N/A
N=30
Evaluation of a Nonopioid Recovery Pathway Following Surgery for Kidney Stones
Nephrolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT04597619 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Protocol Feasibility — 14; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Novel Nonopioid Pathway (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Miriam Hospital
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Protocol Feasibility |
14; 10 | — |
| PRIMARY Adherence to the Protocol |
14; 6 | — |
| PRIMARY Adverse Events |
0; 0 | — |
| PRIMARY Opioid Free Discharge |
10; 6 | — |
| SECONDARY Postoperative Inpatient Opioid Utilization |
4.0; 0 | — |
| SECONDARY Discharge Opioid Prescriptions |
30.0; 0 | — |
| SECONDARY Nonopioid Discharge Medications |
— | — |
| SECONDARY Length of Stay (Hours) |
1; 1 | — |
| SECONDARY Clinic Calls |
1; 1 | — |
| SECONDARY Refill Requests |
0; 0 | — |
| SECONDARY Emergency Department Visits |
2; 0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing primary percutaneous nephrolithotomy at a single academic hospital site.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04597619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.