Effects of Perioperative B&O Suppositories on Post-op Pain and Morphine Use After Laparoscopic Prostatectomy

Study Overview
=================
Brief Summary
-----------------
This study is evaluating the effect of a Belladonna and Opium suppository administered intraoperatively on post operative pain after laparoscopic radical prostatectomy for prostate cancer. This is a blinded randomized study. 50% of patients will receive the suppository, 50% of patients will not. Neither you or your surgeon will know which group you are in.

Detailed Description
-----------------
All patients undergoing LRP at Virginia Mason Medical Center between November 1, 2008 and July 30, 2009 were offered the opportunity to participate in a randomized double blind clinical trial. Operating surgeons were blinded to suppository placement which was administered after induction of anesthesia. All patients underwent a standardized anesthesia regimen. Post-operative pain was assessed by a visual analog scale (VAS) and post-operative narcotic use was calculated in intravenous morphine equivalents.

Official Title
-----------------
Effects of Perioperative Belladonna and Opium Suppositories on Postoperative Pain and Morphine Consumption on Patients After Robotic Assisted Laparoscopic Radical Prostatectomy

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: belladonna 16.2 mg and opium 60 mg suppository


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for laparoscopic radical prostatectomy at Virginia Mason, who do not have chronic pain or allergies to opioid analgesics are eligible for this study. Exclusion Criteria: Women are excluded due to the absence of a prostate. Children are excluded due to the absence of prostate cancer in this group. Patients meeting any of the following will not be eligible for the study: Patients at risk for complications from anticholinergic agents including those with a history of glaucoma, bronchial asthma, convulsive disorder, or high risk for delirium History of previous allergies or adverse reactions to belladonna and opium and/or opioid analgesics History of chronic pain or chronic use of opioid and nonopioid analgesics History of alcohol or opioid dependency/abuse within last three months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Arm<br>No suppository given | |
| Experimental: B & O suppository<br>B & O suppository, belladonna 16.2 mg and opium 60 mg suppository (Paddock Laboratories, Minneapolis, MN) | Drug: belladonna 16.2 mg and opium 60 mg suppository<br>* belladonna 16.2 mg and opium 60 mg suppository<br>* Other names: B & O Suppository;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment by Visual Analog Scale at Rest | The Pain Assessment by Visual Analog Scale (VAS) consists of 100 millimeter (mm) horizontal line with two endpoints 1-100, labeled no pain and worst possible pain. No pain is the minimum value and worst possible pain is the maximum value. Minimum value or No Pain is considered a better outcome. | 24 hours |