Clinical trial NCT03472521: Prevention of Persistent Opioid Use in Mothers
Official title: Prevention of Persistent Pain and Opioid Use in Mothers - POMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Opioid Use
Postpartum Disorder
Chronic Pain Syndrome
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Delivery within 5 days, able to provide informed consent, English speaker

Exclusion Criteria:

* Opiate use disorder

Primary outcomes:
measure: Time to Opioid Cessation as a Measure of Opioid Utilization
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Pain Report
timeFrame: 12 weeks
measure: Functional Recovery
timeFrame: 12 weeks
Other outcomes:
measure: Fatigue
timeFrame: 12 weeks
measure: Depression
timeFrame: 12 weeks
measure: Anxiety
timeFrame: 12 weeks
measure: PROMIS Physical Function
timeFrame: 12 weeks after delivery
measure: Steps
timeFrame: 12 weeks after delivery
measure: Sleep
timeFrame: 12 weeks after delivery
measure: Heart Rate
timeFrame: 12 weeks after delivery
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Pamela Flood, MD, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Komatsu R, Carvalho B, Flood PD. Recovery after Nulliparous Birth: A Detailed Analysis of Pain Analgesia and Recovery of Function. Anesthesiology. 2017 Oct;127(4):684-694. doi: 10.1097/ALN.0000000000001789.
citation: Komatsu R, Carvalho B, Flood P. Prediction of outliers in pain, analgesia requirement, and recovery of function after childbirth: a prospective observational cohort study. Br J Anaesth. 2018 Aug;121(2):417-426. doi: 10.1016/j.bja.2018.04.033.