Randomized Control Trial Evaluating Postoperative Opioid Demands Following Hip Arthroscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Total morphine equivalents taken
研究概览
简要总结
This study will be a prospective, single-blinded, randomized controlled trial (RCT), investigating the influence of the number of opioid pills prescribed following primary hip arthroscopy. All patients who sign the consent form will be enrolled in the suited and randomized to one of the two treatment arms. The intervention group will receive 5 Norco pills, gabapentin (30 mg, once daily for 10 days following surgery), and Tylenol (1000 mg, three times daily for 10 days following surgery) while the control will receive the standard at our practice of 30 Norco pills.
详细描述
Follow-up will take place at 1, 3, 6, and 12 months postoperatively. Variables of interest will include postoperative patient pain scores (i.e. Visual Analog Scale or VAS), total morphine equivalents taken in the first 30 days after discharge, number of unused opioid pills, opioid disposal rates, and standard patient reported outcomes measures (PROMs) including hip disability and osteoarthritis outcome score (HOOS), Harris Hip score (HHS), VAS for pain, international hip outcome tool (iHOT-12), and Hip outcome score (HOS).
For the purpose of this study, the investigators propose two standardized prescribing patterns across all teams. The first would be the control postoperative prescribing pattern and the second would be the experimental opioid reduced prescribing pattern. Patients will not be informed if their postoperative prescriptions are part of the control or opioid reduced prescribing pattern. Of note, patients will be allowed to cross over from the opioid reduced experimental group to the standard of care control group if they have breakthrough pain following surgery.
Timeline of Events:
- Following informed consent during the office visit when surgery is scheduled, all patients will be randomized to one of the postoperative pain management protocols, either the control or opioid reduced.
- Subjects will proceed with hip arthroscopy, including appropriate treatment and documentation of concomitant injuries.
- Over the course of the 1st month postoperatively, patients will complete a 30-day diary detailing which medications they took on each day and their daily average pain level (indicating whether physical therapy was performed). Data pertaining to prescription refills (I.e., number of refills, time to refill), number of left over pain medications, and disposal rates of opioid medications will also be recorded at these time points as well.
- Patients will return for standard of care postoperative visits at 1, 3, 6, and 12 months postoperatively. Patients will be asked to complete PROM questionnaires at the 3, 6, and 12 month follow-up time points
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients age 18-80 years
- •English speaking
- •Opioid naive patient (defined as not taking opioid pills within 6 weeks prior to surgery), confirmed by checking the Illinois Prescription monitoring program
- •Primary hip arthroscopy
- •Written and informed consent for study participation
排除标准
- •Minors (<18 years of age)
- •Opioid tolerant patients
- •Revision surgery
- •Prior infections of the operative joint
- •History of active malignancy within the past 5 years
- •Chronic pain conditions including low back pain, chronic pain syndrome, fibromyalgia
- •History of alcohol or other substance use disorder
- •Other disease states including rheumatologic conditions, diabetes mellitus, hypo/hyperthyroidism, depression, anxiety
- •Grade IV chondral defects
研究组 & 干预措施
Control Group
Control Group will receive the following pain medication regimen:
- Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills
The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days).
干预措施: Control Group Regimen (Other)
Experimental Group - Opioid Reduced
Experimental - opioid reduced: 50% less oxycodone relative to control group
- Tylenol extra strength (1000 mg, three times daily for 10 days following surgery)
- Gabapentin (300 mg at night for 10 days following surgery)
- Norco (hydrocodone-acetaminophen) 5mg-325mg, 5 total pills
The following non-opioid medications are standard of care at our practice following hip arthroscopy and, thus, will be prescribed to patients regardless of the group they are randomized to: aspirin (325 mg, two times daily for 30 days) and Indocin (75 mg extended release, one time daily for 10 days).
干预措施: Opioid reduced regimen (Other)
结局指标
主要结局
Total morphine equivalents taken
时间窗: In the first 30 days after discharge
Standardized reporting of amount of opioids taken
Opioid disposal rates
时间窗: In the first 30 days after discharge
Number of unused pills properly disposed of
Pain Score
时间窗: 12 months postoperatively
Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Number of unused opioid pills
时间窗: In the first 30 days after discharge
Pills not taken by patient
Pain Score
时间窗: 1 month postoperatively
Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Pain Score
时间窗: 3 months postoperatively
Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Pain Score
时间窗: 6 months postoperatively
Visual Analog Scale: unidimensional measure of pain intensity, which has been widely used in diverse adult populations. Score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
次要结局
- Harris Hip score(12 months postoperatively)
- International hip outcome tool(12 months postoperatively)
- Hip outcome score(12 months postoperatively)
- Hip disability and osteoarthritis outcome score(12 months postoperatively)
- Hip disability and osteoarthritis outcome score(1 month postoperatively)
- Hip disability and osteoarthritis outcome score(3 months postoperatively)
- Hip disability and osteoarthritis outcome score(6 months postoperatively)
- Harris Hip score(1 month postoperatively)
- Harris Hip score(3 months postoperatively)
- Harris Hip score(6 months postoperatively)
- International hip outcome tool(1 month postoperatively)
- International hip outcome tool(3 months postoperatively)
- International hip outcome tool(6 months postoperatively)
- Hip outcome score(1 month postoperatively)
- Hip outcome score(3 months postoperatively)
- Hip outcome score(6 months postoperatively)