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Completed

NCT Number: NCT02291042

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

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.

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Key information

Conditions

Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

B+O Suppository

Drug

Other names: Belladona and opium; B+O Supprettes

Primary outcomes

  1. 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

  1. Duration of PACU length of stay

    Time frame: 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

Other outcomes

  1. Requirements for rescue therapy for pain and urgency

    Time frame: From PACU admission to PACU discharge an expected average of 2 hours

    Additional interventions for rescue pharmacology administered postoperatively to relieve pain or urgency

Sponsors and collaborators

Lead sponsor

Southern New Hampshire Medical Center

Other

Registry information

Official study title

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

Acronym: SPASMS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 14, 2014
Registry last updated
Mar 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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