Trial Outcomes & Findings for Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription (NCT NCT03588910)
NCT ID: NCT03588910
Last Updated: 2021-08-13
Results Overview
During the survey phone call on day 1, participants will be asked to report the total number of oxycodone tablets use since the surgery.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
24 hours post-operative
Results posted on
2021-08-13
Participant Flow
Participant milestones
| Measure |
Number of Oxycodone Tablets Typically Prescribed
Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
Half the Number of Oxycodone Tablets Typically Prescribed
Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
Post Op Day 1 Survey
|
52
|
47
|
|
Overall Study
COMPLETED
|
47
|
45
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
Reasons for withdrawal
| Measure |
Number of Oxycodone Tablets Typically Prescribed
Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
Half the Number of Oxycodone Tablets Typically Prescribed
Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Allergy
|
2
|
0
|
|
Overall Study
Protocol Violation
|
0
|
3
|
|
Overall Study
Did not complete Day 1 Survey
|
5
|
10
|
|
Overall Study
Did not complete Day 7 Survey
|
5
|
2
|
Baseline Characteristics
Ambulatory Gynecologic Surgery: Finding the Optimal Opioid Prescription
Baseline characteristics by cohort
| Measure |
Number of Oxycodone Tablets Typically Prescribed
n=57 Participants
Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
Half the Number of Oxycodone Tablets Typically Prescribed
n=57 Participants
Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.4 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
36.2 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
32 participants
n=5 Participants
|
39 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
12 participants
n=5 Participants
|
9 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-operativePopulation: Participants answering Day 1 Survey
During the survey phone call on day 1, participants will be asked to report the total number of oxycodone tablets use since the surgery.
Outcome measures
| Measure |
Number of Oxycodone Tablets Typically Prescribed
n=52 Participants
Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
Half the Number of Oxycodone Tablets Typically Prescribed
n=47 Participants
Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
|---|---|---|
|
Number of Oxycodone Tablets Used Day 1
|
1.0 Oxycodone Tablets
Interval 0.0 to 1.0
|
1.0 Oxycodone Tablets
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: 7 days post-operativePopulation: Participants who answered survey on Day 7. Not all participants answered each question on follow up surveys.
During the survey phone call on day 7, participants will be asked to report the total number of oxycodone tablets used since the surgery.
Outcome measures
| Measure |
Number of Oxycodone Tablets Typically Prescribed
n=46 Participants
Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
Half the Number of Oxycodone Tablets Typically Prescribed
n=44 Participants
Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
|---|---|---|
|
Number of Oxycodone Tablets Used as Reported by Participants 1 Week After Surgery
|
2.5 Oxycodone Tablets
Interval 0.0 to 5.0
|
2.0 Oxycodone Tablets
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: 1 day post operativePopulation: Participants completing Day 1 Survey
Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain)
Outcome measures
| Measure |
Number of Oxycodone Tablets Typically Prescribed
n=52 Participants
Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
Half the Number of Oxycodone Tablets Typically Prescribed
n=47 Participants
Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
|---|---|---|
|
Self Reported Pain Score on Post Operative Day 1 (Numeric Pain Reporting Score: NRS)
|
5.0 Score on Numeric Pain Scale
Interval 3.0 to 7.0
|
5 Score on Numeric Pain Scale
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: 7 days post operativePopulation: Participants completing Day 7 Survey
Participants will be surveyed during the phone call survey to rate pain score on a scale from 0 (no pain), to 10 (severe pain)
Outcome measures
| Measure |
Number of Oxycodone Tablets Typically Prescribed
n=47 Participants
Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
Half the Number of Oxycodone Tablets Typically Prescribed
n=45 Participants
Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
|---|---|---|
|
Self Reported Pain Score on Post Operative Day 7 (Numeric Pain Reporting Score: NRS)
|
2.0 Score on Numeric Pain Scale
Interval 0.0 to 4.0
|
1.3 Score on Numeric Pain Scale
Interval 0.0 to 3.3
|
SECONDARY outcome
Timeframe: 1 week post operativeBy chart review, unscheduled interactions with the healthcare system related to pain will be counted.These will include phone calls related to pain, unscheduled visits to the office or emergency department
Outcome measures
| Measure |
Number of Oxycodone Tablets Typically Prescribed
n=57 Participants
Participants will receive a prescription for 10 tablets of 5 mg oxycodone (1 tablet every 6 hours as needed) as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
Half the Number of Oxycodone Tablets Typically Prescribed
n=57 Participants
Participants will receive 5 tablets of 5mg oxycodone as well as 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed) and 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed).
Acetaminophen: 50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
Ibuprofen 600 mg: 25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
Oxycodone: The number of tablets of oxycodone prescribed is the only difference between the two arms.
|
|---|---|---|
|
Additional Contacts With Provider
|
1 Unscheduled patient contacts
|
4 Unscheduled patient contacts
|
Adverse Events
Number of Oxycodone Tablets Typically Prescribed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Half the Number of Oxycodone Tablets Typically Prescribed
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place