NCT03584373

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nephrolithiasis

Interventions

Type	Name	Description
DRUG	Ketorolac Oral Tablet [Toradol]	Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
DRUG	Acetaminophen	Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
DRUG	Oxycodone Acetaminophen	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.

Timeline

• Start date: 2018-07-27
• Primary completion: 2022-03-23
• Completion: 2022-03-23
• First posted: 2018-07-12
• Last updated: 2023-12-18
• Results posted: 2023-12-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study