Nephrolithiasis
Conditions
Brief summary
This is a randomized control trial comparing oral ketorolac and opioid medication for the use of post-operative analgesia.
Detailed description
This is a randomized control trial comparing oral ketorolac (10mg, Q6 PRN) and oxycodone (5mg, Q6 PRN) medication for the use of post-operative analgesia after kidney stone removal surgery called percutaneous nephrolithotomy (PCNL). Primary endpoints are visual analog pain scores (VAS) for days 1-5 and day 10 post operatively. Secondary endpoints are pill counts, patient-related outcome survey (PROMIS) scores, emergency room visits, and patient telephone calls. 90 subjects will be enrolled, with 45 in each group.
Interventions
DRUG5mg Oxycodone, Q6 PRN
Oxycodone is an opioid that is used to relieve moderate to severe pain.
DRUG10mg Ketorolac, Q6 PRN
Ketorolac is an NSAID used to relieve moderately severe pain.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Operating surgeon will be blinded to treatment arm intraoperatively (will not be blinded postoperatively)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing scheduled unilateral standard (24Fr), PCNL with at least 2cm stone burden, with expected single access
Exclusion criteria
* Pregnant women * History of chronic opioid abuse * Allergy, hypersensitivity, or other contraindication to NSAID usage such as * eGFR \< 60 mL/min * Peptic ulcer disease or history of gastric bypass * Concurrent use of antiplatelet or anticoagulation therapy (including aspirin) * Thrombocytopenia * Suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis, and those at high risk of bleeding. * Concomitant medications: * Other NSAIDs * Antiplatelet or anticoagulation medications * Probenecid * Pentoxifylline * Allergy, hypersensitivity, or other contraindication to opioids: * Current opioid prescription/usage for any reason, including active treatment with suboxone or methadone * Respiratory depression * Patients with acute or severe bronchial asthma or hypercarbia * Patients who have or is suspected of having paralytic ileus as PCNL done under general anesthesia * Patients with hepatic Impairment * Concomitant medications: * Monoamine Oxidase Inhibitors (MAOIs) * Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics * Diagnosis of chronic pain disorder * Reduced sensation of abdomen or pelvis (e.g. patients with spinal cord injury) * Pre-existing stent or nephrostomy tube * Urinary tract anomalies such as urinary diversion, horseshoe kidney, solitary kidney, urinary stricture disease, ureteropelvic junction obstruction, pelvic kidney, stone in calyceal diverticulum) * Pulmonary disease * Liver disease * Seizure disorders * Subjects taking nephrotoxic medications * Subjects taking medications that can increase sedation risk (benzodiazepines or other sedative hypnotics)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Scores | post-op day 5 and post-op day 10 | Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates no pain and the maximum score of '10' indicates Worst pain imaginable along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pill Count | post-op at day 10 | A pill count will be conducted of each prescribed postoperative medication. |
| Number of Participants Who Called the Office | post-op up to day 10 | Number of participants with pain related calls to the office recorded. |
| Number of Participants With Pain Related Visits | post-op up to day 10 | Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded. |
| Patient-related Outcome Survey (PROMIS) Scores | post-op at day 10 | Patients given a survey containing questions from Patient-related outcome survey (PROMIS) instruments. A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the T-Score. The average T-Score for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. |
Countries
United States
Participant flow
Recruitment details
Participants enrolled from 5-19-2023 to 12-26-2024
Participants by arm
| Arm | Count |
|---|---|
| Opioid Group Patients prescribed 5mg Oxycodone, Q6 PRN postoperatively.
5mg Oxycodone, Q6 PRN: Oxycodone is an opioid that is used to relieve moderate to severe pain. | 43 |
| NSAID Patients prescribed 10mg Ketorolac, Q6 PRN postoperatively.
10mg Ketorolac, Q6 PRN: Ketorolac is an NSAID used to relieve moderately severe pain. | 42 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 3 |
Baseline characteristics
| Characteristic | Opioid Group | NSAID | Total |
|---|---|---|---|
| Age, Continuous | 65 years | 63 years | 64 years |
| Body Mass Index (BMI) | 27.98 kg/m^2 | 27.42 kg/m^2 | 27.46 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 32 Participants | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 10 Participants | 20 Participants |
| Race (NIH/OMB) White | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Female | 18 Participants | 18 Participants | 36 Participants |
| Sex: Female, Male Male | 25 Participants | 24 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 42 |
| other Total, other adverse events | 0 / 43 | 0 / 42 |
| serious Total, serious adverse events | 0 / 43 | 0 / 42 |
Outcome results
Primary
Visual Analog Scale (VAS) Pain Scores
Visual Analog Scale (VAS) to measure pain: The minimum score of '0' indicates no pain and the maximum score of '10' indicates Worst pain imaginable along a line. Participants will be asked to mark the level of their pain along the line. Visual analog scale (VAS) pain scores will be recorded
Time frame: post-op day 5 and post-op day 10
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Opioid Group | Visual Analog Scale (VAS) Pain Scores | post-op day 5 | 4.5 score on a scale |
| Opioid Group | Visual Analog Scale (VAS) Pain Scores | post-op day 10 | 1 score on a scale |
| NSAID | Visual Analog Scale (VAS) Pain Scores | post-op day 10 | 1 score on a scale |
| NSAID | Visual Analog Scale (VAS) Pain Scores | post-op day 5 | 5 score on a scale |
Secondary
Number of Participants Who Called the Office
Number of participants with pain related calls to the office recorded.
Time frame: post-op up to day 10
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Group | Number of Participants Who Called the Office | 5 Participants |
| NSAID | Number of Participants Who Called the Office | 8 Participants |
Secondary
Number of Participants With Pain Related Visits
Number of participants with pain related visits to the office or Emergency Department (ED) visits recorded.
Time frame: post-op up to day 10
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Opioid Group | Number of Participants With Pain Related Visits | 3 Participants |
| NSAID | Number of Participants With Pain Related Visits | 2 Participants |
Secondary
Patient-related Outcome Survey (PROMIS) Scores
Patients given a survey containing questions from Patient-related outcome survey (PROMIS) instruments. A series of person-centered measures that evaluate and monitor physical, mental, and social health in adults and children. 10-item patient-reported questionnaire. standardized to the general population, using the T-Score. The average T-Score for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Time frame: post-op at day 10
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Opioid Group | Patient-related Outcome Survey (PROMIS) Scores | 10 T-score |
| NSAID | Patient-related Outcome Survey (PROMIS) Scores | 10 T-score |
Secondary
Pill Count
A pill count will be conducted of each prescribed postoperative medication.
Time frame: post-op at day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opioid Group | Pill Count | 6.5 pills | Standard Deviation 5 |
| NSAID | Pill Count | 12 pills | Standard Deviation 6 |