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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Opioid Analgesia | Experimental | 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. |
|
| Opioid Analgesia | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 week post surgery |
| 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. | 1 week post surgery |
| 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 | 1 week post surgery |
| 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. | 1 week post surgery |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kara L Watts, MD | Montefiore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jack D. Weiler Hospital | The Bronx | New York | 10461 | United States | ||
| Montefiore Hutchinson Campus |
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.
Patients scheduled for surgery between July 2018 and May 2021 were consented and enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 week post surgery |
|
Up to 1 week postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment | Secondary to Anemia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kara Watts, Associate Professor, Department of Urology | Montefiore Medical Center | 718-920-4531 | kwatts@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 12, 2020 | Sep 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D000082 | Acetaminophen |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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.
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|
| Acetaminophen | Drug | Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet. |
|
|
| 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. |
|
|
| 1 week post surgery |
| 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. |
| 1 week post surgery |
| The Bronx |
| New York |
| 10461 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Median | Standard Deviation | kg/m^2 |
|
| Participants with Percutaneous Nephrolithotomy (PCNL) Surgeries | Count of Participants | Participants |
|
| Stent Placement During Procedure | Count of Participants | Participants |
|
| Prior Kidney Stone Removal Surgery | Count of Participants | Participants |
|
| Average Stone Burden | Mean | Standard Deviation | millimeters |
|
| OG001 | 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. |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 week post surgery |
|
|
|
|
| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 week post surgery |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 week post surgery |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 week post surgery |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | proportion of unused pills | 1 week post surgery |
|
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|
|
| 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. | 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. | Posted | Count of Participants | Participants | 1 week post surgery |
|
|
|
| 0 |
| 51 |
| 5 |
| 51 |
| 2 |
| 51 |
| EG001 | 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. | 0 | 54 | 7 | 54 | 1 | 54 |
| Fever | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim, Dysuria or Pain with Urination |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Muscle Cramps | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastrointestinal Pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim, epigastric and lower left quadrant pain |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment | Verbatim, bowel movements |
|
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D052801 | Male Urogenital Diseases |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |