Nephrolithiasis
Conditions
Keywords
Pain Outcomes, Ureteroscopy, Percutaneous Nephrolithotomy, Opioids
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.
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.
Interventions
DRUGKetorolac 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.
DRUGAcetaminophen
Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of 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.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Pain Relief | 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 |
| Current Pain Intensity Level | 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. |
| Peak Pain Intensity Level | 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 |
| Average Pain Intensity Level | 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. |
| Perception of an Acceptable Pain Intensity Level | 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
| Measure | Time frame | Description |
|---|---|---|
| Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery | 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. |
| Rates of Constipation | 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. |
Countries
United States
Participant flow
Recruitment details
Patients scheduled for surgery between July 2018 and May 2021 were consented and enrolled into the study.
Pre-assignment details
A total of 119 patients were consented and enrolled into the study. Of the 119 patients, 14 patients screen failed (did not meet inclusion/exclusion criteria) and were not randomized into the study. Accordingly, 105 patients were randomized into the two arms/groups for this study.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet. | 51 |
| 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.
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. | 54 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 8 |
Baseline characteristics
| Characteristic | Non-Opioid Analgesia | Opioid Analgesia | Total |
|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 15.8 | 47 years STANDARD_DEVIATION 14.7 | 48 years STANDARD_DEVIATION 15.2 |
| Average Stone Burden | 10.9 millimeters STANDARD_DEVIATION 4.5 | 18.1 millimeters STANDARD_DEVIATION 12.1 | 14.7 millimeters STANDARD_DEVIATION 9.8 |
| Body Mass Index (BMI) | 29.0 kg/m^2 STANDARD_DEVIATION 5.8 | 29.2 kg/m^2 STANDARD_DEVIATION 6.3 | 29.1 kg/m^2 STANDARD_DEVIATION 6 |
| Participants with Percutaneous Nephrolithotomy (PCNL) Surgeries | 13 Participants | 18 Participants | 31 Participants |
| Prior Kidney Stone Removal Surgery | 23 Participants | 15 Participants | 38 Participants |
| Race/Ethnicity, Customized Hispanic | 22 Participants | 33 Participants | 55 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 8 Participants | 10 Participants | 18 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 5 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Other/Unknown | 16 Participants | 8 Participants | 24 Participants |
| Region of Enrollment United States | 51 participants | 54 participants | 105 participants |
| Sex: Female, Male Female | 27 Participants | 27 Participants | 54 Participants |
| Sex: Female, Male Male | 24 Participants | 27 Participants | 51 Participants |
| Stent Placement During Procedure | 33 Participants | 35 Participants | 68 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 54 |
| other Total, other adverse events | 2 / 51 | 1 / 54 |
| serious Total, serious adverse events | 5 / 51 | 7 / 54 |
Outcome results
Primary
Average Pain Intensity Level
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.
Time frame: 1 week post surgery
Population: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Opioid Analgesia | Average Pain Intensity Level | 3.34 score on a scale | Standard Deviation 2.57 |
| Opioid Analgesia | Average Pain Intensity Level | 4.50 score on a scale | Standard Deviation 2.69 |
p-value: 0.0495% CI: [-2.26, -0.06]t-test, 2 sided
Primary
Current Pain Intensity Level
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.
Time frame: 1 week post surgery
Population: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Opioid Analgesia | Current Pain Intensity Level | 1.14 score on a scale | Standard Deviation 1.94 |
| Opioid Analgesia | Current Pain Intensity Level | 1.37 score on a scale | Standard Deviation 2.08 |
p-value: 0.5895% CI: [-1.08, 0.61]t-test, 2 sided
Primary
Peak Pain Intensity Level
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
Time frame: 1 week post surgery
Population: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Opioid Analgesia | Peak Pain Intensity Level | 5.61 score on a scale | Standard Deviation 3.41 |
| Opioid Analgesia | Peak Pain Intensity Level | 7.52 score on a scale | Standard Deviation 3 |
p-value: 0.00695% CI: [-3.25, -0.56]t-test, 2 sided
Primary
Perception of an Acceptable Pain Intensity Level
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.
Time frame: 1 week post surgery
Population: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Opioid Analgesia | Perception of an Acceptable Pain Intensity Level | 2.73 score on a scale | Standard Deviation 2.48 |
| Opioid Analgesia | Perception of an Acceptable Pain Intensity Level | 3.28 score on a scale | Standard Deviation 2.85 |
p-value: 0.3395% CI: [-1.67, 0.56]t-test, 2 sided
Primary
Satisfaction With Pain Relief
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
Time frame: 1 week post surgery
Population: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Opioid Analgesia | Satisfaction With Pain Relief | 8.70 score on a scale | Standard Deviation 2.01 |
| Opioid Analgesia | Satisfaction With Pain Relief | 8.85 score on a scale | Standard Deviation 1.49 |
p-value: 0.795% CI: [-0.89, 0.6]t-test, 2 sided
Secondary
Rates of Constipation
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.
Time frame: 1 week post surgery
Population: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-Opioid Analgesia | Rates of Constipation | 11 Participants |
| Opioid Analgesia | Rates of Constipation | 17 Participants |
Secondary
Unused Medications - Proportion of Prescribed Pills Unused at 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.
Time frame: 1 week post surgery
Population: Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Non-Opioid Analgesia | Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery | 0.63 proportion of unused pills | Standard Deviation 0.37 |
| Opioid Analgesia | Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery | 0.58 proportion of unused pills | Standard Deviation 0.35 |
p-value: 0.4795% CI: [-0.1, 0.21]t-test, 2 sided