Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
This trial is active, not recruiting.
|Treatments||belladonna and opium suppositories, placebo suppositories|
|Start date||January 2011|
|End date||December 2013|
|Trial size||90 participants|
|Trial identifier||NCT01150474, 09-008045|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
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.
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.
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.
|Official title||Randomized Clinical Trial of Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery|
|Principal investigator||Rosanne Kho, M.D.|
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