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| ID | Type | Description | Link |
|---|---|---|---|
| IRB08100 | Other Identifier | Benaroya Research Institute |
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| Name | Class |
|---|---|
| Virginia Mason Hospital/Medical Center | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| belladonna 16.2 mg and opium 60 mg suppository | Drug | belladonna 16.2 mg and opium 60 mg suppository |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| John M Corman, MD | Benaroya Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
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November 1, 2008 through July 30, 2009. Subjects recruited at medical center
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | no intervention |
| FG001 | B & O Suppository | belladonna 16.2 mg and opium 60 mg suppository |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | no intervention |
| BG001 | B & O Suppository | belladonna 16.2 mg and opium 60 mg suppository |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | millimeters | 24 hours |
|
24 hours post-operatively
Sedation, nausea, and pruritis will be assessed by nursing every 1 hour x 4 hours, then every 2 hours by 4, then every 4 hours up to 24 hours post-op
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | no intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn Dahl, RN | Virginia Mason Medical Center | 206-341-0578 | kathryn.dahl@vmmc.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009892 | Opium |
| D013488 | Suppositories |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| surgery cancellation |
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| medication allergy |
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| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | B & O Suppository | belladonna 16.2 mg and opium 60 mg suppository | 0 | 41 | 0 | 41 |
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| D004304 |
| Dosage Forms |
| D004364 | Pharmaceutical Preparations |