Trial Outcomes & Findings for Toward Zero Prescribed Opioids for Outpatient General Surgery (NCT NCT05327777)
NCT ID: NCT05327777
Last Updated: 2023-06-05
Results Overview
Patients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
129 participants
Primary outcome timeframe
14 days
Results posted on
2023-06-05
Participant Flow
Participant milestones
| Measure |
Control
Normal standard practices
|
Opioid Sparing
Providers required to prescribe 10 narcotic pills only
Oxycodone: Investigators provided set opioid prescriptions for 10 pills each patient.
|
Zero Opioid
No narcotic prescription is provided to patient at discharge
Zero Opioid Protocol: Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
42
|
29
|
|
Overall Study
COMPLETED
|
58
|
42
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Toward Zero Prescribed Opioids for Outpatient General Surgery
Baseline characteristics by cohort
| Measure |
Control
n=58 Participants
Normal standard practices
|
Opioid Sparing
n=42 Participants
Providers required to prescribe 10 narcotic pills only
Oxycodone: Investigators provided set opioid prescriptions for 10 pills each patient.
|
Zero Opioid
n=29 Participants
No narcotic prescription is provided to patient at discharge
Zero Opioid Protocol: Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
|
Total
n=129 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 1.8 • n=99 Participants
|
55.3 years
STANDARD_DEVIATION 2.0 • n=107 Participants
|
58.6 years
STANDARD_DEVIATION 2.9 • n=206 Participants
|
54 years
STANDARD_DEVIATION 3.4 • n=157 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
31 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
98 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
15 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
100 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=99 Participants
|
42 participants
n=107 Participants
|
29 participants
n=206 Participants
|
129 participants
n=157 Participants
|
|
BMI
|
27.8 kg/m^2
n=99 Participants
|
27.9 kg/m^2
n=107 Participants
|
25.4 kg/m^2
n=206 Participants
|
27 kg/m^2
n=157 Participants
|
PRIMARY outcome
Timeframe: 14 daysPatients will be interviewed fourteen days after procedure and asked how many opioid pills they have taken since being discharged form the hospitals
Outcome measures
| Measure |
Zero Opioid
n=29 Participants
No narcotic prescription is provided to patient at discharge
Zero Opioid Protocol: Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
|
Control
n=58 Participants
Normal standard practices
|
Opioid Sparing
n=42 Participants
Providers required to prescribe 10 narcotic pills only
Oxycodone: Investigators provided set opioid prescriptions for 10 pills each patient.
|
|---|---|---|---|
|
Morphine Milligram Equivalents Taken by Participants
|
0 morphine milligram equivalents
Interval 0.0 to 0.0
|
46 morphine milligram equivalents
Interval 37.5 to 75.0
|
15 morphine milligram equivalents
Interval 11.0 to 22.5
|
SECONDARY outcome
Timeframe: 14 daysPatient will be asked to rank their satisfaction scores on a scale from 1 - 10 (with 1 being extremely dissatisfied and 10 being extremely satisfied) since discharge from the hospital
Outcome measures
| Measure |
Zero Opioid
n=29 Participants
No narcotic prescription is provided to patient at discharge
Zero Opioid Protocol: Investigators provided no opioid prescriptions at discharge and instead provided information on non-narcotic pain control.
|
Control
n=58 Participants
Normal standard practices
|
Opioid Sparing
n=42 Participants
Providers required to prescribe 10 narcotic pills only
Oxycodone: Investigators provided set opioid prescriptions for 10 pills each patient.
|
|---|---|---|---|
|
Satisfaction Scores Ranging From 1 - 10
|
10 units on a scale
Interval 8.5 to 10.0
|
10 units on a scale
Interval 9.0 to 10.0
|
10 units on a scale
Interval 9.0 to 10.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Opioid Sparing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Zero Opioid
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