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

Early Phase 1

Recruiting

• Conditions: Substance Use Disorder (SUD)
• Interventions: Drug: Hydromorphone Patient Controlled Analgelsic; Drug: Regional Anesthesia; Procedure: Epidural local anesthetic infusion

• Registration Number: NCT06617949
• Lead Sponsor: Medical College of Wisconsin

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-26
• Study First Posted: 2024-10-01
• Study Start: 2025-01-16
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-29
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydromorphone Patient Controlled Analgesia (PCA),Preservative free Morphine via epidural for 36hrs	Hydromorphone Patient Controlled Analgelsic	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.
Transverse abdominal Plane(TAP) Block with long acting Exparel	Regional Anesthesia	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.
Postoperative Epidural infusion for 24-36hrs	Epidural local anesthetic infusion	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with Change in pain assessment scores from baseline post surgery	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.

Trial Locations

Locations (2)

Froedtert Hospital Milwaukee, Wisconsin 53226; 🇺🇸 Milwaukee, Wisconsin, United States

Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States