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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Control Arm

No suppository given

Group Type NO_INTERVENTION

No interventions assigned to this group

B & O suppository

B \& O suppository, belladonna 16.2 mg and opium 60 mg suppository (Paddock Laboratories, Minneapolis, MN)

Group Type EXPERIMENTAL

belladonna 16.2 mg and opium 60 mg suppository

Intervention Type DRUG

belladonna 16.2 mg and opium 60 mg suppository

Interventions

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belladonna 16.2 mg and opium 60 mg suppository

Intervention Type DRUG

Other Intervention Names

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B & O Suppository

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No