Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.

Study Overview
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Brief Summary
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There are two options for postoperative pain management: opioid and non-opioid analgesia. Pain outcomes will be compared in patients undergoing ureteroscopy and percutaneous nephrolithotomy by randomly administering opioid and non-opioid analgesia.

Detailed Description
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Perioperative pain is often managed by opioids. However, post surgical pain management with opioids can often lead to long-term opioid use; additionally, opioids can cause unwanted side effects including respiratory depression that can lead to hypoxia and respiratory arrest, as well as nausea, vomiting, pruritus, ileus, and constipation. As an alternative to opioid perioperative pain management, non-opioid analgesia has been proven to be as effective as opioid management in acute pain. Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and acetaminophen are often utilized as alternatives to opioid analgesia, and have an increased efficacy when combined. Both NSAIDS and acetaminophen have been proven to decrease opioid requirements and have minimized opiate-induced adverse events. In this randomized clinical trial, pain outcomes after ureteroscopy and percutaneous nephrolithotomy will be investigated in patients who are treated with opioids versus a non-opioid regimen of ketorolac and acetaminophen. Percutaneous nephrolithotomy and ureteroscopy are minimally invasive surgical techniques to surgically remove kidney stones. This trial will seek to determine whether non-opioid therapy is noninferior to opioid therapy in the determination of pain intensity as measured by an 11-point numeric rating scale, in which 0 indicates no pain and 10 indicates the worst possible pain, one week after the surgery by telephone call.

Official Title
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Pain Outcomes of Non-opioid Analgesia After Ureteroscopy or Percutaneous Nephrolithotomy for Nephrolithiasis: a Prospective Randomized Controlled Trial.

Conditions
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Nephrolithiasis

Intervention / Treatment
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* Drug: Ketorolac Oral Tablet [Toradol]
* Drug: Acetaminophen
* Drug: Oxycodone Acetaminophen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and Women age>18 years old Presence of renal or ureteral stones suitable for ureteroscopy or percutaneous nephrolithotomy. Uncomplicated ureteroscopy or percutaneous nephrolithotomy Exclusion Criteria: Pregnant/Breastfeeding/Possibly Pregnant Patients Pediatric Patients Sensitive or Allergic to Opioids, Ketorolac, or Acetaminophen Significant Renal Disease Peptic Ulcer Disease Chronic Pain and recovering opiate use Inability to complete questionnaires Non-mobile patients Patients on methadone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This will be an open label, prospective study of approximately 112 subjects undergoing either ureteroscopy or percutaneous nephrolithotomy. Patients who are eligible and choose to undergo ureteroscopy or percutaneous nephrolithotomy will then be asked if they would like to participate in the study and informed consent will be obtained. Patients will then be randomized to control (opioid analgesia) or non-opioid analgesia groups, and given this medication at discharge.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Opioid Analgesia<br>Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed). Acetaminophen - Oral; patient directed as needed. Not prescribed. Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet. | Drug: Ketorolac Oral Tablet [Toradol]<br>* Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.<br>* Other names: Toradol;Drug: Acetaminophen<br>* Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.<br>* Other names: Tylenol;|
| Active Comparator: Opioid Analgesia<br>Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed). Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia. | Drug: Oxycodone Acetaminophen<br>* Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.<br>* Other names: Percocet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction With Pain Relief | The patient will be administered a survey and asked to rate satisfaction with pain relief since the time of surgery and being on the assigned medication. Scoring will be on an 11-point ordinal numeric rating scale, with 0 being not satisfied with pain relief, and 10 being well-satisfied. Higher scores are indicative of greater satisfaction with pain relief | 1 week post surgery | 
| Current Pain Intensity Level | The patient will be administered a survey and asked to rate their current pain intensity level (1 week post surgery) on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of greater pain intensity. | 1 week post surgery | 
| Peak Pain Intensity Level | The patient will be administered a survey and asked to rate the worst/peak pain intensity level since undergoing the surgery. The patient will be asked to rate this worst pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scoring is indicative of worst/peak pain intensity level since the time of surgery | 1 week post surgery | 
| Average Pain Intensity Level | The patient will be administered a survey and asked to rate their average pain intensity level since undergoing surgery. The patient will be asked to rate this average pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of higher average pain intensity. | 1 week post surgery | 
| Perception of an Acceptable Pain Intensity Level | The patient will be administered a survey and asked to rate what their perception or belief of an acceptable pain intensity level would be since undergoing the surgery. The patient will be asked to rate this acceptable pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 equaling no pain, and 10 being the worst possible pain. Higher scores are indicative of the patient's belief of an acceptable pain intensity level. | 1 week post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery | Unused medications is defined as the proportion of prescribed pills that were unused at 1 week post surgery as reported by the patient. More unused medications may indicate the potential to decrease the dosage needed. | 1 week post surgery | 
| Rates of Constipation | Percentage of patients who experienced constipation any time during the week after surgery. A lower percentage of constipation may indicate less incidence of adverse events. | 1 week post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Outcomes, Ureteroscopy, Percutaneous Nephrolithotomy, Opioids