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

NCT ID: NCT03584373

Last Updated: 2023-12-18

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-27

Study Completion Date

2022-03-23

Brief Summary

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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

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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

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Nephrolithiasis

Keywords

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Pain Outcomes Ureteroscopy Percutaneous Nephrolithotomy Opioids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Ketorolac Oral Tablet [Toradol]

Intervention Type DRUG

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

Acetaminophen

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Oxycodone Acetaminophen

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Acetaminophen

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Toradol Tylenol Percocet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kara L Watts, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore

Locations

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Jack D. Weiler Hospital

The Bronx, New York, United States

Site Status

Montefiore Hutchinson Campus

The Bronx, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2018-9031

Identifier Type: -

Identifier Source: org_study_id