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

NCT ID: NCT02291042

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-03-31

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.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

B+O Suppository

Intervention Type: DRUG

Control

Patients will be provided with routine care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

B+O Suppository

Intervention Type: DRUG

Other Intervention Names

Belladona and opium; B+O Supprettes

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern New Hampshire Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan J Fetzer, PHD RN

Role: PRINCIPAL_INVESTIGATOR

Southern New Hampshire Medical Center

References

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.

Reference Type: BACKGROUND

PMID: 20974030 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23783051 (View on PubMed)

Other Identifiers

2014-05

Identifier Type: -

Identifier Source: org_study_id