Overview

This trial is active, not recruiting.

Condition vaginal surgery
Treatments belladonna and opium suppositories, placebo suppositories
Phase phase 4
Sponsor Mayo Clinic
Start date January 2011
End date December 2013
Trial size 90 participants
Trial identifier NCT01150474, 09-008045

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Belladonna and morphine suppositories.
belladonna and opium suppositories
Belladonna and morphine 15/7.5 mg suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
(Placebo Comparator)
Placebo suppositories.
placebo suppositories
Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.

Primary Outcomes

Measure
Pain at Hour 4
time frame: 4 hours following surgery
Pain at Hour 12
time frame: 12 hours after surgery.
Pain at Hour 20
time frame: 20 hours after surgery.

Secondary Outcomes

Measure
Evaluation of ancillary intravenous and oral narcotic use.
time frame: for 24 hours following surgery
Nausea and vomiting
time frame: for 24 hours after surgery
Urinary retention and constipation
time frame: for up to one week following surgery.
Satisfaction with pain relief.
time frame: 24 hours following surgery.

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Scheduled for elective vaginal surgery requiring general anesthesia at the Mayo Clinic Hospital. Exclusion Criteria: - 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.

Additional Information

Official title Randomized Clinical Trial of Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
Principal investigator Rosanne Kho, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Mayo Clinic.