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

Benaroya Research Institute135 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

135

Conditions

Pain

Interventions

belladonna 16.2 mg and opium 60 mg suppositoryDRUG

belladonna 16.2 mg and opium 60 mg suppository

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Virginia Mason Medical Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

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.

Time frame: 24 hours

Data from ClinicalTrials.gov

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