Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms

Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms and Urinary Discomfort in Patients Undergoing Lithotripsy

Ureteroscopy is a common procedure in Urology that patients undergo daily to deal with a variety of ailments. These procedures often require that the bladder be filled and emptied with sterile water or saline several times during the procedure, and often result in the patient receiving a catheter at the end of the procedure. One common side effect is that patients experience bladder spasm or discomfort for a period of time after these procedures. Belladonna and Opium (B and O) suppositories and PO Oxybutynin are often given in the post-operative setting to relieve these symptoms.

The principle objectives of this study are:

1. To determine if the addition of a B and O supprette suppository at the end of cystoscopic/ureteroscopic procedures reduces the incidence of bladder spasms and urinary discomfort that patients experience in the post-operative setting.
2. To determine if using peri-operative B and O supprette suppositories reduces the need for pos-operative oral Ditropan and use of narcotic pain medications.

Study Overview

• Status: Terminated
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Belladonna and Opium Suppository; Procedure: Rectal Exam

Detailed Description

The patients will be divided into three research arms. Patients will be randomly selected for one of the groups using a random number generator between 1 and 3. There will be a "Control Group" which will receive a rectal exam while still in the operating room in the lithotomy position after the procedure. There will be a "Postoperative OR" group which will receive a B and O suppository while still in the operating room in the lithotomy position after the procedure. Finally, there will be a "Preoperative OR" group which will receive a B and O suppository after the induction of anesthesia prior to beginning the urologic procedure in the lithotomy position. The "Control Group" will receive a rectal exam in the operating room after the procedure but before extubation to simulate the effects of suppository administration so that the investigators know that any effects are due to the medication and not to the placement of the suppository itself. Those patients in the "control group" may receive a B and O suppository as part of standard procedure in the post-operative period if these individuals experience any bladder spasms and wish to have this as a treatment. This administration will be at the discretion of the operating surgeon as it is in standard cases. Patients may also receive Ditropan in the post-operative setting, which is part of the standard procedure for treating bladder spasms following urologic procedures. Patients in the postoperative and preoperative OR groups will be offered Ditropan for any bladder spasms in the post-operative setting to control symptoms, which is part of the normal standard of care for anyone who has already received a B and O suppository with inadequate control of symptoms. All patients will be treated with a normal post-operative pain regimen which may include narcotics. This will be at the discretion of the treating physician.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing lithotripsy procedure at GW Hospital

Exclusion Criteria:

• The criteria for exclusion for those patients who agree to participate in the study will be patients with glaucoma, severe hepatic or renal disease, bronchial asthma, respiratory depression at the time of administration, convulsive disorders, allergy to anti-muscarinics or opiates, history of anorectal surgery, pre-operative use of antimuscarinics, chronic pain, chronic use of analgesics, or a history of alcohol or opioid dependency.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-operative Suppository; A B&O Suppository will be placed in the patient's rectum after the induction of anesthesia, but before the surgery.	Drug: Belladonna and Opium Suppository
Active Comparator: Post-operative Suppository; A B&O Suppository will be placed in the patient's rectum while still under anesthesia, but after the surgery.	Drug: Belladonna and Opium Suppository
Placebo Comparator: Rectal Exam; Patient's will be given a rectal exam after the procedure but while still under anesthesia to serve as a placebo.	Procedure: Rectal Exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Morphine Equivalent Dose	No results collected on the post-operative morphine equivalent dose	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Operative Pain	Patients will be asked to fill out a short questionnaire with the faces scale to grade their pain on a scale of 1-10	24 hours

Collaborators and Investigators

• Sponsor: Campbell Grant
• Investigators: Principal Investigator: Patrick Mufarrij, George Washington University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 17, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Belladonna and Opium Suppositories
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive
• Other Study ID Numbers: GW051534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No