Miriam Hospital
Providence, Rhode Island, 02906, United States
NCT Number: NCT04597619
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02906, United States
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
Time frame: 1 year or until subject accrual is complete
Number of enrolled patients / patients approached
Time frame: 30 days after procedure
Dropout of enrolled patients
Time frame: Day of procedure to 30 days after procedure
Adverse events (AEs) while inpatient and following discharge
Time frame: Within 24 hours of discharge from hospital
Whether subject is discharged with prescription for opioids or not
Time frame: 24-48 hours
Postoperative inpatient intravenous opioid utilization (morphine milliEquivalents / kg / day)
Time frame: At time of discharge, average of postoperative day 1
Opioid prescriptions written at time of discharge (morphine milliEquivalents / kg / day)
Time frame: At time of discharge, average of postoperative day 1
Nonopioid medications given for pain
Time frame: 24-48 hours
Length of inpatient stay (hours)
Time frame: 30 days
Quantitative number of telephone calls to clinic for pain / discomfort within 30 days via documentation in electronic medical record
Time frame: 30 days
Quantitative number of requests for refills of opioid prescriptions within 30 days via documentation in EMR
Time frame: 30 days
Quantitative number of subject presentations to emergency department for pain within 30 days via documentation in EMR
The Miriam Hospital
Other
Evaluation of a Nonopioid Recovery Pathway After Percutaneous Nephrolithotomy
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