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NCT Number: NCT06617949

Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.

The purpose of this study is to investigate the efficacy of three different modalities of post-operative pain control in parturient with opioid use disorders. The investigators aim to determine whether the different approach utilized show better outcomes with pain management and if there are any association with reduction of symptoms of anxiety, depression, and overall well-being.

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Key information

Conditions

Substance Use Disorder (SUD) Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Froedtert Hospital, Milwaukee, Wisconsin, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inclusion criteria include being a parturient with Substance use disorder (SUD) and age 18-35

Exclusion criteria

  • Exclusion criteria include having a diagnosed medical condition(allergies to medication, pathology such as severe aortic stenosis excluding patients from receiving an epidural etc) that will exempt patient from intervention arm of the study.

Treatment and study plan

Regional Anesthesia

Drug

Transverse abdominal Plane(TAP) Block with long acting Exparel placed by a regional anesthesiologist.

Hydromorphone Patient Controlled Analgelsic

Drug

This group will be administered epidural PCA as a modality for pain control post cesarian section

Epidural local anesthetic infusion

Procedure

Epidural group will receive pain control via a local anesthetic intermediate bolus infusion

Primary outcomes

  1. Number of participants with Change in pain assessment scores from baseline post surgery

    Time frame: immediately after the study intervention and up to post op day 2

    Number of participants with significant change in pain assessment scores and any association with reduction of symptoms of anxiety, depression, and overall well-being.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Fadumiye, MD

CONTACT

[email protected]

414-805-8700

Meredith Albrecht, MD, PhD

CONTACT

[email protected]

414-805-8700

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Official study title

Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications: Efficacy and Safety Outcomes.

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 1, 2024
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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