Prostate Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

135

Study ID:

NCT00863928

Recruitment Status:

Completed

Sponsor:

Benaroya Research Institute

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There is 1 Location for this study

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Virginia Mason Medical Center
Seattle Washington, 98101, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

135

Study ID:

NCT00863928

Recruitment Status:

Completed

Sponsor:


Benaroya Research Institute

How clear is this clinincal trial information?

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