opioid utilization rate of just 34%, taking an average 8.1 pills out of 24 prescribed. Patients age 30-39, those having joint procedures, upper extremity/shoulder surgery, or self-pay/Medicaid insurance were all far more likely to overuse opioids. The study concluded that their surgeons prescribed 3 times the required opioid following surgery and gave recommendations for opioid distribution based on location, procedure type, and patient risk factors. This study's identification of over prescription is congruent with a study completed by Bates et al that showed 67% of patients had a surplus of medications, with 92% not receiving proper medication disposal instructions.
Other recent literature has attempted to risk stratify patients who are more likely to abuse prescription opioids. Morris et al identified various risk factors including: family history of substance abuse, nicotine dependency, age <45, psychiatric disorders, and lower level of education. These risk factors are associated with aberrant behaviors (non-compliance, early refill request, "lost or stolen" medication), which should raise concerns for any provider prescribing opioids.
Studies have shown that patients who are on chronic opioid therapy before surgery have worse outcomes. Nicholas Bedard et al compared chronic opioids users (n= 35,068) versus those who were opioid-naïve at the time of total knee arthroplasty (TKA) and found the opioid group had more opioid scripts filled per patient at discharge as well as at 3, 6, and 9 months (0.63 scripts/patient vs. 1.2 scripts/patient, p<0.05). These patients also had a higher Charlson Comorbidity Index (p<0.05) and higher rates of respiratory failure, acute kidney failure, pneumonia, all post-operative infections, and infections requiring return to the OR. The study concluded patients should have their opioid consumption controlled during the pre-operative and peri-operative period.
In addition to the complications of opioid medications experienced by orthopaedic patients, a recent nationwide retrospective analysis presents an unintended yet severe problem associated with opioid prescriptions. The incidence of pediatric hospitalizations for opioid toxicity nearly tripled from 1997 to 2012. The over-prescription of opioids creates a readily available source for accidental ingestion by younger children and for intentional opioid overdose by older pediatric/adolescent patients. In fact, a family member's leftover pills have been described as the number one source for pediatric opioid overdose. Moreover, the Center for Disease Control reported that in 2015 the U.S. saw its highest incidence of opioid-related death.9 Given the frequency and severity of opioid diversion and misuse, orthopaedic surgeons should consider the best methods for controlling patients postoperative pain and also avoid facilitating opiate misuse, whether by orthopaedic patients or other community members. With this goal in mind, our study will investigate regimens for effective postoperative pain control that also minimize the total amount of opioids prescribed.
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
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •any patient > 18 years of age scheduled for primary total hip or knee arthroplasty who is not consuming opioids during the 4 weeks prior to surgery
排除标准
- •patients consuming opioids during the 4 weeks prior to surgery
- •patients who are allergic to oxycodone or refuse to take oxycodone
- •patients with a history of opioid dependence or illegal or "off-label" opioid use
- •patients undergoing a revision total knee or total hip arthroplasty
- •any patient less than 18 years of age
研究组 & 干预措施
1 prescription
Receives 90 pills in single prescription at discharge from hospital
干预措施: opioid pain pills (Drug)
3 prescriptions
Receives 30 pill prescription at discharge from hospital. Two refills available if requested.
干预措施: opioid pain pills (Drug)
结局指标
主要结局
Morphine Milligram Equivalents (MME) of Oxycodone Tablets Taken by Patient
时间窗: 30 days
Self-reported by patient, we are asking for the number of Oxycodone taken by patients (5mg doses). This will be verified with patient bringing their pill bottle in and counted by a study investigator.
次要结局
- Postoperative Inpatient Pain Scores(assessed daily from time of surgery to discharge from hospital (1 days - 2 weeks), Day 14 scores reported)
- Postoperative Patient Reported Outcomes of Opioid naïve Patients Undergoing THA or TKA Between August 2017 and April 2018(90 days post operative (higher values represent better functioning total hip or total knee replacements).)
- Preoperative Patient Reported Outcomes(10 days prior to surgery (higher values represent better functioning total hip or total knee replacements).)
- Compliance(90 days)
- Postoperative Outpatient Pain Scores(Days 1-3, 1 week, 2 weeks, and 3-4 weeks post discharge from surgery)
- Complications(90 days from time of surgery)
- Postoperative Inpatient Opioid Utilization(from time of surgery to discharge from hospital (1 day - 2 weeks))
- Number of Tablets Received From Pharmacy That Went Unused(90 days)
研究者
Craig J Della Valle, MD
Attending Physician
Rush University Medical Center