Phase 4
N=78
Prevention of Persistent Opioid Use in Mothers
Opioid Use · Postpartum Disorder · Chronic Pain Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03472521 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Time to Opioid Cessation as a Measure of Opioid Utilization — 2; 2 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Gabapentin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Opioid Cessation as a Measure of Opioid Utilization |
2; 2 | — |
| SECONDARY Pain Report |
7; 12 | — |
| SECONDARY Functional Recovery |
8; 11 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Delivery within 5 days, able to provide informed consent, English speaker
Exclusion Criteria
- Opiate use disorder
Data sourced from ClinicalTrials.gov (NCT03472521). 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.