Chronic Pain Syndrome, Opioid Use, Postpartum Disorder
Conditions
Brief summary
Our previous work has identified the group of women at risk for prolonged pain, opioid use and poor functional recovery after childbirth. The optimal intervention to mitigate this risk is unknown. We propose to test an analgesic adjutant that is commonly used for post-operative pain compared to placebo to improve post-partum recovery.
Detailed description
A small percent of the large population of women who give birth have difficulty with prolonged pain, opioid use and poor functional recovery. This may be the first opiate exposure and significant health challenge in a young woman's life. In our previous work, we have identified 20% who are at highest risk for prolonged pain and delayed opioid cessation and functional recovery with usual care. Moderate to severe pain on postpartum day 1 is a significant predictor of being in the risk group. The optimal intervention to mitigate this risk is unknown. We plan to test an intervention of low dose gabapentin or placebo to be escalated by a pain medicine doctor as needed. We hypothesize that additional care of women predicted to be higher need by virtue of their postoperative day one pain score (\> 6 x2) despite usual multimodal analgesic care will lead to reduced need for opioid, less pain and more rapid functional recovery.
Interventions
DRUGGabapentin
Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.
DRUGPlacebo
Placebo to match gabapentin
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
A randomization table will be used by the research pharmacy and study drug will be prepared in numbered bottles.
Intervention model description
Double blind randomized
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Delivery within 5 days, able to provide informed consent, English speaker
Exclusion criteria
* Opiate use disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Opioid Cessation as a Measure of Opioid Utilization | Up to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Report | 12 weeks | Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain). |
| Functional Recovery | 12 weeks | Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function. |
Other
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Physical Function | 12 weeks after delivery | PROMIS Physical Function questionnaire will be used to assess fatigue as a modifier of the above outcomes. |
| Steps | 12 weeks after delivery | Fitness tracker measured steps |
| Fatigue | 12 weeks | PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes. |
| Heart Rate | 12 weeks after delivery | Fitness tracker measured heart rate |
| Sleep | 12 weeks after delivery | Fitness tracker measured sleep |
| Depression | 12 weeks | PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes. |
| Anxiety | 12 weeks | PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin Gabapentin 300 mg capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist. | 41 |
| Control Matched placebo capsules, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist. | 37 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued intervention | 3 | 1 |
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Gabapentin | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 37 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 11 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 26 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 12 Participants | 13 Participants | 25 Participants |
| Race/Ethnicity, Customized Caucasian | 15 Participants | 13 Participants | 28 Participants |
| Race/Ethnicity, Customized Other | 10 Participants | 7 Participants | 17 Participants |
| Race/Ethnicity, Customized Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 41 Participants | 37 Participants | 78 Participants |
| Sex: Female, Male Female | 41 Participants | 37 Participants | 78 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 / 41 | 0 / 37 |
| other Total, other adverse events | 0 / 41 | 0 / 37 |
| serious Total, serious adverse events | 0 / 41 | 0 / 37 |
Outcome results
Primary
Time to Opioid Cessation as a Measure of Opioid Utilization
Time frame: Up to 12 weeks
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin | Time to Opioid Cessation as a Measure of Opioid Utilization | 2 weeks |
| Control | Time to Opioid Cessation as a Measure of Opioid Utilization | 2 weeks |
Secondary
Functional Recovery
Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function.
Time frame: 12 weeks
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin | Functional Recovery | 8 weeks |
| Control | Functional Recovery | 11 weeks |
Secondary
Pain Report
Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain).
Time frame: 12 weeks
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin | Pain Report | 7 weeks |
| Control | Pain Report | 12 weeks |
Other Pre-specified
Anxiety
PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time frame: 12 weeks
Other Pre-specified
Depression
PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time frame: 12 weeks
Other Pre-specified
Fatigue
PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time frame: 12 weeks
Other Pre-specified
Heart Rate
Fitness tracker measured heart rate
Time frame: 12 weeks after delivery
Other Pre-specified
PROMIS Physical Function
PROMIS Physical Function questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time frame: 12 weeks after delivery
Other Pre-specified
Sleep
Fitness tracker measured sleep
Time frame: 12 weeks after delivery
Other Pre-specified
Steps
Fitness tracker measured steps
Time frame: 12 weeks after delivery