Trial Outcomes & Findings for A Randomized-controlled Trial of Post-operative Opiate Quantities After Urogynecologic Surgery (NCT NCT03319277)
NCT ID: NCT03319277
Last Updated: 2019-10-31
Results Overview
Patient satisfaction was easured by the way they answered the following question: "Overall, how satisfied are you with your pain medication at home since your surgery?" Their answers were recorded via a rated scale with five options: "Very Satisfied", "Somewhat Satisfied", "Neutral", "Somewhat Satisfied", and "Very Unsatisfied" which goes from most favorable to least favorable, respectively. Patients who answered either "Very Satisfied" or "Somewhat Satisfied" were defined a priori to have adequate satisfaction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
6-weeks after surgery
Results posted on
2019-10-31
Participant Flow
Participant milestones
| Measure |
Routine Opiate Prescription
This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the standard amount of post-discharge opiate medications - 28 tablets of oxycodone 5mg.
Routine opiate prescription: The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge.
|
Decreased Opiate Prescription
This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the decreased amount of post-discharge opiate medications - 5 tablets of oxycodone 5mg with a paper prescription for an additional 10 tablets of oxycodone 5mg as a backup for uncontrolled pain.
Decreased opiate prescription: The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
|
Overall Study
COMPLETED
|
59
|
59
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized-controlled Trial of Post-operative Opiate Quantities After Urogynecologic Surgery
Baseline characteristics by cohort
| Measure |
Routine Opiate Prescription
n=59 Participants
This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the standard amount of post-discharge opiate medications - 28 tablets of oxycodone 5mg.
Routine opiate prescription: The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge.
|
Decreased Opiate Prescription
n=59 Participants
This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the decreased amount of post-discharge opiate medications - 5 tablets of oxycodone 5mg with a paper prescription for an additional 10 tablets of oxycodone 5mg as a backup for uncontrolled pain.
Decreased opiate prescription: The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
63 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
62 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
118 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
White
|
50 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
59 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6-weeks after surgeryPopulation: Two patients in the decreased opiate prescription group did not complete the follow-up survey.
Patient satisfaction was easured by the way they answered the following question: "Overall, how satisfied are you with your pain medication at home since your surgery?" Their answers were recorded via a rated scale with five options: "Very Satisfied", "Somewhat Satisfied", "Neutral", "Somewhat Satisfied", and "Very Unsatisfied" which goes from most favorable to least favorable, respectively. Patients who answered either "Very Satisfied" or "Somewhat Satisfied" were defined a priori to have adequate satisfaction.
Outcome measures
| Measure |
Routine Opiate Prescription
n=59 Participants
This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the standard amount of post-discharge opiate medications - 28 tablets of oxycodone 5mg.
Routine opiate prescription: The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge.
|
Decreased Opiate Prescription
n=57 Participants
This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the decreased amount of post-discharge opiate medications - 5 tablets of oxycodone 5mg with a paper prescription for an additional 10 tablets of oxycodone 5mg as a backup for uncontrolled pain.
Decreased opiate prescription: The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets.
|
|---|---|---|
|
Number of Patients Reporting Adequate Satisfaction
|
55 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: 6-weeks after surgeryTotal number of prescribed tablets used by patients
Outcome measures
| Measure |
Routine Opiate Prescription
n=59 Participants
This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the standard amount of post-discharge opiate medications - 28 tablets of oxycodone 5mg.
Routine opiate prescription: The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge.
|
Decreased Opiate Prescription
n=59 Participants
This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the decreased amount of post-discharge opiate medications - 5 tablets of oxycodone 5mg with a paper prescription for an additional 10 tablets of oxycodone 5mg as a backup for uncontrolled pain.
Decreased opiate prescription: The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets.
|
|---|---|---|
|
Number of Opiate Tablets Used by Patients
|
3 number of tablets
Interval 0.0 to 14.0
|
1 number of tablets
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 6-weeks after surgeryPatient answered "yes" to the following question: "Would you be willing to destroy any remaining opiate pain medication?"
Outcome measures
| Measure |
Routine Opiate Prescription
n=53 Participants
This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the standard amount of post-discharge opiate medications - 28 tablets of oxycodone 5mg.
Routine opiate prescription: The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge.
|
Decreased Opiate Prescription
n=53 Participants
This arm will receive the standard post-discharge prescriptions of ibuprofen, docusate, acetaminophen, and polyethylene glycol. In addition, they will receive the decreased amount of post-discharge opiate medications - 5 tablets of oxycodone 5mg with a paper prescription for an additional 10 tablets of oxycodone 5mg as a backup for uncontrolled pain.
Decreased opiate prescription: The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets.
|
|---|---|---|
|
Number of Patients Willing to Destroy Excess Remaining Opioid Tablets
|
51 Participants
|
50 Participants
|
Adverse Events
Routine Opiate Prescription
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Decreased Opiate Prescription
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