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

NCT06617949 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: PRO00052798
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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)

Keywords

Pain conrtrol; Substance use disorder; Parturient

Outcome Measures

Primary Outcomes (1)

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

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

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

Study Arms (3)

Transverse abdominal Plane(TAP) Block with long acting Exparel

ACTIVE COMPARATOR

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.

Drug: Regional Anesthesia

Postoperative Epidural infusion for 24-36hrs

ACTIVE COMPARATOR

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.

Procedure: Epidural local anesthetic infusion

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

ACTIVE COMPARATOR

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.

Drug: Hydromorphone Patient Controlled Analgelsic

Interventions

Regional Anesthesia DRUG

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

Transverse abdominal Plane(TAP) Block with long acting Exparel

Hydromorphone Patient Controlled Analgelsic DRUG

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

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

Epidural local anesthetic infusion PROCEDURE

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

Postoperative Epidural infusion for 24-36hrs

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (2)

Froedtert Hospital Milwaukee, Wisconsin 53226

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Meredith Albrecht, MD, PhD

CONTACT

414-805-8700; maalbrecht@mcw.edu

Christopher Fadumiye, MD

CONTACT

414-805-8700; cfadumiye@mcw.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: October 1, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (2)