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

Medical College of Wisconsin

Status and phase: Enrolling; Early Phase 1

Conditions: Substance Use Disorder (SUD)

Treatments: Drug: Regional Anesthesia; Drug: Hydromorphone Patient Controlled Analgelsic; Procedure: Epidural local anesthetic infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06617949

PRO00052798

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 3 patient groups

Transverse abdominal Plane(TAP) Block with long acting Exparel

Active Comparator group

Description:

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.

Treatment:

Drug: Regional Anesthesia

Postoperative Epidural infusion for 24-36hrs

Active Comparator group

Description:

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.

Treatment:

Procedure: Epidural local anesthetic infusion

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

Active Comparator group

Description:

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.

Treatment:

Drug: Hydromorphone Patient Controlled Analgelsic