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Completed

NCT Number: NCT03584373

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

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.

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Key information

Conditions

Nephrolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jack D. Weiler Hospital, The Bronx, New York, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Oral Tablet [Toradol]

Drug

Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.

Other names: Toradol

Acetaminophen

Drug

Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.

Other names: Tylenol

Oxycodone Acetaminophen

Drug

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.

Other names: Percocet

Primary outcomes

  1. Satisfaction With Pain Relief

    Time frame: 1 week post surgery

    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

  2. Current Pain Intensity Level

    Time frame: 1 week post surgery

    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.

  3. Peak Pain Intensity Level

    Time frame: 1 week post surgery

    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

  4. Average Pain Intensity Level

    Time frame: 1 week post surgery

    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.

  5. Perception of an Acceptable Pain Intensity Level

    Time frame: 1 week post surgery

    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.

Secondary outcomes

  1. Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery

    Time frame: 1 week post surgery

    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.

  2. Rates of Constipation

    Time frame: 1 week post surgery

    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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Acronym: PO-NOA

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jul 12, 2018
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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