Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Surgery
• Intervention / Treatment: Drug: Belladonna and Opium Suppositories; Drug: Placebo Suppositories

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.; Other Names: B & O Supprettes
Placebo Comparator: Placebo Suppositories; Placebo 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at Hour 4	Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."	4 hours following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at Hour 12	Pain at 12 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."	12 hours after surgery.
Pain at Hour 20	Pain at 20 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."	20 hours after surgery.
Narcotic Rescue Medication	Use of all ancillary narcotic medications was taken from the medical record.	For 24 hours following surgery
Number of Subjects With Nausea	This information was taken from the medical record.	Approximately 12 hours after surgery
Number of Subjects With Vomiting	This information was taken from the medical record.	Within 20 hours of surgery
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	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."	Approximately 24 hours following surgery

Collaborators and Investigators

• Sponsor: Kristina A. Butler
• Investigators: Principal Investigator: Kristina Butler, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 23, 2010
• First Submitted That Met QC Criteria: June 23, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Estimate): January 7, 2015
• Last Update Submitted That Met QC Criteria: December 23, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Pain; Surgery; Morphine; Postoperative; Vaginal; Belladonna; Suppositories
• Other Study ID Numbers: 09-008045