Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vaginal Surgery

Intervention / Treatment
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* Drug: Belladonna and Opium Suppositories
* Drug: Placebo Suppositories


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Belladonna and Opium Suppositories<br>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<br>* 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.<br>* Other names: B & O Supprettes;|
| Placebo Comparator: Placebo Suppositories<br>Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses. | Drug: Placebo Suppositories<br>* Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Belladonna, Morphine, Suppositories, Vaginal, Surgery, Postoperative, Pain