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=5 Participants	55.3 years STANDARD_DEVIATION 2.0 • n=7 Participants	58.6 years STANDARD_DEVIATION 2.9 • n=5 Participants	54 years STANDARD_DEVIATION 3.4 • n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	10 Participants n=7 Participants	2 Participants n=5 Participants	31 Participants n=4 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	32 Participants n=7 Participants	27 Participants n=5 Participants	98 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	31 Participants n=7 Participants	22 Participants n=5 Participants	100 Participants n=4 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	58 participants n=5 Participants	42 participants n=7 Participants	29 participants n=5 Participants	129 participants n=4 Participants
BMI	27.8 kg/m^2 n=5 Participants	27.9 kg/m^2 n=7 Participants	25.4 kg/m^2 n=5 Participants	27 kg/m^2 n=4 Participants

PRIMARY outcome

Timeframe: 14 days

Patients 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	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.
Morphine Milligram Equivalents Taken by Participants	46 morphine milligram equivalents Interval 37.5 to 75.0	15 morphine milligram equivalents Interval 11.0 to 22.5	0 morphine milligram equivalents Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 14 days

Patient 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	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.
Satisfaction Scores Ranging From 1 - 10	10 units on a scale Interval 9.0 to 10.0	10 units on a scale Interval 9.0 to 10.0	10 units on a scale Interval 8.5 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

Research Resident

Thomas Jefferson University Hospital

Phone: 516-547-7676

Email: ryan.lamm@jefferson.edu

Results disclosure agreements

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