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Prevention of Persistent Opioid Use in Mothers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03472521
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Pamela Flood, Stanford University

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.

Condition or disease Intervention/treatment Phase
Opioid Use Postpartum Disorder Chronic Pain Syndrome Drug: Gabapentin Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gabapentin
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.
Drug: Gabapentin
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.
Drug: Placebo
Placebo to match gabapentin




Primary Outcome Measures :
  1. Opioid Utilization [ Time Frame: 12 weeks ]
    Opioid utilization will be primarily in days and secondarily in mg.


Secondary Outcome Measures :
  1. 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

  2. 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.


Other Outcome Measures:
  1. Fatigue [ Time Frame: 12 weeks ]
    PROMIS Fatigue 4 questionaire will be used to assess fatigue as a modifier of the above outcomes.

  2. Depression [ Time Frame: 12 weeks ]
    PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

  3. Anxiety [ Time Frame: 12 weeks ]
    PROMIS Anxiety 4 questionaire will be used to assess fatigue as a modifier of the above outcomes.

  4. Steps [ Time Frame: 12 weeks after delivery ]
    Fitness tracker measured steps

  5. sleep [ Time Frame: 12 weeks after delivery ]
    Fitness tracker measured sleep

  6. heart rate [ Time Frame: 12 weeks after delivery ]
    Fitness tracker measured heart rate

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Opiate use disorder

Information from the National Library of Medicine

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


Contacts
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Contact: Pamela Flood, MD, MA 201-370-3933 pflood@stanford.edu
Contact: Brendan Carvalho, MBBCh, MDCH 650-861-8607 carvalb@stanford.edu

Locations
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United States, California
Lucille Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94305
Contact: Araseli Hernandez    650-723-5439    araselih@stanford.edu   
Contact: Pamela Flood, MD,MA    201-370-3933    pflood@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Pamela Flood, MD, MA Stanford University
Publications:
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Responsible Party: Pamela Flood, Professor, Anesthesiology, Perioperative and Pain Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03472521    
Other Study ID Numbers: IRB-43964
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Puerperal Disorders
Chronic Pain
Pain
Neurologic Manifestations
Pregnancy Complications
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents