Status:
TERMINATED
The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis
Lead Sponsor:
WellSpan Health
Collaborating Sponsors:
Ambu A/S
York Opioid Collaborative, Pennsylvania
Conditions:
Opioid-use Disorder
Opioid Use
Eligibility:
FEMALE
18-100 years
Phase:
PHASE4
Brief Summary
Pregnant women with a history of opioid use disorder, chronic opioid use or those who are on medication assisted treatment will be randomly assigned to receive either a sub-fascial continuous infusion...
Detailed Description
Pregnant women 18 years or older with a history of chronic opioid use, opioid use disorder or women on medication assisted treatment (MAT), will be enrolled in the study and randomly assigned to one o...
Eligibility Criteria
Inclusion
- Pregnancy
- undergoing a Cesarean delivery via a transverse incision at York Hospital labor and delivery
- Documented history of chronic opioid use or documented OUD, or currently utilizing medically assisted treatment (MAT)
Exclusion
- Patients with a history of clinically significant cardiovascular, hepatic, or renal disease
- Non-English speaking
- Allergy to bupivacaine, lidocaine, zinc, silver or menthol
- Unable to consent, due to lack of decisional capacity or need for emergent Cesarean delivery
- History of glucose-6-phosphate deficiency
- Use of anti-arrhythmic drugs such as tocainide or mexiletine
Key Trial Info
Start Date :
January 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04033562
Start Date
January 15 2020
End Date
May 17 2021
Last Update
June 7 2021
Active Locations (1)
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1
WellSpan Health York Hospital
York, Pennsylvania, United States, 17403