Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
| Status: | Recruiting |
|---|---|
| Conditions: | Nephrology, Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/31/2018 |
| Start Date: | July 27, 2018 |
| End Date: | July 10, 2019 |
| Contact: | Joshua Stern, MD |
| Email: | jstern@montefiore.org |
| Phone: | 718-920-4531 |
Pain Outcomes of Non-opioid Analgesia After Ureteroscopy or Percutaneous Nephrolithotomy for Nephrolithiasis: a Prospective Randomized Controlled Trial.
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.
Pain outcomes will be compared in patients undergoing ureteroscopy and percutaneous
nephrolithotomy by randomly administering opioid and non-opioid analgesia.
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.
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.
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
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