Timing of B and O Suppositories to Help Relieve Post-operative Bladder Spasms
| Status: | Terminated |
|---|---|
| Conditions: | Overactive Bladder |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 2/22/2019 |
| Start Date: | March 2016 |
| End Date: | June 2017 |
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.
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.
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.
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.
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.
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