Analgesics, Opioid, Cesarean Section, Pregnancy, Prescriptions
Conditions
Brief 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.
Interventions
OTHERPrescribed opioids
Making a shared decision with post-cesarean delivery mothers about quantity of opioids prescribed at discharge
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Management and Opioid Usage Measured by Telephone Questionnaire | Within 2 weeks postpartum | Outpatient opioid selection and use after discharge |
Countries
United States
Participant flow
Pre-assignment details
1 individual met exclusion criteria after agreeing to participate, due to postoperative length of stay \> 7 days, and was not consented
Participants by arm
| Arm | Count |
|---|---|
| Massachusetts General Hospital 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 | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Met exclusion criteria (postop LOS>7d) | 1 |
Baseline characteristics
| Characteristic | Massachusetts General Hospital |
|---|---|
| Age, Continuous | 33.0 years |
| Postoperative length of stay | 4.0 days |
| Race/Ethnicity, Customized Asian | 14 Participants |
| Race/Ethnicity, Customized Black | 0 Participants |
| Race/Ethnicity, Customized Hispanic | 8 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 27 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 0 Participants |
| Timing of cesarean delivery Planned | 19 Participants |
| Timing of cesarean delivery Unplanned | 31 Participants |
| Type of cesarean delivery Primary | 35 Participants |
| Type of cesarean delivery Repeat | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Pain Management and Opioid Usage Measured by Telephone Questionnaire
Outpatient opioid selection and use after discharge
Time frame: Within 2 weeks postpartum
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Massachusetts General Hospital | Pain Management and Opioid Usage Measured by Telephone Questionnaire | Number of oxycodone tablets used | 15.5 number of oxycodone 5mg tablets |
| Massachusetts General Hospital | Pain Management and Opioid Usage Measured by Telephone Questionnaire | Number of oxycodone tablets remaining | 4.0 number of oxycodone 5mg tablets |
| Massachusetts General Hospital | Pain Management and Opioid Usage Measured by Telephone Questionnaire | Number of oxycodone tablets selected | 20.0 number of oxycodone 5mg tablets |
| Massachusetts General Hospital | Pain Management and Opioid Usage Measured by Telephone Questionnaire | Number of oxycodone tablets dispensed | 20.0 number of oxycodone 5mg tablets |
Comparison: We used a one sided one sample Wilcoxon test to compare the median number of oxycodone tablets chosen and prescribed to the institutional standard of 40 tablets of oxycodone 5mg on dischargep-value: <0.001Wilcoxon (Mann-Whitney)