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

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ClinicalTrials.gov Identifier: NCT03584373
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Stern, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Nephrolithiasis Drug: Ketorolac Oral Tablet [Toradol] Drug: Acetaminophen Drug: Percocet Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be an open label, prospective study of approximately 112 subjects undergoing either ureteroscopy or percutaneous nephrolithotomy. Patients who are eligible and choose to undergo ureteroscopy or percutaneous nephrolithotomy will then be asked if they would like to participate in the study and informed consent will be obtained. Patients will then be randomized to control (opioid analgesia) or non-opioid analgesia groups, and given this medication at discharge.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Pain Outcomes of Non-opioid Analgesia After Ureteroscopy or Percutaneous Nephrolithotomy for Nephrolithiasis: a Prospective Randomized Controlled Trial.
Actual Study Start Date : July 27, 2018
Estimated Primary Completion Date : June 11, 2020
Estimated Study Completion Date : July 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Non-Opioid Analgesia

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.

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.
Other Name: Toradol

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

Active Comparator: Opioid Analgesia

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.

Drug: Percocet
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.




Primary Outcome Measures :
  1. Satisfaction with Pain Relief as reported by the patient on an 11-point numeric rating scale. [ Time Frame: 1 week post surgery ]
    The patient will be asked to rate satisfaction with pain relief since undergoing surgery and being on the assigned medication. This will be on an 11-point scale, with 0 being not satisfied with pain relief, and 10 being well-satisfied.

  2. Current Pain Intensity Level as reported by the patient on an 11-point numeric rating scale. [ Time Frame: 1 week post surgery ]
    The patient will be asked to rate the current pain intensity level. Patient will be asked to rate this intensity level on a scale 0-10, with 0 being no pain, and 10 being the worst possible pain.

  3. Worst Pain Intensity Level as reported by the patient on an 11-point numeric rating scale. [ Time Frame: 1 week post surgery ]
    The patient will be asked to rate the worst pain intensity level since undergoing the surgery. The patient will be asked to rate this intensity level on a scale 0-10, with 0 being no pain, and 10 being the worst possible pain.

  4. Average Pain Intensity Level as reported by the patient on an 11-point numeric rating scale. [ Time Frame: 1 week post surgery ]
    The patient will be asked to rate the average pain intensity level since undergoing surgery. The patient will be asked to rate this intensity level on a scale 0-10, with 0 being no pain, and 10 being the worst possible pain.

  5. Belief of an acceptable pain intensity level as reported by the patient on an 11-point numeric rating scale. [ Time Frame: 1 week post surgery ]
    The patient will be asked to rate the belief of an acceptable pain intensity level for the current time after undergoing this surgery 1 week prior. The patient will be asked to rate this intensity level on a scale 0-10, with 0 being no pain, and 10 being the worst possible pain.


Secondary Outcome Measures :
  1. Unused medications as reported by the patient. [ Time Frame: 1 week post surgery ]
    Number of prescribed pills that were unused 1 week post surgery. More unused medications may indicate the potential to decrease the dosage needed.

  2. Rates of Constipation as reported by the patient. [ Time Frame: 1 week post surgery ]
    Incidence of constipation in subjects. This will be measured by whether the patient experienced constipation in the week after surgery. Lower rates of constipation may indicate less incidence of adverse events.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584373


Contacts
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Contact: Joshua Stern, MD 718-920-4531 jstern@montefiore.org
Contact: Matthew S DeMasi, BS 347-216-5445 mdemasi@mail.einstein.yu.edu

Locations
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United States, New York
Jack D. Weiler Hospital Recruiting
Bronx, New York, United States, 10461
Contact: Joshua Stern, MD    718-920-4531    jstern@montefiore.org   
Contact: Matthew DeMasi, BS    347-216-5445    mdemasi@mail.einstein.yu.edu   
Montefiore Hutchinson Campus Recruiting
Bronx, New York, United States, 10461
Contact: Joshua Stern, MD    718-920-4531    jstern@montefiore.org   
Contact: Matthew DeMasi, BS    347-216-5445    mdemasi@mail.einstein.yu.edu   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Joshua Stern, MD Montefiore

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Responsible Party: Joshua Stern, Associate Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03584373     History of Changes
Other Study ID Numbers: 2018-9031
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Joshua Stern, Montefiore Medical Center:
Pain Outcomes
Ureteroscopy
Percutaneous Nephrolithotomy
Opioids

Additional relevant MeSH terms:
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Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Analgesics, Opioid
Acetaminophen, hydrocodone drug combination
Oxycodone
Acetaminophen
Ketorolac
Ketorolac Tromethamine
Analgesics, Non-Narcotic
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action