Substance Use Disorder (SUD)Early Phase 1NCT06617949
Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.
A Early Phase 1 study testing Regional Anesthesia and Epidural local anesthetic infusion in people with Substance Use Disorder (SUD), run by Medical College of Wisconsin at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- Regional Anesthesia and Epidural local anesthetic infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Jan 2025to 31 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion criteria include being a parturient with Substance use disorder (SUD) and age 18-35
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Froedtert Hospital Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin, 53226
Christopher Fadumiye
- Not yet recruiting
Froedtert Hospital
Milwaukee, Wisconsin, 53226
Meredith Albrecht, MD,PhD, 414-805-8700, maalbrecht@mcw.edu
About this study
Official title: Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications: Efficacy and Safety Outcomes.
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.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- Regional Anesthesia, Hydromorphone Patient Controlled Analgelsic, Epidural local anesthetic infusion
- Keywords
- Pain conrtrol, Substance use disorder, Parturient
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional AnesthesiaDrug
Transverse abdominal Plane(TAP) Block with long acting Exparel placed by a regional anesthesiologist.
Hydromorphone Patient Controlled AnalgelsicDrug
This group will be administered epidural PCA as a modality for pain control post cesarian section
Epidural local anesthetic infusionProcedure or surgery
Epidural group will receive pain control via a local anesthetic intermediate bolus infusion
| Study group | Role | What they receive |
|---|---|---|
| Transverse abdominal Plane(TAP) Block with long acting Exparel | Active comparator | 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. Receives: Drug: Regional Anesthesia |
| Postoperative Epidural infusion for 24-36hrs | Active comparator | 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. Receives: Procedure: Epidural local anesthetic infusion |
| Hydromorphone Patient Controlled Analgesia (PCA),Preservative free Morphine via epidural for 36hrs | Active comparator | 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. Receives: Drug: Hydromorphone Patient Controlled Analgelsic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Change in pain assessment scores from baseline post surgery
Number of participants with significant change in pain assessment scores and any association with reduction of symptoms of anxiety, depression, and overall well-being.
Measured: immediately after the study intervention and up to post op day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start16 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Fadumiye, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617949
- Sponsor's protocol ID
- PRO00052798
- Status last verified
- Nov 2026
- First submitted
- 19 Sep 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified patient data, statistical analysis and conclusions.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications: Efficacy and Safety Outcomes.
- ClinicalTrials.gov ID
- NCT06617949
- Acronym / sponsor ID
- PRO00052798
- Conditions
- Substance Use Disorder (SUD)
- Keywords
- Pain conrtrol, Substance use disorder, Parturient
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transverse abdominal Plane(TAP) Block with long acting Exparel | Active comparator | Drug: Regional AnesthesiaA 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 | Active comparator | Procedure: Epidural local anesthetic infusionA 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. |
| Hydromorphone Patient Controlled Analgesia (PCA),Preservative free Morphine via epidural for 36hrs | Active comparator | Drug: Hydromorphone Patient Controlled AnalgelsicA 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inclusion criteria include being a parturient with Substance use disorder (SUD) and age 18-35
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional AnesthesiaTransverse abdominal Plane(TAP) Block with long acting Exparel placed by a regional anesthesiologist. | Drug | Transverse abdominal Plane(TAP) Block with long acting Exparel |
| Hydromorphone Patient Controlled AnalgelsicThis group will be administered epidural PCA as a modality for pain control post cesarian section | Drug | Hydromorphone Patient Controlled Analgesia (PCA),Preservative free Morphine via epidural for 36hrs |
| Epidural local anesthetic infusionEpidural group will receive pain control via a local anesthetic intermediate bolus infusion | Procedure or surgery | Postoperative Epidural infusion for 24-36hrs |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified patient data, statistical analysis and conclusions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Regional Anesthesia and Epidural local anesthetic infusion in people with Substance Use Disorder (SUD), run by Medical College of Wisconsin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meredith Albrecht, MD, PhD (414-805-8700, maalbrecht@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.