Effect of an Anti-spasmodic Suppository to Improve Comfort After Urologic Surgery

Study Overview
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Brief Summary
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This study evaluates the ability of a belladonna and opium suppository given prior to surgery to improve bladder comfort after surgery for patients who are having elective ureteroscopy surgery.

Detailed Description
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Belladonna and opium suppositories are administered postoperatively to relieve bladder discomfort usually caused by bladder spasms. The onset of action of the suppository is 30-60 minutes. Bladder spasms are more likely to occur following uteroscopy procedures. The spasms result in a felt desire to void, even when there is no urine in the bladder. The spasms can produce pain or a sense of severe urgency. By administering a belladonna and opium suppository at the beginning of surgery, it is hoped that there will be a decrease in the incidence of bladder spasms, increased comfort and less need for additional medications.

Official Title
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Pre-operative Administration of a Muscarinic Antagonist for Elective Cystoscopy Patients

Conditions
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Surgery

Intervention / Treatment
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* Drug: B+O Suppository


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from one urology practice schedule for elective uteroscopy. Exclusion Criteria: Patients with pre-operative indwelling catheter or urinary stent. Patients who report any allergy to belladonna or opium.

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suppository<br>Patients will receive a single antispasmodic muscarinic suppository after induction of anesthesia but before insertion of urological scope for surgery. The suppository is composed of Belladonna (16.2 mg) and Opium (30 mg) in a water soluble base manufactured as Belladonna and Opium Supprettes. | Drug: B+O Suppository<br> <br> * Other names: Belladona and opium; B+O Supprettes;|
| No Intervention: Control<br>Patients will be provided with routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in mean bladder comfort (baseline at PACU admission to PACU discharge) between experimental and control groups | Bladder comfort is defined as bladder pain and bladder urgency. Bladder pain is measured on a 0-10 verbal analog scale with 0 = no pain and 10 = most pain possible. Bladder urgency is measured by a 0 - 4 scale with 0 = no desire to void, 1 = awarenes of need to void which can be delayed at least 30 minutes, 2 = moderate urgency than can be delayed for no more than 15 minutes, 3 = severe urgency that can be delayed for no more than 5 minutes, 4 = must void now. Pain and urgency are reported by the patient with or without questioning by the nurse. | Length of postoperative stay from admission to PACU to discharge from PACU an expected average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of PACU length of stay | The time in minutes of the PACU length of stay | Time from admission to PACU to discharge from PACU an expected average of 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder, Surgery