Prevention of Persistent Opioid Use in Mothers

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03472521
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 2
• Actual Duration (Months): 30.8
• Patients Per Site Per Month: 2.5

Study Details

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
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blind randomizedDouble 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: Sep 17, 2018
• Actual Primary Completion Date: Jul 2, 2020
• Actual Study Completion Date: Apr 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 Names: 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 [Up to 12 weeks]

Secondary Outcome Measures

1. Pain Report [12 weeks]

   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).

2. Functional Recovery [12 weeks]

   Functional recovery was assessed as the number of weeks after delivery until participants reported they were able to return to pre-delivery function.

Other Outcome Measures

1. Fatigue [12 weeks]

   PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

2. Depression [12 weeks]

   PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

3. Anxiety [12 weeks]

   PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.

4. PROMIS Physical Function [12 weeks after delivery]

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

5. Steps [12 weeks after delivery]

   Fitness tracker measured steps

6. Sleep [12 weeks after delivery]

   Fitness tracker measured sleep

7. Heart Rate [12 weeks after delivery]

   Fitness tracker measured heart rate

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Opiate use disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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)

• Study Protocol - Feb 11, 2020
• Statistical Analysis Plan - Sep 8, 2021

More Information

Publications

• 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.
• 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.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT03472521
• Other Study ID Numbers: IRB-43964
• First Posted: Mar 21, 2018
• Last Update Posted: May 5, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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; Gabapentin

Study Results

Participant Flow

Arm/Group Title	Gabapentin	Control
Arm/Group Description	Gabapentin 300 mg capsules, 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, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Period Title: Overall Study
STARTED	41	37
Received Allocated Intervention	41	37
COMPLETED	35	34
NOT COMPLETED	6	3

Baseline Characteristics

Arm/Group Title	Gabapentin	Control	Total
Arm/Group Description	Gabapentin 300 mg capsules, 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, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.	Total of all reporting groups
Overall Participants	41	37	78
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	41 100%	37 100%	78 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	41 100%	37 100%	78 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	14 34.1%	11 29.7%	25 32.1%
Not Hispanic or Latino	27 65.9%	26 70.3%	53 67.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
African American	0 0%	2 5.4%	2 2.6%
Asian	12 29.3%	13 35.1%	25 32.1%
Caucasian	15 36.6%	13 35.1%	28 35.9%
Pacific Islander	1 2.4%	0 0%	1 1.3%
Other	10 24.4%	7 18.9%	17 21.8%
Unknown or Not Reported	3 7.3%	2 5.4%	5 6.4%
Region of Enrollment (Count of Participants)
United States	41 100%	37 100%	78 100%

Outcome Measures

1. Primary Outcome

Title	Time to Opioid Cessation as a Measure of Opioid Utilization
Time Frame	Up to 12 weeks

Outcome Measure Data

Analysis Population Description

Participants who completed the protocol are included in the analysis.

Arm/Group Title	Gabapentin	Control
Arm/Group Description	Gabapentin 300 mg capsules, 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, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Measure Participants	35	34
Median (Inter-Quartile Range) [weeks]	2	2

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed the protocol are included in the analysis.

Arm/Group Title	Gabapentin	Control
Arm/Group Description	Gabapentin 300 mg capsules, 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, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Measure Participants	35	34
Median (Inter-Quartile Range) [weeks]	7	12

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who completed the protocol are included in the analysis.

Arm/Group Title	Gabapentin	Control
Arm/Group Description	Gabapentin 300 mg capsules, 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, prescribed at a starting dose of 1 capsule three times a day and titrated on the recommendation of a chronic pain specialist.
Measure Participants	35	34
Median (Inter-Quartile Range) [weeks]	8	11

4. Other Pre-specified Outcome

Title	Fatigue
Description	PROMIS Fatigue 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Other Pre-specified Outcome

Title	Depression
Description	PROMIS Depression 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Other Pre-specified Outcome

Title	Anxiety
Description	PROMIS Anxiety 4 questionnaire will be used to assess fatigue as a modifier of the above outcomes.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Other Pre-specified Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Other Pre-specified Outcome

Title	Steps
Description	Fitness tracker measured steps
Time Frame	12 weeks after delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Other Pre-specified Outcome

Title	Sleep
Description	Fitness tracker measured sleep
Time Frame	12 weeks after delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Other Pre-specified Outcome

Title	Heart Rate
Description	Fitness tracker measured heart rate
Time Frame	12 weeks after delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Gabapentin		Control
Arm/Group 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. Gabapentin: Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.		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: Placebo to match gabapentin
All Cause Mortality
	Gabapentin		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/37 (0%)
Serious Adverse Events
	Gabapentin		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/37 (0%)
Other (Not Including Serious) Adverse Events
	Gabapentin		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.