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

NCT ID: NCT06617949

Last Updated: 2025-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-16

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Use Disorder (SUD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transverse abdominal Plane(TAP) Block with long acting Exparel

A subset of participants (n=15) will be divided into three different arms: A.) Postoperative Epidural infusion for 24-36hrs B.) Hydromorphone Patient Controlled Analgesia (PCA) with Preservative free Morphine via epidural for 36hrs C.) Transverse abdominal Plane(TAP) Block with long acting Exparel.

Group Type ACTIVE_COMPARATOR

Regional Anesthesia

Intervention Type DRUG

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

Postoperative Epidural infusion for 24-36hrs

A subset of participants (n=15) will be divided into three different arms: A.) Postoperative Epidural infusion for 24-36hrs B.) Hydromorphone Patient Controlled Analgesia (PCA) with Preservative free Morphine via epidural for 36hrs C.) Transverse abdominal Plane(TAP) Block with long acting Exparel.

Group Type ACTIVE_COMPARATOR

Epidural local anesthetic infusion

Intervention Type PROCEDURE

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

Hydromorphone Patient Controlled Analgesia (PCA),Preservative free Morphine via epidural for 36hrs

A subset of participants (n=15) will be divided into three different arms: A.) Postoperative Epidural infusion for 24-36hrs B.) Hydromorphone Patient Controlled Analgesia (PCA) with Preservative free Morphine via epidural for 36hrs C.) Transverse abdominal Plane(TAP) Block with long acting Exparel.

Group Type ACTIVE_COMPARATOR

Hydromorphone Patient Controlled Analgelsic

Intervention Type DRUG

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

Interventions

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Regional Anesthesia

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

Intervention Type DRUG

Hydromorphone Patient Controlled Analgelsic

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

Intervention Type DRUG

Epidural local anesthetic infusion

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Christopher Fadumiye

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Froedtert Hospital Milwaukee, Wisconsin 53226

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Meredith Albrecht, MD, PhD

Role: CONTACT

414-805-8700

Christopher Fadumiye, MD

Role: CONTACT

414-805-8700

Facility Contacts

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Christopher Fadumiye

Role: primary

Meredith Albrecht, MD,PhD

Role: primary

414-805-8700

Other Identifiers

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PRO00052798

Identifier Type: -

Identifier Source: org_study_id

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