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

Conditions

• Substance Use Disorder (SUD)

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

• Regional Anesthesia — DRUG
  Transverse abdominal Plane(TAP) Block with long acting Exparel placed by a regional anesthesiologist.
• Hydromorphone Patient Controlled Analgelsic — DRUG
  This group will be administered epidural PCA as a modality for pain control post cesarian section
• Epidural local anesthetic infusion — PROCEDURE
  Epidural group will receive pain control via a local anesthetic intermediate bolus infusion

Study Details

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.

Key Dates

Start date

Jan 16, 2025

Status verified

Oct 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

20 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• 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.

Primary Outcome Measure

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 ]

Central Contacts

• Meredith Albrecht, MD, PhD
  414-805-8700
  [email protected]
• Christopher Fadumiye, MD
  414-805-8700
  [email protected]

Locations (2)

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