Trial Outcomes & Findings for Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery (NCT NCT01150474)

NCT ID: NCT01150474

Last Updated: 2015-01-07

Results Overview

Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 103 participants
• Primary outcome timeframe: 4 hours following surgery
• Results posted on: 2015-01-07

Participant Flow

Subjects were recruited at the Mayo Clinic in Arizona, United States from January 2011 to April 2013.

Participant milestones

Measure	Belladonna and Opium Suppositories Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Overall Study STARTED	51	52
Overall Study COMPLETED	41	49
Overall Study NOT COMPLETED	10	3

Reasons for withdrawal

Measure	Belladonna and Opium Suppositories Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Overall Study Withdrawal by Subject	5	2
Overall Study Cancer found	1	0
Overall Study Multiple Studies	0	1
Overall Study Rectotomy	1	0
Overall Study Drug did not arrive in time	1	0
Overall Study Drug not administered	1	0
Overall Study Surgery Changed	1	0

Baseline Characteristics

Postoperative Belladonna and Morphine Suppositories in Vaginal Surgery

Baseline characteristics by cohort

Measure	Belladonna and Opium Suppositories n=41 Participants Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 Participants Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Total n=90 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 12 • n=5 Participants	55 years STANDARD_DEVIATION 13 • n=7 Participants	55 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	49 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants	49 participants n=7 Participants	90 participants n=5 Participants
Pelvic Organ Prolapse Prolapse	21 participants n=5 Participants	25 participants n=7 Participants	46 participants n=5 Participants
Pelvic Organ Prolapse No Prolapse	20 participants n=5 Participants	24 participants n=7 Participants	44 participants n=5 Participants
Procedure time	98 minutes STANDARD_DEVIATION 37 • n=5 Participants	96 minutes STANDARD_DEVIATION 38 • n=7 Participants	97 minutes STANDARD_DEVIATION 37 • n=5 Participants
Estimated Blood Loss	180 mL STANDARD_DEVIATION 250 • n=5 Participants	150 mL STANDARD_DEVIATION 110 • n=7 Participants	161 mL STANDARD_DEVIATION 186 • n=5 Participants
Preoperative Pain	0.44 units on a scale STANDARD_DEVIATION 1.25 • n=5 Participants	0.24 units on a scale STANDARD_DEVIATION 0.91 • n=7 Participants	0.3 units on a scale STANDARD_DEVIATION 1.07 • n=5 Participants

PRIMARY outcome

Timeframe: 4 hours following surgery

Pain at 4 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."

Outcome measures

Measure	Belladonna and Opium Suppositories n=41 Participants Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 Participants Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Pain at Hour 4	4.2 units on a scale Standard Deviation 2.4	4.1 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 12 hours after surgery.

Pain at 12 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."

Outcome measures

Measure	Belladonna and Opium Suppositories n=41 Participants Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 Participants Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Pain at Hour 12	3.4 units on a scale Standard Deviation 2.4	3.3 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 20 hours after surgery.

Pain at 20 hours was recorded using a linear analog pain scale, with 0 being "no pain," and 10 being "worst pain imaginable."

Outcome measures

Measure	Belladonna and Opium Suppositories n=41 Participants Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 Participants Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Pain at Hour 20	2.5 units on a scale Standard Deviation 1.9	3.4 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: For 24 hours following surgery

Use of all ancillary narcotic medications was taken from the medical record.

Outcome measures

Measure	Belladonna and Opium Suppositories n=41 Participants Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 Participants Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Narcotic Rescue Medication	57 mg IV morphine equivalents Standard Deviation 38	66 mg IV morphine equivalents Standard Deviation 61

SECONDARY outcome

Timeframe: Approximately 12 hours after surgery

This information was taken from the medical record.

Outcome measures

Measure	Belladonna and Opium Suppositories n=41 Participants Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 Participants Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Number of Subjects With Nausea	14 participants	22 participants

SECONDARY outcome

Timeframe: Within 20 hours of surgery

This information was taken from the medical record.

Outcome measures

Measure	Belladonna and Opium Suppositories n=41 Participants Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 Participants Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Number of Subjects With Vomiting	13 participants	9 participants

SECONDARY outcome

Timeframe: First 24 hours after surgery

Outcome measures

Measure	Belladonna and Opium Suppositories n=41 Participants Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 Participants Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Number of Times Antiemetic Rescue Medication Was Used	1.7 number of times antiemetics used Standard Deviation 1.6	1.6 number of times antiemetics used Standard Deviation 1.5

SECONDARY outcome

Timeframe: First 24 hours after surgery

Outcome measures

Measure	Belladonna and Opium Suppositories n=41 Participants Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 Participants Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Number of Subjects Who Used Antiemetic Rescue Medications	30 participants	33 participants

SECONDARY outcome

Timeframe: Approximately 24 hours following surgery

Patient satisfaction with pain relief was evaluated 24 hours after surgery using a linear analog satisfaction scale, with 0 being "very dissatisfied," and 10 being "very satisfied."

Outcome measures

Measure	Belladonna and Opium Suppositories n=41 Participants Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 Participants Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Satisfaction With Pain Relief	8.2 units on a scale Standard Deviation 2.5	7.9 units on a scale Standard Deviation 2.6

Adverse Events

Belladonna and Opium Suppositories

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo Suppositories

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Belladonna and Opium Suppositories n=41 participants at risk Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 participants at risk Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
General disorders Abdominal Sepsis	2.4% 1/41 • Number of events 1 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	0.00% 0/49 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.

Other adverse events

Measure	Belladonna and Opium Suppositories n=41 participants at risk Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.	Placebo Suppositories n=49 participants at risk Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
Blood and lymphatic system disorders Anemia Postoperative	7.3% 3/41 • Number of events 3 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	0.00% 0/49 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.
Renal and urinary disorders Urinary Retention	51.2% 21/41 • Number of events 21 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	46.9% 23/49 • Number of events 23 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.
Gastrointestinal disorders Postoperative Ileus	2.4% 1/41 • Number of events 1 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	0.00% 0/49 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.
Cardiac disorders Procedural Hypertension	2.4% 1/41 • Number of events 1 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	0.00% 0/49 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.
Skin and subcutaneous tissue disorders Pruritis Generalized	2.4% 1/41 • Number of events 1 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	0.00% 0/49 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.
Cardiac disorders Sinus Tachycardia	2.4% 1/41 • Number of events 1 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	0.00% 0/49 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.
Renal and urinary disorders Urinary Tract Infection	2.4% 1/41 • Number of events 1 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	0.00% 0/49 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.
Respiratory, thoracic and mediastinal disorders Sleep Apnea Syndrome	0.00% 0/41 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	2.0% 1/49 • Number of events 1 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.
Cardiac disorders Procedural Hypotension	2.4% 1/41 • Number of events 1 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	6.1% 3/49 • Number of events 3 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.
Gastrointestinal disorders Constipation	57.1% 20/35 • Number of events 20 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.	58.7% 27/46 • Number of events 27 • Subjects will be followed for 24 hours after surgery, and the research coordinator will assess for adverse events one week after surgery via the electronic medical record.

Additional Information

Dr. Kristina A. Butler

Mayo Clinic

Phone: 480-301-5934

Email: butler.kristina@mayo.edu

Results disclosure agreements

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