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

NCT00863928 | Completed Results

• 1 other identifier: IRB08100
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Arm

NO INTERVENTION

No suppository given

B & O suppository

EXPERIMENTAL

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

Interventions

belladonna 16.2 mg and opium 60 mg suppository DRUG

belladonna 16.2 mg and opium 60 mg suppository

Also known as: B & O Suppository

B & O suppository

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Virginia Mason Hospital/Medical Center: collaborator

Study Sites (1)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Opium; Suppositories

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Kathryn Dahl, RN
• Organization: Virginia Mason Medical Center

kathryn.dahl@vmmc.org

206-341-0578

Study Officials

• John M Corman, MD

  Benaroya Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2009
• First Posted: March 18, 2009
• Study Start: October 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 23, 2019
• Results First Posted: March 6, 2019

Record last verified: 2019-04

Locations

US (1)