SurgerySPASMSNCT02291042
Effect of an Anti-spasmodic Suppository to Improve Comfort After Urologic Surgery
A study testing B+O Suppository in people with Surgery, run by Southern New Hampshire Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- B+O Suppository
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients from one urology practice schedule for elective uteroscopy.
Who cannot join
- Patients with pre-operative indwelling catheter or urinary stent.
- Patients who report any allergy to belladonna or opium.
About this study
Official title: Pre-operative Administration of a Muscarinic Antagonist for Elective Cystoscopy Patients
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.
Read the 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
- Being tested
- B+O Suppository
- Keywords
- Bladder, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B+O SuppositoryDrug
Also called Belladona and opium; B+O Supprettes
| Study group | Role | What they receive |
|---|---|---|
| Suppository | Experimental | 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. Receives: Drug: B+O Suppository |
| Control | No intervention | Patients will be provided with routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in mean bladder comfort (baseline at PACU admission to PACU discharge) between experimental and control groups
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.
Measured: Length of postoperative stay from admission to PACU to discharge from PACU an expected average of 2 hours
Secondary outcomes (1)
Duration of PACU length of stay
The time in minutes of the PACU length of stay
Measured: Time from admission to PACU to discharge from PACU an expected average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern New Hampshire Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan J Fetzer, PHD RN, Principal investigator, Southern New Hampshire Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291042
- Sponsor's protocol ID
- 2014-05
- Acronym
- SPASMS
- Status last verified
- Mar 2017
- First submitted
- 13 Oct 2014
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20974030Scavonetto 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.
PubMed 23783051
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Administration of a Muscarinic Antagonist for Elective Cystoscopy Patients
- ClinicalTrials.gov ID
- NCT02291042
- Acronym / sponsor ID
- SPASMS / 2014-05
- Conditions
- Surgery
- Keywords
- Bladder, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Southern New Hampshire Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suppository | Experimental | Drug: B+O SuppositoryPatients 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. |
| Control | No intervention | –Patients will be provided with routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients from one urology practice schedule for elective uteroscopy.
Key exclusion criteria (2 listed)
- Patients with pre-operative indwelling catheter or urinary stent.
- Patients who report any allergy to belladonna or opium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B+O SuppositoryAlso: Belladona and opium; B+O Supprettes | Drug | Suppository |
Primary outcome
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.
1 secondary outcome
Duration of PACU length of stay
Time frame: Time from admission to PACU to discharge from PACU an expected average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Background: PubMed 20974030Lukasewycz 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.
- Background: PubMed 23783051Scavonetto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan J Fetzer, PHD RN principal investigator
Southern New Hampshire Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing B+O Suppository in people with Surgery, run by Southern New Hampshire Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02291042, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.