Perioperative Pregabalin in Ureteroscopy: a Pilot
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|ClinicalTrials.gov Identifier: NCT03927781|
Recruitment Status : Active, not recruiting
First Posted : April 25, 2019
Last Update Posted : November 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nephrolithiasis Urolithiasis Perioperative/Postoperative Complications Pain, Postoperative Pain, Acute Anesthesia Urologic Diseases Anesthesia Morbidity||Drug: Pregabalin 300mg||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All participants will receive 300mg PO pregabalin one hour before procedure start|
|Masking:||None (Open Label)|
|Masking Description:||There will be no blinding for this pilot|
|Official Title:||Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Pain After Ureteroscopy With Stent Placement: a Pilot|
|Actual Study Start Date :||April 1, 2019|
|Actual Primary Completion Date :||October 15, 2019|
|Estimated Study Completion Date :||October 15, 2020|
Experimental: Pregabalin 300mg
300mg pregabalin, PO, once, 1 hr before surgery
Drug: Pregabalin 300mg
One 300mg capsule will be administered PO 1 hour before surgery
- Adverse events related to study drug [ Time Frame: Day of surgery ]Adverse events related to study drug, mainly in post anesthesia care unit
- Administration of study drug [ Time Frame: Day of surgery ]Verified correct administration of study drug
- Respondent reported usability of instruments [ Time Frame: 30 days post-op ]Questionnaire respondent self-report of usability of instrument
- Early post-op stent related symptoms [ Time Frame: Post-op day 3 ]
Ureteral Stent Related Symptom Questionnaire (USSQ) score.
Subscores include the following:
Urinary Index Score (11-57). Higher scores indicates worse outcomes. Pain Index Score (6-30) Higher scores indicates worse outcomes. General Health Index Score (6-30). Higher scores indicates worse outcomes. Work Performance Score (3-15). Higher scores indicates worse outcomes. Sexual Matters( 2-10) Higher scores indicates worse outcomes. Additional Problems with the stent in situ (4-17) Higher scores indicates worse outcomes.
Global Quality of life with the stent in situ (1-7). Higher scores indicates worse outcomes.
- Early post-op opioid needs [ Time Frame: First 30 post-operative days ]Monitored prescribing of narcotic pain medication
- Opioid use [ Time Frame: Up to 1 year post-op ]Opioid use for any indication at several time points
- Amount of opioid use [ Time Frame: Up to 1 year post-op ]Amount of opioid used for any indication at several time points, in oral morphine equivalents
- Unplanned healthcare contacts [ Time Frame: First 30 post-operative days ]Number of unplanned contacts between the patient and the healthcare system
- Patient satisfaction [ Time Frame: First 30 post-operative days ]Score on standardized evaluation of patient satisfaction at various time points. There are two questions graded from very dissatisfied to very satisfied regarding pain related satisfaction and overall satisfaction.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927781
|United States, Missouri|
|University of Missouri-Columbia|
|Columbia, Missouri, United States, 65212|
|Principal Investigator:||Katie Murray, DO||Assistant Professor|