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Completed

NCT Number: NCT00863928

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

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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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

belladonna 16.2 mg and opium 60 mg suppository

Drug

belladonna 16.2 mg and opium 60 mg suppository

Other names: B & O Suppository

Primary outcomes

  1. Pain Assessment by Visual Analog Scale at Rest

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Collaborators

  • Virginia Mason Hospital/Medical Center

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 18, 2009
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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