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临床试验/NCT04597619
NCT04597619已完成不适用

Evaluation of a Nonopioid Recovery Pathway After Percutaneous Nephrolithotomy

The Miriam Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Adverse Events

研究概览

简要总结

Evaluation of a nonopioid recovery pathway after percutaneous nephrolithotomy is a pragmatic pilot study that will apply the knowledge and experience gained with development of an outpatient opioid reduction protocol to percutaneous nephrolithotomy (PCNL). We have previously demonstrated that outpatient ureteroscopy and stent placement without postoperative opioid prescriptions is possible in the vast majority of patients. The success of this is dependent upon a multimodal approach to the patient's experience of undergoing endoscopic kidney stone surgery (ureteroscopy) and focuses on the preoperative, perioperative, and postoperative stages of intervention. Our hypothesis is that a novel nonopioid pathway after PCNL is both feasible and safe and will reduce postoperative prescriptions for opioids without impacting clinical outcomes, patient satisfaction or outpatient resources.

详细描述

Evaluation of a nonopioid recovery pathway after percutaneous nephrolithotomy is a pragmatic pilot study which will prospectively compare a cohort undergoing PCNL prior to implementation of the novel nonopioid pathway undergoing the same procedure utilizing the novel nonopioid pathway. Current standard of care following PCNL remains the routine prescription of opioid medications for pain control.

Evaluation of a nonopioid recovery pathway after percutaneous nephrolithotomy has three specific aims:

  1. Demonstrate feasibility and acceptability of the novel nonopioid protocol and describe the barriers to enrollment and reasons for drop out. The feasibility of the protocol will be measured by dropout of enrolled patients and the acceptability of protocol will be measured by number of enrolled patients / patients approached and patient satisfaction via a validated questionnaire.
  2. Describe what adverse events occur to those on the nonopioid protocol as compared to the standard of care. Adverse events occurring as an inpatient will be measured by nursing and physician reporting, and as an outpatient via patient self-reporting, electronic medical records of emergency department visits and telephone calls to clinic.
  3. Begin to reduce overall opioid prescription writing for patients undergoing PCNL at the academic institution. The electronic medical records will be queried for prescriptions written at discharge. The state Opioid Prescription Monitoring Program (PMP) will be queried for a 30-day period following surgery.

After written consent and enrollment, patients will undergo preoperative counseling regarding pain after PCNL in the preoperative holding area prior to surgery. The patient will then undergo percutaneous nephrolithotomy. No procedural changes will be made for study participants. Postoperatively, patients will be admitted to the post-anesthesia care unit and standard of care adjunctive and analgesic medications will be administered. The patient will be admitted to the floor following surgery and postoperative specialized nonopioid PCNL pathway orders will be communicated to nursing staff. The patient's pain will be treated with multimodal nonopioid analgesic agents. Opioid medications will not be withheld for patients with severe pain. On postoperative day one, the patient will be assessed for discharge as in standard of care. They will be asked about their perceived need for a prescription for opioids. If requested, the patient will be given a prescription for a limited quantity of opioids. Nursing staff will complete specialized discharge instructions and patients will be given written instructions regarding medications and activity. Patients will be seen in 7-10 days for stent removal in the office per standard of care, and will complete a validated quality of life survey for pain after kidney stone surgery.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
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

入选标准

  • Patients undergoing primary percutaneous nephrolithotomy at a single academic hospital site.

排除标准

  • Patients will be excluded if currently taking opioids for chronic pain, undergoing concurrent non-PCNL procedure, second-look PCNL (subsequent PCNL after primary PCNL), or present with Chronic Kidney Disease Stage >3 or glomerular filtration rate < 50 mL/min/1.73m2 at time of surgery.
  • Patients with allergy to NSAIDs or have history of NSAID related GI bleeding or ulcers will be excluded.

结局指标

主要结局

Adverse Events

时间窗: Day of procedure to 30 days after procedure

Adverse events (AEs) while inpatient and following discharge

Adherence to the Protocol

时间窗: 30 days after procedure

Dropout of enrolled patients

Protocol Feasibility

时间窗: 1 year or until subject accrual is complete

Number of enrolled patients / patients approached

Opioid Free Discharge

时间窗: Within 24 hours of discharge from hospital

Whether subject is discharged with prescription for opioids or not

次要结局

  • Length of Stay (Hours)(24-48 hours)
  • Postoperative Inpatient Opioid Utilization(24-48 hours)
  • Discharge Opioid Prescriptions(At time of discharge, average of postoperative day 1)
  • Refill Requests(30 days)
  • Nonopioid Discharge Medications(At time of discharge, average of postoperative day 1)
  • Clinic Calls(30 days)
  • Emergency Department Visits(30 days)

研究者

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

David Sobel, M.D.

Assistant Professor of Urology

The Miriam Hospital

研究点 (2)

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