Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery. (PO-NOA)

Montefiore Medicine Academic Health System

Status and phase: Completed; Phase 3

Conditions: Nephrolithiasis

Treatments: Drug: Ketorolac Oral Tablet [Toradol]; Drug: Oxycodone Acetaminophen; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT03584373

2018-9031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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119 participants in 2 patient groups

Non-Opioid Analgesia

Experimental group

Description:

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.

Treatment:

Drug: Acetaminophen

Drug: Ketorolac Oral Tablet [Toradol]

Opioid Analgesia

Active Comparator group

Description:

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.

Treatment:

Drug: Oxycodone Acetaminophen