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临床试验/NCT06133933
NCT06133933Enrolling By Invitation不适用

Total Shoulder Arthroplasty Preoperative Pain Threshold Prospective

The Cooper Health System1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
150
试验地点
1
主要终点
Postoperative opioid consumption

研究概览

简要总结

The purpose of this prospective research study is to evaluate the effects of preoperative pain threshold using a pressure algometer and its effects on postoperative patient satisfaction, return to work, and opioid consumption following Total Shoulder Arthroplasty (TSA). Participants will have their pain threshold measured at the preoperative visit. Postoperatively, they will be followed for 3 months and complete a pain journal for 2 weeks, record their medications consumed, and complete surveys at 2 weeks, 6 weeks, and 3 months. The study team will rely on the completion of the questionnaires, opioid consumption journal, and surveys to establish a correlation between pre-operative pain threshold and post-operative outcome.

详细描述

Prior to undergoing total shoulder arthroplasty (TSA), it is important to counsel the patient on what the postoperative period will look like. Important factors that patients must consider include recovery time, amount of experienced pain, and risks for complications. A lower preoperative pain level has been shown to be a strong predictor of less postoperative pain, less opioid consumption, and greater patient satisfaction. However, pain is relative and typically quantified on a scale of 1-10. The pressure pain algometer is a tool that allows for the quantification of pain threshold and has demonstrated strong reliability with low inter-observer error. The pressure pain algometer has been used to determine preoperative pain thresholds in previous human studies and has been regarded as a suitable tool for assessing pain. Despite the use of this technique in the current literature, data on the application of this tool in Total Shoulder Arthroplasty (TSA) is lacking. There is no current study that has studied the use of preoperative pain thresholds using a pressure pain algometer and its correlation of patient satisfaction, and opioid consumption in TSA patients. This study will be important in closing the knowledge gap in the current literature and provide a better understanding of the usefulness of assessing preoperative pain thresholds with a pressure pain algometer on determining postoperative patient satisfaction, and opioid consumption in patients undergoing total shoulder arthroplasty.

This is a prospective, non-randomized observational study. There will only be one group, the treatment group, consisting of patients undergoing Total Shoulder Arthroplasty (TSA). The study team will recruit patients using a screen for patients who meet inclusion criteria in the institutional electronic medical record platform, EPIC, or recruit patients via physician referral. Inclusion criteria include all patients over 18 years of age who are undergoing TSA. When an eligible patient is selected, the study team will first obtain approval to approach the patient from the treating physician. Once approval is received, a co-investigator will approach them over the phone to inform the patient about a study he or she is eligible for or approach them in person during their visit. All patient eligibility data will be kept in a secure file that is password protected and secured on the Cooper secure network, in a drive behind a firewall. Only study personnel will have access to this information and the documents.

There will be four visits involved in this study, all of which follow the standard of care visit schedule:

Visit 1 is the consenting visit & patients will be consented by the study doctors or co-investigators in the clinic. The preoperative pain threshold score will be obtained.

Visit 2 is the surgery visit the patient will undergo all typical procedures as if they were not in the study. Algometer pain scores and all questionnaires (Demographics, The Tobacco, Alcohol, Prescription medications, and other Substance [TAPS] 1, Visual Analogue Scale [VAS], The 12-item Short Form Survey[SF-12], The Single Assessment Numeric Evaluation [SANE] ) must be completed by this time, either in person at Visit 1, over the phone, via REDCap , or by email prior to this visit, or in pre-op holding where they will sign official consents. The opioid consumption journal will be given to the patient for the patient to record his or her daily opioid intake immediately following TSA. The study team will ask the patients to record their daily opioid consumption in the journal for the first two weeks. Prior to prescribing any prescription narcotics post-operatively, per standard of care, The study team will utilize the Prescription Monitoring Program (PMP) to determine what prescription narcotics the patient is currently on. With the patient's permission, and on the consent form, The study team will check the patient's PMP at 3 months to record opioid consumption.

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

入选标准

  • Patients 18 years or older
  • Patients who are scheduled to undergo a Total Shoulder Arthroplasty

排除标准

  • Patients younger than 18 years
  • Patients who are scheduled to undergo a Total Shoulder Arthroplasty

结局指标

主要结局

Postoperative opioid consumption

时间窗: 3 months

compare preoperative pain threshold with postoperative opioid consumption. The pain threshold will be determined using the pressure algometer/dolorimeter. The term "pain threshold" refers to the measurement of the intensity of a physical stimulus that evokes pain. To estimate the pain threshold, physical force using a mechanical stimulus will be applied with increasing intensity until the patient under evaluation refers to a pain sensation. When the patient declares that the pain is too uncomfortable, the algometer will be removed. This device will quantify the amount of force in pounds that the patient can tolerate. This number is designated as the patient's pain threshold. This value will be correlated with opioid consumption, both by self-reporting and by accessing the Prescription Monitoring Program (PMP). Opioid consumption will be quantified using milligrams of morphine equivalents (MME).

Postoperative satisfaction

时间窗: 3 months

compare preoperative pain threshold with postoperative satisfaction. The pain threshold will be determined using the pressure algometer/dolorimeter. The term "pain threshold" refers to the measurement of the intensity of a physical stimulus that evokes pain. To estimate the pain threshold, physical force using a mechanical stimulus will be applied with increasing intensity until the patient under evaluation refers to a pain sensation. When the patient declares that the pain is too uncomfortable, the algometer will be removed. This device will quantify the amount of force in pounds that the patient can tolerate. This number is designated as the patient's pain threshold. This value will be correlated with patient satisfaction. Patients will be asked how satisfied they are with their pain control. They can answer on a 1-4 scale, with 1 being the lowest satisfaction and 4 being the highest degree of satisfaction.

Postoperative return to work

时间窗: 3 months

compare preoperative pain threshold with postoperative return to work time in days.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Catherine Fedorka MD

Orthopaedic Surgeon, Assistant Professor of Orthopaedic Surgery, Assistant Program Director, Orthopaedic Surgery Residency Program

The Cooper Health System

研究点 (1)

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