Prevention of Persistent Opioid Use in Mothers
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|ClinicalTrials.gov Identifier: NCT03472521|
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : November 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use Postpartum Disorder Chronic Pain Syndrome||Drug: Gabapentin Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double blind randomized|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||A randomization table will be used by the research pharmacy and study drug will be prepared in numbered bottles.|
|Official Title:||Prevention of Persistent Pain and Opioid Use in Mothers - POMS|
|Actual Study Start Date :||September 17, 2018|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||March 31, 2021|
Gabapentin 300 mg capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.
Other Name: Active
Placebo Comparator: Control
Matched placebo capsules will be prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Placebo to match gabapentin
- Opioid Utilization [ Time Frame: 12 weeks ]Opioid utilization will be primarily in days and secondarily in mg.
- Pain Report [ Time Frame: 12 weeks ]Average pain will be reported on a numerical rating scale daily and compared as area under the curve of pain/days or time to cessation
- Functional recovery [ Time Frame: 12 weeks ]Functional will be assessed with the PROMIS Physical Function questionaire. Functional recovery will be assessed as the number of days to return to pre-delivery function.
- Fatigue [ Time Frame: 12 weeks ]PROMIS Fatigue 4 questionaire will be used to assess fatigue as a modifier of the above outcomes.
- Depression [ Time Frame: 12 weeks ]PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
- Anxiety [ Time Frame: 12 weeks ]PROMIS Anxiety 4 questionaire will be used to assess fatigue as a modifier of the above outcomes.
- Steps [ Time Frame: 12 weeks after delivery ]Fitness tracker measured steps
- sleep [ Time Frame: 12 weeks after delivery ]Fitness tracker measured sleep
- heart rate [ Time Frame: 12 weeks after delivery ]Fitness tracker measured heart rate
- PROMIS physical function [ Time Frame: 12 weeks after delivery ]PROMIS Physical Function questionaire will be used to assess fatigue as a modifier of the above outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472521
|Contact: Pamela Flood, MD, MAemail@example.com|
|Contact: Brendan Carvalho, MBBCh, MDCHfirstname.lastname@example.org|
|Principal Investigator:||Pamela Flood, MD, MA||Stanford University|