Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

Phase 4

Completed

Interventions: Drug: Belladonna and Opium Suppositories
Drug: Placebo Suppositories

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Belladonna and Opium Suppositories	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.
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 Outcome Measures

Name	Time	Method
Pain at Hour 4	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 Outcome Measures

Name	Time	Method
Number of Subjects Who Used Antiemetic Rescue Medications	First 24 hours after surgery
Number of Times Antiemetic Rescue Medication Was Used	First 24 hours after surgery
Satisfaction With Pain Relief	Approximately 24 hours following surgery	Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being "very dissatisfied," and 10 being "very satisfied."
Narcotic Rescue Medication	For 24 hours following surgery	Use of all ancillary narcotic medications was taken from the medical record.
Number of Subjects With Nausea	Approximately 12 hours after surgery	This information was taken from the medical record.
Pain at Hour 12	12 hours after surgery.	Pain at 12 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
Pain at Hour 20	20 hours after surgery.	Pain at 20 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."
Number of Subjects With Vomiting	Within 20 hours of surgery	This information was taken from the medical record.