NCT03472521

Prevention of Persistent Opioid Use in Mothers

Prevention of Persistent Pain and Opioid Use in Mothers - POMS

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use
• Postpartum Disorder
• Chronic Pain Syndrome

Interventions

Type	Name	Description
DRUG	Gabapentin	Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.
DRUG	Placebo	Placebo to match gabapentin

Timeline

• Start date: 2018-09-17
• Primary completion: 2020-07-02
• Completion: 2021-04-10
• First posted: 2018-03-21
• Last updated: 2022-05-05
• Results posted: 2021-11-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study