Trial Outcomes & Findings for Shared Decision Making for Prescription Opioids After Cesarean Delivery (NCT NCT02770612)

Last Updated: 2019-03-07

Results Overview

Outpatient opioid selection and use after discharge

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Within 2 weeks postpartum

Results posted on

2019-03-07

1 individual met exclusion criteria after agreeing to participate, due to postoperative length of stay \> 7 days, and was not consented

Participant milestones
Measure	Post-cesarean Delivery Mothers Intervention: 10-minute shared decision making session via tablet
Overall Study STARTED	51
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	1

Reasons for withdrawal
Measure	Post-cesarean Delivery Mothers Intervention: 10-minute shared decision making session via tablet
Overall Study Met exclusion criteria (postop LOS>7d)	1

Shared Decision Making for Prescription Opioids After Cesarean Delivery

Baseline characteristics by cohort
Measure	Massachusetts General Hospital n=50 Participants Women who were postoperative day 3 from cesarean delivery, and were eligible Eligibility criteria 1. English speaking 2. using oral oxycodone 3. age \>=18 4. post-operative length of stay less than 8 days 5. no history of chronic pain or chronic opioid use 6. lack of contraindications to tylenol/NSAIDs
Age, Continuous	33.0 years n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White	27 Participants n=5 Participants
Race/Ethnicity, Customized Black	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	14 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Type of cesarean delivery Primary	35 Participants n=5 Participants
Type of cesarean delivery Repeat	15 Participants n=5 Participants
Timing of cesarean delivery Planned	19 Participants n=5 Participants
Timing of cesarean delivery Unplanned	31 Participants n=5 Participants
Postoperative length of stay	4.0 days n=5 Participants

Timeframe: Within 2 weeks postpartum

Outpatient opioid selection and use after discharge

Outcome measures
Measure	Massachusetts General Hospital n=50 Participants Women who were postoperative day 3 from cesarean delivery, and were eligible Eligibility criteria 1. English speaking 2. using oral oxycodone 3. age \>=18 4. post-operative length of stay less than 8 days 5. no history of chronic pain or chronic opioid use 6. lack of contraindications to tylenol/NSAIDs
Pain Management and Opioid Usage Measured by Telephone Questionnaire Number of oxycodone tablets selected	20.0 number of oxycodone 5mg tablets Interval 15.0 to 25.0
Pain Management and Opioid Usage Measured by Telephone Questionnaire Number of oxycodone tablets dispensed	20.0 number of oxycodone 5mg tablets Interval 20.0 to 30.0
Pain Management and Opioid Usage Measured by Telephone Questionnaire Number of oxycodone tablets used	15.5 number of oxycodone 5mg tablets Interval 8.0 to 25.0
Pain Management and Opioid Usage Measured by Telephone Questionnaire Number of oxycodone tablets remaining	4.0 number of oxycodone 5mg tablets Interval 0.0 to 8.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Brigham and Women's Hospital

Phone: 617-278-0930