Status:
COMPLETED
Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
Lead Sponsor:
Kristina A. Butler
Conditions:
Vaginal Surgery
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01150474
Start Date
January 1 2011
End Date
December 1 2013
Last Update
January 7 2015
Active Locations (1)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054