Clinical trial NCT03584373: Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
Official title: Pain Outcomes of Non-opioid Analgesia After Ureteroscopy or Percutaneous Nephrolithotomy for Nephrolithiasis: a Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nephrolithiasis
Keywords: Pain Outcomes
Ureteroscopy
Percutaneous Nephrolithotomy
Opioids
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction With Pain Relief
timeFrame: 1 week post surgery
measure: Current Pain Intensity Level
timeFrame: 1 week post surgery
measure: Peak Pain Intensity Level
timeFrame: 1 week post surgery
measure: Average Pain Intensity Level
timeFrame: 1 week post surgery
measure: Perception of an Acceptable Pain Intensity Level
timeFrame: 1 week post surgery
Secondary outcomes:
measure: Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery
timeFrame: 1 week post surgery
measure: Rates of Constipation
timeFrame: 1 week post surgery
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jack D. Weiler Hospital
state: New York
city: Bronx
country: United States
facility: Montefiore Hutchinson Campus
state: New York
Study officials:
affiliation: Montefiore
name: Kara L Watts, MD
role: PRINCIPAL_INVESTIGATOR
References: