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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suppository | Experimental | 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. |
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| Control | No Intervention | Patients will be provided with routine care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B+O Suppository | Drug |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Requirements for rescue therapy for pain and urgency | Additional interventions for rescue pharmacology administered postoperatively to relieve pain or urgency | From PACU admission to PACU discharge an expected average of 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan J Fetzer, PHD RN | Southern New Hampshire Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20974030 | Background | Lukasewycz S, Holman M, Kozlowski P, Porter CR, Odom E, Bernards C, Neil N, Corman JM. Does a perioperative belladonna and opium suppository improve postoperative pain following robotic assisted laparoscopic radical prostatectomy? Results of a single institution randomized study. Can J Urol. 2010 Oct;17(5):5377-82. | |
| 23783051 | Background |
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| ID | Term |
|---|---|
| D009892 | Opium |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Scavonetto F, Lamborn DR, McCaffrey JM, Schroeder DR, Gettman MT, Sprung J, Weingarten TN. Prophylactic belladonna suppositories on anesthetic recovery after robotic assisted laparoscopic prostatectomy. Can J Urol. 2013 Jun;20(3):6799-804. |