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

Pain Clinical Trial

Official title:

Effects of Perioperative Belladonna and Opium Suppositories on Postoperative Pain and Morphine Consumption on Patients After Robotic Assisted Laparoscopic Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863928
• Other study ID #: IRB08100
• Secondary ID: IRB08100
• Status: Completed
• Phase: N/A
• Start date: October 2008
• Est. completion date: July 2009

Study information

• Verified date: April 2019
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• belladonna 16.2 mg and opium 60 mg suppository
belladonna 16.2 mg and opium 60 mg suppository

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Benaroya Research Institute	Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24 hours