N/A
Completed N=135
Effects of Perioperative B&O Suppositories on Post-op Pain and Morphine Use After Laparoscopic Prostatectomy
Source: ClinicalTrials.gov NCT00863928 ↗Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Pain Assessment by Visual Analog Scale at Rest — 19.08; 13.84 millimeters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Assessment by Visual Analog Scale at Rest |
19.08; 13.84 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00863928). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.