Clinical trial NCT04122196: Perioperative Pregabalin in Ureteroscopy
Official title: Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Ureteral Stent Symptoms After Ureteroscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Kidney Stone
Pain, Postoperative
Addiction
Opioid Use
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, placebo-controlled, double-blinded study examining the use of perioperative pregabalin in ureteroscopy with stent placement. Ureteroscopy is typically performed for kidney or ureteral stones, but may be performed for other reasons such as for the diagnosis and possible treatment of certain kinds of cancers. As part of the same surgery, a ureteral stent is often placed. The surgery and the stent can cause discomfort, and patients may receive narcotic pain medicine. In other surgeries, a single dose of pregabalin, around one hour before surgery has been shown to decrease the need for pain medication after the surgery. This work will test whether this is true in ureteroscopy by giving eligible patients who agree to participate either pregabalin or a placebo shortly before surgery then examining how much pain medication they use after surgery. A placebo is an inactive medication. Neither the study participant nor the study staff will know who received pregabalin and who received placebo until after the study is over. For completing surveys, patients will receive compensation for their time in the form of gift certificates.

Detailed description: The prevalence of urolithiasis is greater than 8% and increasing in the United States. For those who require surgery, ureteroscopic treatment is common, representing \>120,000 procedures yearly in the United States. This does not include ureteroscopy for other, including diagnosis of structural anomaly and diagnosis and management of ureteral and renal pelvic tumors. Frequently, a ureteral stent is placed intraoperatively. There is post-operative pain in around 80% of patients, and 12% of those undergoing ureteroscopy will have an emergency department visit in the first 30 post-operative days, typically for stent related symptoms or post procedural pain. Aside from the short-term repercussions of ureteroscopy with stent placement there are long-term issues related to pain and the treatment thereof. Recent evidence suggests that approximately 6% of opioid naïve patients who undergo ureteroscopy will become new persistent opioid users.

A single perioperative dose of pregabalin has been shown in many surgical contexts to have analgesic, anxiolytic, and opioid sparing effects. A common regimen employed in the literature is a single preoperative dose of 300mg PO pregabalin 1hr before induction of anesthesia. Pregabalin is a well-tolerated gabapentinoid medication with temporary cognition/coordination changes being the most common side effects. There is currently no standard of care for the use of perioperative gabapentinoid medication in ureteroscopy. A pilot was performed looking at such use that demonstrated the safety of this use and the feasibility of studying this at our institution.

In this work, the efficacy and safety of perioperative pregabalin in ureteroscopy with stent placement will be evaluated by executing a prospective, double blind, randomized, placebo-controlled trial for the use of perioperative pregabalin in the management of post-ureteroscopy symptoms, with the hypothesis that this treatment is safe and efficacious. Emphasis will be placed on patient-centered outcomes, especially those related to opioid sparing effects, mainly within the first 30 days after the surgery and extending out to one year.

The study will be powered with an 80% probability to detect a 10% difference in the primary outcomes. It will also assume a loss to follow up rate of 50%. This will require approximately 200 total subjects with a planned 1:1 placebo to active treatment enrollment ratio. The necessary enrollment can be accomplished in 11 months, allowing for 30 days of follow up within the funding period.

The final goal of this project will be at least one paper in a top urology journal. This will contribute to the literature by helping to inform urologists and anesthesiologists on the efficacy and safety of perioperative pregabalin for ureteroscopy with stent placement and will provide data regarding opioid sparing management after ureteroscopy. Opioid related issues abound nationwide and are evident in Missouri. This study has the potential to influence opioid use both in this state and nationwide as it relates to this frequently performed procedure.

Eligibility criteria: Subject Inclusion:

* Age \>= 18 years
* Subject Population Undergoing elective ureteroscopy with stent placement at University of Missouri Hospital and affiliated facilities

Subject Exclusion:

* Renal insufficiency (eGFR \< 60 mL/minute/1.73 m2)
* Chronic indwelling ureteral stent (\>30 days in the previous year)
* Chronic opioid use
* History of opioid abuse
* Chronic gabapentinoid use
* History of gabapentinoid abuse
* Plan for inpatient hospitalization
* Pregnancy
* Inability of the patient to consent for themselves in English
* Allergy to gabapentinoid
* Liver failure or hepatic dysfunction

Primary outcomes:
measure: Visual Analog Scale of Pain Score
timeFrame: 1 hour after arrival to post anesthesia care unit
Secondary outcomes:
measure: Oral Morphine Equivalents of Opioids Prescribed
timeFrame: Within the first 30 days post-operation
measure: Proportion of Patients With Narcotic Prescription
timeFrame: Within the first 30 days post-operation
measure: Number of Unplanned Healthcare Interactions
timeFrame: Within the first 30 days post-operation
measure: Number of Serious Adverse Events
timeFrame: Within the first 30 days post-operation
measure: Proportion of Patients Reporting Nausea or Vomiting
timeFrame: 1 hour after arrival to post anesthesia care unit
measure: Watson Clock Drawing Test Score
timeFrame: 1 hour after arrival to post anesthesia care unit
Other outcomes:
measure: In-facility Oral Morphine Equivalents
timeFrame: Day of surgery
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: Assistant Professor
name: Katie Murray, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahles TA, Ruckdeschel JC, Blanchard EB. Cancer-related pain--II. Assessment with visual analogue scales. J Psychosom Res. 1984;28(2):121-4. doi: 10.1016/0022-3999(84)90004-7.
citation: Watson YI, Arfken CL, Birge SJ. Clock completion: an objective screening test for dementia. J Am Geriatr Soc. 1993 Nov;41(11):1235-40. doi: 10.1111/j.1532-5415.1993.tb07308.x.