Prevention of Persistent Opioid Use in Mothers

Opioid Use Clinical Trial

Official title:

Prevention of Persistent Pain and Opioid Use in Mothers - POMS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03472521
• Other study ID #: IRB-43964
• Status: Completed
• Phase: Phase 4
• Start date: September 17, 2018
• Est. completion date: April 10, 2021

Study information

• Verified date: April 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 10, 2021
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Opiate use disorder

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Opioid Use
• Postpartum Disorder
• Puerperal Disorders

Intervention

Drug:
• Gabapentin
Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.
• Placebo
Placebo to match gabapentin

Locations

Country	Name	City	State
United States	Lucille Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fatigue	PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.	12 weeks
Other	Depression	PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.	12 weeks
Other	Anxiety	PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.	12 weeks
Other	PROMIS Physical Function	PROMIS Physical Function questionnaire will be used to assess fatigue as a modifier of the above outcomes.	12 weeks after delivery
Other	Steps	Fitness tracker measured steps	12 weeks after delivery
Other	Sleep	Fitness tracker measured sleep	12 weeks after delivery
Other	Heart Rate	Fitness tracker measured heart rate	12 weeks after delivery
Primary	Time to Opioid Cessation as a Measure of Opioid Utilization		Up to 12 weeks
Secondary	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).	12 weeks
Secondary	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.	12 weeks