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.
Brief Title
Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Nephrolithiasis
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
* 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
Inclusion 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
* Men and Women age\>18 years old
* Presence of renal or ureteral stones suitable for ureteroscopy or percutaneous nephrolithotomy.
* Uncomplicated ureteroscopy or percutaneous nephrolithotomy
Gender
All
Gender Based
false
Keywords
Pain Outcomes
Ureteroscopy
Percutaneous Nephrolithotomy
Opioids
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03584373
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2018-9031
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Pain Outcomes of Non-opioid Analgesia After Ureteroscopy or Percutaneous Nephrolithotomy for Nephrolithiasis: a Prospective Randomized Controlled Trial.
Primary Outcomes
Outcome Description
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
Outcome Measure
Satisfaction With Pain Relief
Outcome Time Frame
1 week post surgery
Outcome Description
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.
Outcome Measure
Current Pain Intensity Level
Outcome Time Frame
1 week post surgery
Outcome Description
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
Outcome Measure
Peak Pain Intensity Level
Outcome Time Frame
1 week post surgery
Outcome Description
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.
Outcome Measure
Average Pain Intensity Level
Outcome Time Frame
1 week post surgery
Outcome Description
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.
Outcome Measure
Perception of an Acceptable Pain Intensity Level
Outcome Time Frame
1 week post surgery
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
1 week post surgery
Outcome Measure
Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery
Outcome Description
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.
Outcome Time Frame
1 week post surgery
Outcome Measure
Rates of Constipation
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Kara Watts
Investigator Email
kwatts@montefiore.org
Investigator Phone
kwatts