NCT01150474

Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

Randomized Clinical Trial of Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Kristina A. Butler · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Belladonna and Opium Suppositories	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.
DRUG	Placebo Suppositories	Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2010-06-25
• Last updated: 2015-01-07
• Results posted: 2015-01-07

Locations

1 site across 1 country: United States