Conditions: Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 135
Healthy volunteers: no

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.

Arms:
arm 1: No suppository given arm 2: B \& O suppository, belladonna 16.2 mg and opium 60 mg suppository (Paddock Laboratories, Minneapolis, MN)

Interventions: intervention 1: belladonna 16.2 mg and opium 60 mg suppository
Intervention descriptions: intervention 1: belladonna 16.2 mg and opium 60 mg suppository

Protocol document: