Randomized Clinical Trial of Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
Overview
- Phase
- Phase 4
- Intervention
- Belladonna and Opium Suppositories
- Conditions
- Vaginal Surgery
- Sponsor
- Kristina A. Butler
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Pain at Hour 4
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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 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.
Investigators
Kristina A. Butler
M.D.
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •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 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.
Arms & Interventions
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.
Intervention: Belladonna and Opium Suppositories
Placebo Suppositories
Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Intervention: Placebo Suppositories
Outcomes
Primary Outcomes
Pain at Hour 4
Time Frame: 4 hours following surgery
Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
Secondary Outcomes
- Number of Times Antiemetic Rescue Medication Was Used(First 24 hours after surgery)
- Number of Subjects Who Used Antiemetic Rescue Medications(First 24 hours after surgery)
- Satisfaction With Pain Relief(Approximately 24 hours following surgery)
- Narcotic Rescue Medication(For 24 hours following surgery)
- Number of Subjects With Nausea(Approximately 12 hours after surgery)
- Pain at Hour 12(12 hours after surgery.)
- Pain at Hour 20(20 hours after surgery.)
- Number of Subjects With Vomiting(Within 20 hours of surgery)