Anesthesia, Anesthesia Morbidity, Nephrolithiasis, Pain, Acute, Pain, Postoperative, Perioperative/Postoperative Complications, Urolithiasis, Urologic Diseases
Conditions
Keywords
Pregabalin, Perioperative medicine, Opioid sparing, Urolithiasis, Ureteroscopy
Brief summary
The investigators propose a pilot clinical trial on the use of perioperative pregabalin in order to decrease ureteral stent related symptoms and decrease opioid usage after ureteroscopy with stent placement. Patients undergoing ureteroscopy with stent placement will receive a single dose of 300 mg pregabalin PO in the preoperative area. This work will assess safety and feasibility of studying this regimen at our institution, with the aim of performing a randomized, placebo-controlled, double-blinded study in the future.
Interventions
DRUGPregabalin 300mg
One 300mg capsule will be administered PO 1 hour before surgery
Sponsors
University of Missouri-Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
There will be no blinding for this pilot
Intervention model description
All participants will receive 300mg PO pregabalin one hour before procedure start
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject Population Undergoing elective ureteroscopy with stent placement by Dr. Murray at University of Missouri Hospital and affiliated facilities Subject Inclusion Age \>= 18 years Subject Exclusion * Renal insufficiency (eGFR \< 30 mL/minute/1.73 m2) * Chronic indwelling ureteral stent * Chronic opioid use * History of opioid abuse * Chronic gabapentinoid use * Plan for inpatient hospitalization * Pregnancy * Inability of the patient to consent for themselves in English * Allergy to gabapentinoid * Liver failure or hepatic dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Adverse Events Related to Study Drug | Day of surgery | — |
| Number of Participants Who Were Administered the Study Drug Correctly | Day of surgery | — |
| Respondent Reported Usability of Instruments | 30 days post-op | Number of patients able to complete 30 day post op questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Use | Up to 1 year post-op | Number of patients stating that they had used opioids on any survey. |
| Patient Satisfaction | First 30 post-operative days | Score on standardized evaluation of patient satisfaction at 7-days post-op. This was on a scale from 1) very dissatisfied to 5) very satisfied. Higher scores are better. |
| Unplanned Healthcare Contacts | First 30 post-operative days | Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients. |
| Amount of Opioid Use | Up to 1 year post-op | Total amount of opioid used for any indication at several time points, in oral morphine equivalents. This is the sum for all patients. |
| Early Post-op Stent Related Symptoms | Post-op day 3 | Ureteral Stent Related Symptom Questionnaire (USSQ) score, sum of urinary index score, pain index score, and general health index score. Minimum is 24. Maximum is 162. Higher scores indicate a worse outcome. |
| Early Post-op Opioid Needs | First 30 post-operative days | Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregabalin 300mg 300mg pregabalin, PO, once, 1 hr before surgery
Pregabalin 300mg: One 300mg capsule will be administered PO 1 hour before surgery | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Pregabalin 300mg | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 8 Participants | — |
| Age, Continuous | 40.2 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 10 Participants | — |
| Sex: Female, Male Female | 3 Participants | — |
| Sex: Female, Male Male | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 6 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Number of Participants Who Were Administered the Study Drug Correctly
Time frame: Day of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregabalin 300mg | Number of Participants Who Were Administered the Study Drug Correctly | 10 Participants |
Primary
Number of Participants With One or More Adverse Events Related to Study Drug
Time frame: Day of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregabalin 300mg | Number of Participants With One or More Adverse Events Related to Study Drug | 6 Participants |
Primary
Respondent Reported Usability of Instruments
Number of patients able to complete 30 day post op questionnaire
Time frame: 30 days post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregabalin 300mg | Respondent Reported Usability of Instruments | 5 Participants |
Secondary
Amount of Opioid Use
Total amount of opioid used for any indication at several time points, in oral morphine equivalents. This is the sum for all patients.
Time frame: Up to 1 year post-op
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin 300mg | Amount of Opioid Use | 90 oral morphine equivalents |
Secondary
Early Post-op Opioid Needs
Number of patients with a verified prescription for narcotic medication within the first 30 post-operative days.
Time frame: First 30 post-operative days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregabalin 300mg | Early Post-op Opioid Needs | 1 Participants |
Secondary
Early Post-op Stent Related Symptoms
Ureteral Stent Related Symptom Questionnaire (USSQ) score, sum of urinary index score, pain index score, and general health index score. Minimum is 24. Maximum is 162. Higher scores indicate a worse outcome.
Time frame: Post-op day 3
Population: Those who completed the questionnaire
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pregabalin 300mg | Early Post-op Stent Related Symptoms | 88 score on a scale |
Secondary
Opioid Use
Number of patients stating that they had used opioids on any survey.
Time frame: Up to 1 year post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pregabalin 300mg | Opioid Use | 1 Participants |
Secondary
Patient Satisfaction
Score on standardized evaluation of patient satisfaction at 7-days post-op. This was on a scale from 1) very dissatisfied to 5) very satisfied. Higher scores are better.
Time frame: First 30 post-operative days
Population: Respondents to the survey
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pregabalin 300mg | Patient Satisfaction | 3.5 score on a scale |
Secondary
Unplanned Healthcare Contacts
Number of unplanned contacts between the patient and the healthcare system. This is the total for all patients.
Time frame: First 30 post-operative days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregabalin 300mg | Unplanned Healthcare Contacts | 2 visits |