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Clinical Trials/NCT02291042
NCT02291042
Completed
N/A

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

Southern New Hampshire Medical Center0 sites50 target enrollmentOctober 2015
ConditionsSurgery
InterventionsB+O Suppository

Overview

Phase
N/A
Intervention
B+O Suppository
Conditions
Surgery
Sponsor
Southern New Hampshire Medical Center
Enrollment
50
Primary Endpoint
Difference in mean bladder comfort (baseline at PACU admission to PACU discharge) between experimental and control groups
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
March 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Southern New Hampshire Medical Center
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

Suppository

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.

Intervention: B+O Suppository

Outcomes

Primary Outcomes

Difference in mean bladder comfort (baseline at PACU admission to PACU discharge) between experimental and control groups

Time Frame: Length of postoperative stay from admission to PACU to discharge from PACU an expected average of 2 hours

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.

Secondary Outcomes

  • Duration of PACU length of stay(Time from admission to PACU to discharge from PACU an expected average of 2 hours)

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