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

• Sponsor: Benaroya Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00863928
• Collaborator: Virginia Mason Hospital/Medical Center (Other)
• Enrollment: 135
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 15.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: belladonna 16.2 mg and opium 60 mg suppository	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 135 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Effects of Perioperative Belladonna and Opium Suppositories on Postoperative Pain and Morphine Consumption on Patients After Robotic Assisted Laparoscopic Radical Prostatectomy
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Arm No suppository given
Experimental: B & O suppository B & O suppository, belladonna 16.2 mg and opium 60 mg suppository (Paddock Laboratories, Minneapolis, MN)	Drug: belladonna 16.2 mg and opium 60 mg suppository; belladonna 16.2 mg and opium 60 mg suppository; Other Names: B & O Suppository

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Mason Medical Center	Seattle	Washington	United States	98101

Sponsors and Collaborators

• Benaroya Research Institute
• Virginia Mason Hospital/Medical Center

Investigators

• Principal Investigator: John M Corman, MD, Benaroya Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Corman, MD, Principal Investigator, Benaroya Research Institute
• ClinicalTrials.gov Identifier: NCT00863928
• Other Study ID Numbers: IRB08100; IRB08100
• First Posted: Mar 18, 2009
• Last Update Posted: Apr 23, 2019
• Last Verified: Apr 1, 2019

Study Results

Participant Flow

Recruitment Details	November 1, 2008 through July 30, 2009. Subjects recruited at medical center

Arm/Group Title	Control	B & O Suppository
Arm/Group Description	no intervention	belladonna 16.2 mg and opium 60 mg suppository
Period Title: Overall Study
STARTED	94	41
COMPLETED	58	41
NOT COMPLETED	36	0

Baseline Characteristics

Arm/Group Title	Control	B & O Suppository	Total
Arm/Group Description	no intervention	belladonna 16.2 mg and opium 60 mg suppository	Total of all reporting groups
Overall Participants	94	41	135
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	48 51.1%	20 48.8%	68 50.4%
>=65 years	46 48.9%	21 51.2%	67 49.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.1 (6.86)	62.7 (7)	61.7 (7)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	94 100%	41 100%	135 100%
Region of Enrollment (participants) [Number]
United States	94 100%	41 100%	135 100%

Outcome Measures

1. Primary Outcome

Title	Pain Assessment by Visual Analog Scale at Rest
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	B & O Suppository
Arm/Group Description	no intervention	belladonna 16.2 mg and opium 60 mg suppository
Measure Participants	94	41
Mean (Standard Deviation) [millimeters]	19.08 (18)	13.84 (9)

Adverse Events

Time Frame	24 hours post-operatively
Adverse Event Reporting Description	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
Arm/Group Title	Control		B & O Suppository
Arm/Group Description	no intervention		belladonna 16.2 mg and opium 60 mg suppository
All Cause Mortality
	Control		B & O Suppository
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control		B & O Suppository
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/41 (0%)
Other (Not Including Serious) Adverse Events
	Control		B & O Suppository
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/58 (0%)		0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.