N/A
N=51
Shared Decision Making for Prescription Opioids After Cesarean Delivery
Pregnancy · Cesarean Section · Prescriptions · Analgesics, Opioid
Bottom Line
View on ClinicalTrials.gov: NCT02770612 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Pain Management and Opioid Usage Measured by Telephone Questionnaire — 20.0; 20.0; 15.5; 4.0 number of oxycodone 5mg tablets — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prescribed opioids (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Management and Opioid Usage Measured by Telephone Questionnaire |
20.0; 20.0; 15.5; 4.0 | <0.001 sig |
Summary
The specific aim of this study is to use a shared decision making tool to allow women who have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will be prescribed at discharge, within a range from 0-40 tablets. The study investigators will document additional information from medical record abstraction (age, race/ethnicity, medical and obstetrical conditions, previous opioid use, date of CD, indication for CD, anesthetic management during CD, duration and complications of CD, length of stay, pain medication use and pain scores on each postoperative day between CD and discharge). The investigators will then follow up with the participants by telephone at two weeks after discharge to assess the amount of opioid used, frequency of prescription refill, disposition of unused medication, and participant satisfaction with their post-cesarean pain control. The investigators hypothesize that the use of a shared decision making tool will decrease the amount of opioid prescribed while still providing participants with satisfactory pain control.
Eligibility Criteria
Inclusion Criteria
- Postpartum women who underwent a cesarean delivery at MGH
Exclusion Criteria
- Non-native English speakers (identified in LMR as "non-English speaking" or "requires interpreter")
- Women with a history of chronic opioid abuse (identified in LMR as "opioid abuse" or "narcotic abuse")
- Chronic pain on opioids (identified in LMR as "chronic pain" or "chronic narcotic use")
- Women on methadone or buprenorphine for treatment of opioid addiction (identified from their medication list in the LMR)
- Women with impaired decision-making abilities
- Women hospitalized for > 7 days related to CD
- Minors (<18 years old)
- Women being prescribed an opioid other than oxycodone during their postpartum hospitalization (identified from the MAR and discussion with rounding providers)
- Women with contraindications to taking acetaminophen or NSAIDs
Data sourced from ClinicalTrials.gov (NCT02770612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.