Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Regional Anesthesia, Hydromorphone Patient Controlled Analgelsic, Epidural local anesthetic infusion.
- Who it may be relevant to
- Registry conditions: Substance Use Disorder (SUD). Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications: Efficacy and Safety Outcomes.
Overview
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.
Interventions
- Drug Regional Anesthesia
Transverse abdominal Plane(TAP) Block with long acting Exparel placed by a regional anesthesiologist. - Drug Hydromorphone Patient Controlled Analgelsic
This group will be administered epidural PCA as a modality for pain control post cesarian section - Procedure Epidural local anesthetic infusion
Epidural group will receive pain control via a local anesthetic intermediate bolus infusion
Primary outcome measures
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Froedtert Hospital Milwaukee, Wisconsin 53226 — Milwaukee
- Froedtert Hospital — Milwaukee
Identifiers
NCT: NCT06617949 · PRO00052798