Prevention of Persistent Opioid Use in Mothers
Primary Purpose
Opioid Use, Postpartum Disorder, Chronic Pain Syndrome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Gabapentin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use
Eligibility Criteria
Inclusion Criteria:
- Delivery within 5 days, able to provide informed consent, English speaker
Exclusion Criteria:
- Opiate use disorder
Sites / Locations
- Lucille Packard Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gabapentin
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Time to Opioid Cessation as a Measure of Opioid Utilization
Secondary Outcome Measures
Pain Report
Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain).
Functional Recovery
Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03472521
Brief Title
Prevention of Persistent Opioid Use in Mothers
Official Title
Prevention of Persistent Pain and Opioid Use in Mothers - POMS
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
April 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Postpartum Disorder, Chronic Pain Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A randomization table will be used by the research pharmacy and study drug will be prepared in numbered bottles.
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Active
Intervention Description
Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match gabapentin
Primary Outcome Measure Information:
Title
Time to Opioid Cessation as a Measure of Opioid Utilization
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Pain Report
Description
Number of weeks after delivery until resolution of pain as reported by participants. Pain score was averaged each week from daily reporting by participants using a numerical rating scale (range: 1-10, 1 = no pain; 10 = worst pain).
Time Frame
12 weeks
Title
Functional Recovery
Description
Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Fatigue
Description
PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time Frame
12 weeks
Title
Depression
Description
PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time Frame
12 weeks
Title
Anxiety
Description
PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time Frame
12 weeks
Title
PROMIS Physical Function
Description
PROMIS Physical Function questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time Frame
12 weeks after delivery
Title
Steps
Description
Fitness tracker measured steps
Time Frame
12 weeks after delivery
Title
Sleep
Description
Fitness tracker measured sleep
Time Frame
12 weeks after delivery
Title
Heart Rate
Description
Fitness tracker measured heart rate
Time Frame
12 weeks after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Delivery within 5 days, able to provide informed consent, English speaker
Exclusion Criteria:
Opiate use disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Flood, MD, MA
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lucille Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28926443
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.
Results Reference
background
PubMed Identifier
30032880
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.
Results Reference
background
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Prevention of Persistent Opioid Use in Mothers
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