Trial Outcomes & Findings for Effects of Perioperative B&O Suppositories on Post-op Pain and Morphine Use After Laparoscopic Prostatectomy (NCT NCT00863928)

NCT ID: NCT00863928

Last Updated: 2019-04-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 135 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2019-04-23

Participant Flow

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

Participant milestones

Measure	Control no intervention	B & O Suppository belladonna 16.2 mg and opium 60 mg suppository
Overall Study STARTED	94	41
Overall Study COMPLETED	58	41
Overall Study NOT COMPLETED	36	0

Reasons for withdrawal

Measure	Control no intervention	B & O Suppository belladonna 16.2 mg and opium 60 mg suppository
Overall Study Protocol Violation	26	0
Overall Study Withdrawal by Subject	3	0
Overall Study surgery cancellation	4	0
Overall Study medication allergy	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control n=94 Participants no intervention	B & O Suppository n=41 Participants belladonna 16.2 mg and opium 60 mg suppository	Total n=135 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Age, Categorical Between 18 and 65 years	48 Participants n=113 Participants	20 Participants n=163 Participants	68 Participants n=160 Participants
Age, Categorical >=65 years	46 Participants n=113 Participants	21 Participants n=163 Participants	67 Participants n=160 Participants
Age, Continuous	61.1 years STANDARD_DEVIATION 6.86 • n=113 Participants	62.7 years STANDARD_DEVIATION 7 • n=163 Participants	61.7 years STANDARD_DEVIATION 7 • n=160 Participants
Sex: Female, Male Female	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Sex: Female, Male Male	94 Participants n=113 Participants	41 Participants n=163 Participants	135 Participants n=160 Participants
Region of Enrollment United States	94 participants n=113 Participants	41 participants n=163 Participants	135 participants n=160 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=94 Participants no intervention	B & O Suppository n=41 Participants belladonna 16.2 mg and opium 60 mg suppository
Pain Assessment by Visual Analog Scale at Rest	19.08 millimeters Standard Deviation 18	13.84 millimeters Standard Deviation 9

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B & O Suppository

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kathryn Dahl, RN

Virginia Mason Medical Center

Phone: 206-341-0578

Email: kathryn.dahl@vmmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place