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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use Disorder (SUD)
• Intervention / Treatment: Drug: Regional Anesthesia; Procedure: Epidural local anesthetic infusion; Drug: Hydromorphone Patient Controlled Analgelsic

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Meredith Albrecht, MD, PhD; Phone Number: 414-805-8700; Email: maalbrecht@mcw.edu
• Study Contact Backup: Name: Christopher Fadumiye, MD; Phone Number: 414-805-8700; Email: cfadumiye@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Not yet recruiting
      • Froedtert Hospital
      • Contact: Meredith Albrecht, MD,PhD; Phone Number: 414-805-8700; Email: maalbrecht@mcw.edu
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Froedtert Hospital Milwaukee, Wisconsin 53226
      • Contact: Christopher Fadumiye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Regional Anesthesia; Transverse abdominal Plane(TAP) Block with long acting Exparel placed by a regional anesthesiologist.
Active Comparator: 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.	Procedure: Epidural local anesthetic infusion; Epidural group will receive pain control via a local anesthetic intermediate bolus infusion
Active Comparator: 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.	Drug: Hydromorphone Patient Controlled Analgelsic; This group will be administered epidural PCA as a modality for pain control post cesarian section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 26, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): November 5, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Substance use disorder; Parturient; Pain conrtrol
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Anesthesia and Analgesia; Anesthesia; Anesthesia, Conduction
• Other Study ID Numbers: PRO00052798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified patient data, statistical analysis and conclusions.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No