Prevention of Persistent Opioid Use in Mothers

• ClinicalTrials.gov Identifier: NCT03472521
• Recruitment Status: Completed
• First Posted: March 21, 2018
• Results First Posted: November 4, 2021
• Last Update Posted: November 4, 2021
• Sponsor: Stanford University
• Information provided by (Responsible Party): Pamela Flood, Stanford University

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.

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 78 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
• Actual Primary Completion Date: July 2, 2020
• Actual Study Completion Date: April 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Time to Opioid Cessation as a Measure of Opioid Utilization [ Time Frame: Up to 12 weeks ]

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 questionnaire. 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 questionnaire 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 questionnaire 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 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

Lucille Packard Children's Hospital

Palo Alto, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Pamela Flood, MD, MA; Stanford University

  Study Documents (Full-Text)

Documents provided by Pamela Flood, Stanford University:

Study Protocol  [PDF] February 11, 2020

Statistical Analysis Plan  [PDF] September 8, 2021

More Information

Publications:

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.

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.

• 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
• Results First Posted: November 4, 2021
• Last Update Posted: November 4, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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