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

Southern New Hampshire Medical Center

Status: Completed

Conditions: Surgery

Treatments: Drug: B+O Suppository

Study type: Interventional

Funder types: Other

Identifiers

NCT02291042

2014-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Suppository

Experimental group

Description:

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.

Treatment:

Drug: B+O Suppository

Control

No Intervention group

Description:

Patients will be provided with routine care.