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

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Drug: B+O Suppository

• Registration Number: NCT02291042
• Lead Sponsor: Southern New Hampshire Medical Center

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.

Study Timeline

• Study First Submitted: 2014-10-13
• Study First Submitted QC: 2014-11-11
• Study First Posted: 2014-11-14
• Study Start: 2015-10
• Primary Completion: 2016-02
• Study Completion: 2016-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suppository	B+O 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.

Primary Outcome Measures

Name	Time	Method
Difference in mean bladder comfort (baseline at PACU admission to PACU discharge) between experimental and control groups	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 Outcome Measures

Name	Time	Method
Duration of PACU length of stay	Time from admission to PACU to discharge from PACU an expected average of 2 hours	The time in minutes of the PACU length of stay