The Use of Belladonna and Opium Suppository in the Treatment of Postoperative Stent Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine if preemptive B&O suppository placement will decrease post-operative pain in patients undergoing ureteral stent placement.

Detailed Description
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Purpose: Nephrolithiasis has an incidence of 10-15% in the US with 66% of practicing urologists placing a ureteral stent after each procedure. Ureteral stents are commonly placed to prevent or alleviate ureteral obstruction and ureteral stents are not well tolerated with up to 80% of patients reporting stent discomfort. These symptoms include urinary frequency, urgency, dysuria and incomplete emptying. Patients also frequently report suprapubic pain, hematuria and incontinence. Ureteral stents are placed either alone or in conjunction with other surgeries where ureteral access is obtained. To date, however, there is no convincing data that altering stent characteristics or the use of a single drug dramatically improves stent discomfort for patients. Prior studies on oral therapies including alpha blockers and anti-muscarinics have shown some promise in improving stent comfort, however, they are typically used after the ureteral stent is placed and the patient has recovered from anesthesia. Other studies have shown no difference in stent symptoms in these two classes of drugs. The Belladonna and Opium (B&O) suppository is a potent anti-muscarinic medication with narcotic properties. It frequently is used as a second line drug for patients with severe bladder spasms refractory to first line anti-muscarinic and narcotic medications from an indwelling Foley catheter or ureteral stent. It has shown efficacy for Foley catheter discomfort in patients undergoing robotic prostatectomies, but its use in the perioperative period has not been studied for ureteral stent discomfort. The purpose of this study is to determine if preemptive B&O suppository placement will decrease post-operative pain in patients undergoing ureteral stent placement. Procedures: The study is a randomized double-blind controlled trial comparing the use of a B&O suppository versus placebo suppository for the preemptive treatment of ureteral stent discomfort. 70 subjects will be recruited from the outpatient urologic clinic under the care of a single surgeon with appropriate informed consent. At the time of recruitment, patients will complete a validated AUA symptom score questionnaire in order to establish baseline symptom scores and urinary bother. Patients will be randomized into a treatment arm or a placebo arm. Those randomized to the treatment arm will receive a single B&O suppository, dose-weight calculated, immediately following patient positioning prior to instrumentation. Those randomized to the other arm will receive a single placebo suppository. The suppository will be administered by the circulating operative nurse and the remainder of the surgical team will be blinded to the study drug. Following treatment and stent placement, all patients will receive standard post-operative pain management (hydrocodone/acetaminophen, docusate, and tamsulosin) with usual discharge instructions. Subject Population: Primary study population is patients who will receive ureteroscopy with concurrent placement of a ureteral stent. Primary exclusion criteria include age < 18, neurologic deficits of any kind and non-English speaking patients.

Official Title
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The Use of Belladonna and Opium (B&O) Suppository in the Treatment of Postoperative Stent Pain: A Randomized, Double-Blinded Control Study

Conditions
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Nephrolithiasis

Intervention / Treatment
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* Drug: Belladonna and Opium
* Other: Placebo suppository


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who will receive ureteroscopy with concurrent placement of a ureteral stent. Exclusion Criteria: age < 18, neurologic deficits of any kind non-English speaking patients.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Belladonna and Opium (B&O) suppository<br>A single belladonna and opium suppository, dose-weight calculated, administered immediately following patient positioning prior to instrumentation. The pharmacologically active ingredients that are present in the belladonna extract consist of atropine and scopolamine. Opium is compound drug that is composed of 20 alkaloids. The principle alkaloid that derives the majority of its effect is its morphine content and acts as a narcotic analgesic by increasing the pain threshold or the magnitude of stimulus required to evoke pain. | Drug: Belladonna and Opium<br> <br> * Other names: B&O;|
| Placebo Comparator: Placebo Suppository<br>placebo suppository | Other: Placebo suppository<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Quality of Life Score on Postoperative Day 1 | Global quality of life score as measured by the Ureteral Stent Symptom Questionnaire (USSQ). Scale is 1-7 (Lower score indicating better quality of life compared to higher score). 1 = delighted, 2 = pleased, 3 = mostly satisfied, 4 = mixed feelings (about equally satisfied and dissatisfied), 5 = mostly dissatisfied, 6 = unhappy, 7 = terrible | postoperative day 1 | 
| Global Quality of Life Score on Postoperative 3 | Global quality of life score as measured by the Ureteral Stent Symptom Questionnaire (USSQ). Scale is 1-7 (Lower score indicating better quality of life compared to higher score). 1 = delighted, 2 = pleased, 3 = mostly satisfied, 4 = mixed feelings (about equally satisfied and dissatisfied), 5 = mostly dissatisfied, 6 = unhappy, 7 = terrible | postoperative day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postoperative Complications as a Result of the Use of B&O Suppository | To assess postoperative complications as a result of the use of B&O suppository, including urinary retention. | 14 days post-op | 
| Number of Participants With Unanticipated Postoperative Visits | Number of postoperative unanticipated visits including nursing visits and ED visits | 14 days post-op | 
| Measurement of Post-operative Narcotic Use | Measurement of postoperative opiate use using a questionnaire. We will define success as a reduction in postoperative narcotic use by 10% compared to placebo. | 14 days post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteral stent pain, nephrolithiasis, kidney stone