Patient Pain and Opioid Use Profile After Total Hip and Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 200
- 主要终点
- Change in Patient Pain level
研究概览
简要总结
The over-prescription and overuse of opioid medications in the United States has recently been recognized as an epidemic. A new law in North Carolina (STOP Act) is aimed to limit opioid prescriptions following any surgical procedure including total hip (THA) and total knee arthroplasty (TKA). However, there is limited evidence regarding patient's pain and actual opioid consumption following THA and TKA that can be used by practitioners as guidance adapting to the new law. The purpose of this study is to investigate patient's pain and pain medication use in the perioperative period (0-6 weeks) following THA and TKA to establish a pain profile and thereby investigating risk factor for increased postoperative pain and opioid pain medication requirements. This study aims to stratify a predication model of postoperative pain and opioid medication requirement after THA and TKA to identify patients with a high propensity for pain, improve preoperative patient education on postoperative pain expectations, thereby helping practitioners implement new postoperative prescriptions limits for THA and TKA patient.
详细描述
Number of subjects: Patient undergoing THA and TKA will be enrolled in this prospective study. Patients older than 18 years of age, with cell phones capable of text messaging, and who agree to participate in this study will be included. Patients who have their primary residence in Missouri will be excluded from this study due to the lack of a state wide narcotic prescription database in Missouri. Up to 240 patients will be enrolled to reach a minimum of 200 participants (100 THA, 100 TKA patients) with complete data from pre to 1 year postoperatively.
Preoperative questionnaires: Patient will be required to complete a preoperative pain catastrophizing score, abrief pain inventory, EQ-5D, a hip disability and osteoarthritis outcome score (HOOS JR.) or knee injury and osteoarthritis outcome score (KOOS JR.) and aAbaseline pain level on a visual analog scale (0-10) will be recorded.
Preoperative pain medication assessment: Preoperative controlled substance use will be assessed using the patient's state residence Controlled Substance Reporting System. Patient socioeconomic status, prior history of pain medication use, and history of drug abuse will be recorded.
Patient preoperative pain sensitivity testing: Patients will then undergo pain algometer testing (FPK algometer, Wagner Instruments, Greenwich CT) to establish an objective baseline pain tolerance. There is no risk to the patient with algometer testing. Pressure algometer testing will be performed in a standard fashion. The probe is applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds. The participant is instructed by the measurer to say "stop" when the sensation of pressure became the very first sensation of pain. There will be three spots to test patients, one for familiarity of the testing and the other 2 for data collection. This is initially performed once on ipsilateral the tibialis anterior as a "warm up." Then 3 measurements are taken on the operative medial epicondyle (for TKA) or ipsilateral lateral iliac crest (for THA) and averaged for the official score. Lastly, 3 measurements are also taken on the contralateral olecranon to measure systemic pain sensitivity. If the contralateral elbow has had prior surgery or active bursitis, the ipsilateral elbow will be used. Of important note, the algometer has a max force lock out of 100N to prevent any harm to the patient. In addition, we will capture dominant handgrip strength measured by the average of 3 attempts on a standard dynamometer.
In-hospital and postoperative pain and medication assessment: Patient's pain scores on an analog scale will be recorded daily from the patient's electronic medical record (lowest, highest, median) while admitted to the hospital. Patient will be contacted daily via text message to report pain scores and pain medication use. Text messaging via cell phones has become very common in the US and has been shown to be efficacious in obtaining longitudinal research data, specifically in assessing pain scores. Patient will be contacted daily via text messaging (Mosio, Seattle, WA).Mosio is a two-way mobile messaging platform that deploys automated text messages to study subjects. Subjects reply to the questions bv text message which are sent and received through mosio.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients older than 18 years of age undergoing primary total hip or total knee replacement
- •Able to give consent to participate in the study
- •Patients have a cell phone capable of text messaging
排除标准
- •Patients from states in the US without a narcotic prescription database (Missouri)
- •Patients with previous joint surgery
结局指标
主要结局
Change in Patient Pain level
时间窗: 1 - 6 weeks on average
Change in Patients' pain level on visual analog scale from 0-10; 0 no pain, 10 worst pain imaginable
次要结局
- hip disability and osteoarthritis outcome score(1 year postoperative)
- Change in opioid consumption(daily for 6 weeks after surgery)
- Change in satisfaction level(daily for 6 weeks after surgery)
- EQ5D(1 year postoperative)
- knee disability and osteoarthritis outcome score(1 year postoperative)
- hip disability and osteoarthritis outcome score (HOOS)(Once before surgery, up to 10 minutes)
- Pain threshold(Preoperative clinic visit, up to 10 minutes)
