Clinical trial NCT01150474: Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
Official title: Randomized Clinical Trial of Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaginal Surgery
Keywords: Belladonna
Morphine
Suppositories
Vaginal
Surgery
Postoperative
Pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-06-25
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pain at Hour 4
timeFrame: 4 hours following surgery
Secondary outcomes:
measure: Pain at Hour 12
timeFrame: 12 hours after surgery.
measure: Pain at Hour 20
timeFrame: 20 hours after surgery.
measure: Narcotic Rescue Medication
timeFrame: For 24 hours following surgery
measure: Number of Subjects With Nausea
timeFrame: Approximately 12 hours after surgery
measure: Number of Subjects With Vomiting
timeFrame: Within 20 hours of surgery
measure: Number of Times Antiemetic Rescue Medication Was Used
timeFrame: First 24 hours after surgery
measure: Number of Subjects Who Used Antiemetic Rescue Medications
timeFrame: First 24 hours after surgery
measure: Satisfaction With Pain Relief
timeFrame: Approximately 24 hours following surgery
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Kristina Butler, M.D.
role: PRINCIPAL_INVESTIGATOR
References: