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

Sponsor

Montefiore Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03584373

Collaborator

(none)

140

Enrollment

Locations

Arms

43.9

Actual Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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: Oxycodone Acetaminophen	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.

Study Design

Study Type:

Interventional

Actual Enrollment :

140 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.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 :

Jul 27, 2018

Actual Primary Completion Date :

Mar 23, 2022

Actual Study Completion Date :

Mar 23, 2022

Arms and Interventions

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 Names: 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 Names: 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: 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. Other Names: Percocet

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 Names:

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 Names:

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: 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.

Other Names:

Percocet

Outcome Measures

Primary Outcome Measures

Satisfaction with Pain Relief as reported by the patient on an 11-point numeric rating scale. [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.
Current Pain Intensity Level as reported by the patient on an 11-point numeric rating scale. [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.
Worst Pain Intensity Level as reported by the patient on an 11-point numeric rating scale. [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.
Average Pain Intensity Level as reported by the patient on an 11-point numeric rating scale. [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.
Belief of an acceptable pain intensity level as reported by the patient on an 11-point numeric rating scale. [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

Unused medications as reported by the patient. [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.
Rates of Constipation as reported by the patient. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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