Opioid Use, Surgery
Conditions
Keywords
safe opioid prescribing
Brief summary
The number of opioid overdose deaths in the United States has quadrupled in 15 years, a dramatic manifestation of the current opioid abuse epidemic. This rise parallels a sharp increase in the amount of legal prescription opioids dispensed. The abundance of prescription opioids available is a primary pathway for opioid abuse and diversion. Adjusting post- cesarean delivery opioid prescribing practices to better match actual patient need has the potential to reduce unused opioids available for diversion, nonmedical use, and development of chronic dependence, as well as reduce wasted resources.
Detailed description
Preliminary data from a quality improvement project performed in our department found that most women are prescribed opioids after discharge that were significantly in excess of the actual opioids used. However there is a subset of women (\ 25%) who use all opioids and complain that they were not prescribed enough. The only variable predictive of post- discharge opioid use was Inpatient opioid use. These data were used to develop a formula for estimating outpatient use based on inpatient use. Currently there are no guidelines for outpatient prescribing either at our institution or on a national level. On average, most patients at our institution received 30 tablets of 5mg oxycodone at discharge. In surveying providers, very few looked at inpatient use and most had a standard prescription that they gave everyone.
Interventions
OTHERTailored prescription
Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use
OTHERControl
Participants will be prescribed 30 tablets of oxycodone 5mg
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants were randomized to either a personalized prescribing algorithm based off of inpatient opioid use versus standard discharge opioid prescribing.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Women 18-50 years old * Women undergoing cesarean delivery at a single institution
Exclusion criteria
* Major post-surgical complications: cesarean hysterectomy, bowl or bladder injury, reoperation, ICU admission, wound infection or separation * Chronic opioid use: Taking buprenorphine during pregnancy, taking an opioid for \> 7 days during pregnancy. * Non English or Spanish speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unused Opioids | 4 weeks postpartum | oxycodone 5mg tablet leftover from prescription at discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain: Frequency That Participants Reported Uncontrolled Pain | 4 weeks postpartum | Frequency that participants reported uncontrolled pain Pain scores were examined based on how many negative responses indicating worse pain were reported to the five questions relating to analgesic adequacy. Thus participants could have a score that ranged from 0 to 5. Question 1 - I was discharged with too few opioid pills (Yes=1, No=0) Question 2 - Overall, my pain is poorly controlled by these medications (Yes=1, No=0) Question 3 - Overall, my pain from delivery has been worse than expected (Yes=1, No=0) Question 4 - Pain interfered significantly with my ability to do normal activities (Yes=1, No=0) Question 5 - Since discharge, I needed more opioid than what was expected (Yes=1, No=0) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tailored Participants will be prescribed an opioid based on a formula derived from inpatient opioid use
Tailored prescription: Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use | 94 |
| Control Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.
Control: Participants will be prescribed 30 tablets of oxycodone 5mg | 96 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 8 |
| Overall Study | unable to confirm post op opioids | 2 | 3 |
Baseline characteristics
| Characteristic | Tailored | Total | Control |
|---|---|---|---|
| Age, Continuous | 29.4 years STANDARD_DEVIATION 5.9 | 30.4 years STANDARD_DEVIATION 2.8 | 30.4 years STANDARD_DEVIATION 5.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 7 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 27 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 25 Participants | 15 Participants |
| Race (NIH/OMB) White | 53 Participants | 113 Participants | 60 Participants |
| Region of Enrollment United States | 87 participants | 172 participants | 85 participants |
| Sex: Female, Male Female | 87 Participants | 172 Participants | 85 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 96 |
| other Total, other adverse events | 0 / 94 | 0 / 96 |
| serious Total, serious adverse events | 1 / 94 | 0 / 96 |
Outcome results
Primary
Unused Opioids
oxycodone 5mg tablet leftover from prescription at discharge
Time frame: 4 weeks postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tailored | Unused Opioids | 5 oxycodone 5mg tablets |
| Control | Unused Opioids | 10 oxycodone 5mg tablets |
Secondary
Pain: Frequency That Participants Reported Uncontrolled Pain
Frequency that participants reported uncontrolled pain Pain scores were examined based on how many negative responses indicating worse pain were reported to the five questions relating to analgesic adequacy. Thus participants could have a score that ranged from 0 to 5. Question 1 - I was discharged with too few opioid pills (Yes=1, No=0) Question 2 - Overall, my pain is poorly controlled by these medications (Yes=1, No=0) Question 3 - Overall, my pain from delivery has been worse than expected (Yes=1, No=0) Question 4 - Pain interfered significantly with my ability to do normal activities (Yes=1, No=0) Question 5 - Since discharge, I needed more opioid than what was expected (Yes=1, No=0)
Time frame: 4 weeks postpartum
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tailored | Pain: Frequency That Participants Reported Uncontrolled Pain | 4 score on a scale |
| Control | Pain: Frequency That Participants Reported Uncontrolled Pain | 3 score on a scale |