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Clinical Trials/NCT06617949
NCT06617949
Recruiting
Early Phase 1

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

Medical College of Wisconsin2 sites in 1 country20 target enrollmentJanuary 16, 2025

Overview

Phase
Early Phase 1
Intervention
Regional Anesthesia
Conditions
Substance Use Disorder (SUD)
Sponsor
Medical College of Wisconsin
Enrollment
20
Locations
2
Primary Endpoint
Number of participants with Change in pain assessment scores from baseline post surgery
Status
Recruiting
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2025
End Date
December 1, 2028
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christopher Fadumiye

Assistant Professor

Medical College of Wisconsin

Eligibility 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.

Arms & Interventions

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.

Intervention: Regional Anesthesia

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.

Intervention: Epidural local anesthetic 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.

Intervention: Hydromorphone Patient Controlled Analgelsic

Outcomes

Primary Outcomes

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

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

Study Sites (2)

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