Prevention of Persistent Opioid Use in Mothers

NCT03472521 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB-43964
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Postpartum Disorder; Chronic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Time to Opioid Cessation as a Measure of Opioid Utilization

  Up to 12 weeks

Secondary Outcomes (2)

• Pain Report

  12 weeks

• Functional Recovery

  12 weeks

Other Outcomes (7)

• Fatigue

  12 weeks

• Depression

  12 weeks

• Anxiety

  12 weeks

Study Arms (2)

Gabapentin

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Gabapentin DRUG

Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.

Also known as: Active

Gabapentin

Placebo DRUG

Placebo to match gabapentin

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Opiate use disorder

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucille Packard Children's Hospital

Palo Alto, California, 94305, United States

Location

Related Publications (3)

• 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.

  PMID: 28926443 BACKGROUND

• 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.

  PMID: 30032880 BACKGROUND

• Fowler C, Chu AW, Guo N, Ansari JR, Shafer SL, Flood PD. Outpatient Treatment With Gabapentin in Women With Severe Acute Pain After Cesarean Delivery Is Ineffective: A Randomized, Double-Blind, Placebo-Controlled Trial. Anesth Analg. 2023 Jun 1;136(6):1122-1132. doi: 10.1213/ANE.0000000000006429. Epub 2023 Apr 12.

  PMID: 37043404 DERIVED

MeSH Terms

Conditions

Puerperal Disorders

Interventions

Gabapentin; Exercise

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Pamela Flood, MD, MA
• Organization: Stanford University

pflood@stanford.edu

201-370-3933

Study Officials

• Pamela Flood, MD, MA

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomization table will be used by the research pharmacy and study drug will be prepared in numbered bottles.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomized

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 21, 2018
• Study Start: September 17, 2018
• Primary Completion: July 2, 2020
• Study Completion: April 10, 2021
• Last Updated: May 5, 2022
• Results First Posted: November 4, 2021

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)