Recruiting

Early Phase 1

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

Sponsor:

Medical College of Wisconsin

Code:

NCT06617949

Conditions

Substance Use Disorder (SUD)

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Regional Anesthesia

Hydromorphone Patient Controlled Analgelsic

Epidural local anesthetic infusion

Study Details

Brief summary:

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.

Conditions

Substance Use Disorder (SUD)

Study ID

NCT06617949

Start date

Jan 16, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

active comparator: Postoperative Epidural infusion for 24-36hrs

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

Interventions

Regional Anesthesia

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

Hydromorphone Patient Controlled Analgelsic

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

Epidural local anesthetic infusion

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

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Meredith Albrecht, MD, PhD

414-805-8700 maalbrecht@mcw.edu

Christopher Fadumiye, MD

414-805-8700 cfadumiye@mcw.edu

Locations

Froedtert Hospital Milwaukee, Wisconsin 53226

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Keywords

Pain conrtrol
Substance use disorder
Parturient

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-10-23.