Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

Completed · Phase 4 · Has a placebo group

Conditions studied: Vaginal Surgery

In brief

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.

Key facts

Study ID

NCT01150474

Run by

Kristina A. Butler

People needed

103

Starts

2011-01-01

Expected to finish

2013-12-01

Last updated by the study team

2015-01-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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