Multimodal Analgesic Regimen for Total Hip Arthroplasty: An Initiative to Minimize Postoperative Opioid Use
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score (Visual Analog Scale)
研究概览
简要总结
This study examines whether patients undergoing total hip replacement surgery can manage their pain effectively while using fewer opioid pain medications. Participants will be randomly assigned to one of two groups. The first group will receive the standard postoperative pain medication regimen, with all prescriptions sent directly to their pharmacy as usual. The second group will receive the same medications, but their opioid prescription will only be provided as a printed copy rather than being sent directly to the pharmacy, requiring them to choose whether to fill it. All participants will keep a pain journal and complete questionnaires about their medication intake over the first 21 days post-op as well as there function and wellbeing at follow up visits over 3 months. The goal is to determine whether this approach reduces opioid use while still adequately controlling pain after hip replacement surgery.
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
- •Adult patients age 18 and older
- •Patients who have undergone total hip arthroplasty by a single, fellowship trained Orthopaedic Surgeon.
排除标准
- •Patients with incomplete data in medical records
- •Chronic opioid use in the last 3 months
- •Ipsilateral joint surgery in the last year
- •Cannot tolerate oral medications
- •Swallowing difficulties
- •Intolerance to Tylenol, Celebrex, Robaxin, Neurontin, or Tramadol
- •History of Alcohol abuse
- •History of Drug abuse
- •History of Renal impairment
- •History of Peptic ulcer disease
- •History of GI bleeding
- •Illicit narcotic usage in past 6 months
- •Chronic liver disease
- •Chronic pain syndrome
研究组 & 干预措施
Standard Postoperative Pain Protocol (Control)
Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty. All prescriptions, including opioids, are sent directly to the patient's pharmacy per usual care. Participants complete a postoperative pain journal, medication log, respond to phone/text check-ins regarding pain scores, and complete PROMIS, HOOS Jr., and Harris Hip Score questionnaires at follow-up visits postoperatively.
干预措施: Standard Multimodal Analgesic Regimen with Opioid Prescription (Drug)
Opioid-Reduced Postoperative Pain Protocol (Treatment)
Participants receive the standard postoperative multimodal pain regimen following primary total hip arthroplasty. Opioid prescriptions (Tramadol) are printed and given to the patient rather than sent directly to the pharmacy, requiring the patient to drive to the pharmacy if they choose to fill them. Participants complete a postoperative pain journal, mediation logs, respond to phone/text check-ins, and complete PROMIS, HOOS Jr., and Harris Hip Score questionnaires at follow-up visits postoperatively.
干预措施: Opioid-Reduced Multimodal Analgesic Regimen with Printed Prescription (Behavioral)
结局指标
主要结局
Postoperative Pain Score (Visual Analog Scale)
时间窗: Preoperative baseline through 3 weeks postoperatively
Pain severity measured using a visual analog scale (VAS) scored 0-10, where 0 represents no pain and 10 represents the worst possible pain. Scores collected preoperatively, daily during inpatient admission, daily for the first week post-discharge, then weekly for 2 additional weeks via patient pain journal and phone/text check-ins.
Postoperative Nausea Score (Visual Analog Scale)
时间窗: Preoperative baseline through 3 weeks postoperatively
Nausea severity measured using a visual analog scale (VAS) scored 0-10, where 0 represents no nausea and 10 represents the worst possible nausea. Scores collected preoperatively, daily during inpatient admission, daily for the first week post-discharge, then weekly for 2 additional weeks via patient pain journal and phone/text check-ins.
Opioid Consumption
时间窗: Three weeks post-op
Total opioid consumption measured in morphine milligram equivalents (MME) and by dose and quantity. Inpatient opioid use collected via electronic medical record and the Michigan Automated Prescription System (MAPS). Post-discharge opioid use recorded by the patient in a postoperative pain journal.
Antiemetic Consumption
时间窗: three weeks postoperatively
Total antiemetic consumption recorded by dose and quantity. Inpatient use collected via electronic medical record; post-discharge use recorded by the patient in a postoperative pain journal.
Length of Hospital Stay
时间窗: Perioperative/Periprocedural
Total number of days from surgical admission to hospital discharge following primary total hip arthroplasty.
Episodes of Nausea
时间窗: Three weeks postoperatively
Number of nausea episodes documented. Inpatient episodes collected via electronic medical record; post-discharge episodes recorded by the patient in a postoperative pain journal.
次要结局
- Hip Injury and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR.)(Up to three months postoperatively)
- Harris Hip Score(Up to three months postoperatively)
- PROMIS Physical Function(Up to three months postoperatively)
- Timed Up and Go Test (TUG)(Prior to hospital discharge, assessed up to 2 weeks postoperatively)
- Range of Motion (ROM)(up to three months postoperatively)
- Distance Walked During Physical Therapy Sessions(Up to three months postoperatively)
- Surgical Site Infection(Up to three months postoperatively)
- Acute Prosthetic Joint Infection(Up to three months postoperatively)
- Wound Dehiscence(Up to three months postoperatively)
- PROMIS Pain Interference(Up to three months postoperatively)
- PROMIS Emotional Distress: Depression(Up to three months postoperatively)
研究者
Michael Charters, MD
Medical Doctor
Henry Ford Health System