Vaginal SurgeryPhase 4NCT01150474
Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
A Phase 4 study testing Belladonna and Opium Suppositories in people with Vaginal Surgery, run by Kristina A. Butler at 1 site in United States.
Trial summary
Our primary aim is to determine whether the routine use of belladonna and morphine suppositories will improve pain control following vaginal surgery. Treatment will begin immediately following surgery and every 8 hours for 16 hours. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Surgery
- What is being tested?
- Belladonna and Opium Suppositories
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective vaginal surgery requiring general anesthesia at the Mayo Clinic Hospital. This would include a vaginal hysterectomy with culdoplasty or post-hysterectomy prolapse repair, including culdoplasty with or without anterior/posterior repair.
Who cannot join
- Participation in another trial using an investigational product.
- Pregnancy.
- Scheduled for a non-vaginal surgical procedure.
- Scheduled for a robotic hysterectomy.
- Scheduled to have combined surgeries (vaginal surgery plus another non-vaginal surgery).
- There is a known hypersensitivity to belladonna and/or opium.
Show all 10Show fewer
- Contraindication to narcotic use.
- Chronic pain with preoperative pain score greater than 4 out of 10 points.
- Clinically significant substance abuse.
- Mental condition that may impair the ability to provide study assessments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
Our primary aim is to determine whether the routine use of belladonna and morphine suppositories will improve pain control following vaginal surgery. Treatment will begin immediately following surgery and every 8 hours for 16 hours.
Read the detailed description
Minimizing postoperative pain is vital to a successful surgical recovery. Inadequate pain control may result in nausea, vomiting, an extended hospital stay, and reduced patient satisfaction. Oral and parenteral narcotics are commonly used for pain relief and their use may exacerbate the incidence of sedation, nausea, and vomiting; ultimately delaying convalescence. Previous studies have demonstrated that rectal analgesia following surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium suppositories are routinely prescribed at our institution and their efficacy has not been confirmed.
A prospective, randomized, double-blind, placebo-controlled trial will be undertaken using belladonna and opium rectal suppositories following vaginal surgery. Treatment will begin immediately following surgery and continue every 8 hours for a total of 3 doses.
- Conditions
- Vaginal Surgery
- Being tested
- Belladonna and Opium Suppositories, Placebo Suppositories
- Keywords
- Belladonna, Morphine, Suppositories, Vaginal, Surgery, Postoperative, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belladonna and Opium SuppositoriesDrug
Also called B & O Supprettes
Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Placebo SuppositoriesDrug
Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Belladonna and Opium Suppositories | Experimental | Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. Receives: Drug: Belladonna and Opium Suppositories |
| Placebo Suppositories | Placebo comparator | Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. Receives: Drug: Placebo Suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at Hour 4
Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
Measured: 4 hours following surgery
Secondary outcomes (8)
Pain at Hour 12
Pain at 12 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
Measured: 12 hours after surgery.
Pain at Hour 20
Pain at 20 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
Measured: 20 hours after surgery.
Narcotic Rescue Medication
Use of all ancillary narcotic medications was taken from the medical record.
Measured: For 24 hours following surgery
Number of Subjects With Nausea
This information was taken from the medical record.
Measured: Approximately 12 hours after surgery
Number of Subjects With Vomiting
This information was taken from the medical record.
Measured: Within 20 hours of surgery
Number of Times Antiemetic Rescue Medication Was Used
Measured: First 24 hours after surgery
Number of Subjects Who Used Antiemetic Rescue Medications
Measured: First 24 hours after surgery
Satisfaction With Pain Relief
Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being "very dissatisfied," and 10 being "very satisfied."
Measured: Approximately 24 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaginal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kristina A. Butler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kristina A. Butler, Mayo Clinic
- Investigators
- Kristina Butler, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150474
- Sponsor's protocol ID
- 09-008045
- Status last verified
- Dec 2014
- First submitted
- 23 Jun 2010
- Last updated
- 7 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
- ClinicalTrials.gov ID
- NCT01150474
- Acronym / sponsor ID
- 09-008045
- Conditions
- Vaginal Surgery
- Keywords
- Belladonna, Morphine, Suppositories, Vaginal, Surgery, Postoperative, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Kristina A. ButlerUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jun 2010 (estimated)
- Results
- Posted 7 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Our primary aim is to determine whether the routine use of belladonna and morphine suppositories will improve pain control following vaginal surgery. Treatment will begin immediately following surgery and every 8 hours for 16 hours.
Detailed description
Minimizing postoperative pain is vital to a successful surgical recovery. Inadequate pain control may result in nausea, vomiting, an extended hospital stay, and reduced patient satisfaction. Oral and parenteral narcotics are commonly used for pain relief and their use may exacerbate the incidence of sedation, nausea, and vomiting; ultimately delaying convalescence. Previous studies have demonstrated that rectal analgesia following surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium suppositories are routinely prescribed at our institution and their efficacy has not been confirmed.
A prospective, randomized, double-blind, placebo-controlled trial will be undertaken using belladonna and opium rectal suppositories following vaginal surgery. Treatment will begin immediately following surgery and continue every 8 hours for a total of 3 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Belladonna and Opium Suppositories | Experimental | Drug: Belladonna and Opium SuppositoriesBelladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. |
| Placebo Suppositories | Placebo comparator | Drug: Placebo SuppositoriesPlacebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for elective vaginal surgery requiring general anesthesia at the Mayo Clinic Hospital. This would include a vaginal hysterectomy with culdoplasty or post-hysterectomy prolapse repair, including culdoplasty with or without anterior/posterior repair.
Key exclusion criteria (10 listed)
- Participation in another trial using an investigational product.
- Pregnancy.
- Scheduled for a non-vaginal surgical procedure.
- Scheduled for a robotic hysterectomy.
- Scheduled to have combined surgeries (vaginal surgery plus another non-vaginal surgery).
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 |
|---|---|---|
| Belladonna and Opium SuppositoriesAlso: B & O SupprettesBelladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. | Drug | Belladonna and Opium Suppositories |
| Placebo SuppositoriesPlacebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. | Drug | Placebo Suppositories |
Primary outcome
Pain at Hour 4
Time frame: 4 hours following surgery
Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
8 secondary outcomes
Pain at Hour 12
Time frame: 12 hours after surgery.
Pain at Hour 20
Time frame: 20 hours after surgery.
Narcotic Rescue Medication
Time frame: For 24 hours following surgery
Number of Subjects With Nausea
Time frame: Approximately 12 hours after surgery
Number of Subjects With Vomiting
Time frame: Within 20 hours of surgery
Number of Times Antiemetic Rescue Medication Was Used
Time frame: First 24 hours after surgery
Number of Subjects Who Used Antiemetic Rescue Medications
Time frame: First 24 hours after surgery
Satisfaction With Pain Relief
Time frame: Approximately 24 hours following surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Surgery
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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.
Kristina Butler, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Belladonna and Opium Suppositories in people with Vaginal Surgery, run by Kristina A. Butler at 1 site in United States.
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 10 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 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain at Hour 4 (time frame: 4 hours following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2015.