Pain
Conditions
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.
Detailed 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.
Interventions
DRUGbelladonna 16.2 mg and opium 60 mg suppository
belladonna 16.2 mg and opium 60 mg suppository
Sponsors
Virginia Mason Hospital/Medical Center
Benaroya Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Assessment by Visual Analog Scale at Rest | 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. |
Countries
United States
Participant flow
Recruitment details
November 1, 2008 through July 30, 2009. Subjects recruited at medical center
Participants by arm
| Arm | Count |
|---|---|
| Control no intervention | 94 |
| B & O Suppository belladonna 16.2 mg and opium 60 mg suppository | 41 |
| Total | 135 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | medication allergy | 3 | 0 |
| Overall Study | Protocol Violation | 26 | 0 |
| Overall Study | surgery cancellation | 4 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | B & O Suppository | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 46 Participants | 67 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 48 Participants | 68 Participants |
| Age, Continuous | 62.7 years STANDARD_DEVIATION 7 | 61.1 years STANDARD_DEVIATION 6.86 | 61.7 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 41 participants | 94 participants | 135 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 41 Participants | 94 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 41 |
| serious Total, serious adverse events | 0 / 58 | 0 / 41 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Pain Assessment by Visual Analog Scale at Rest | 19.08 millimeters | Standard Deviation 18 |
| B & O Suppository | Pain Assessment by Visual Analog Scale at Rest | 13.84 millimeters | Standard Deviation 9 |