The Analgesic Efficacy of Continuous Sub-fascial Bupivacaine Infusion and Lidocaine Patches in Post-cesarean Patients With Opiate Use Disorder: A Comparative Efficacy Analysis

Stopped early · Phase 4

Conditions studied: Opioid-use Disorder, Opioid Use, Opioid Dependence, Opioid Abuse, Medication Assisted Treatment, Infusion Catheter, Wound, Lidopatch, Ambu ACTion, Pregnancy Related, Cesarean Section

In brief

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 of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.

Key facts

Study ID

NCT04033562

Run by

WellSpan Health

People needed

2

Starts

2020-01-15

Expected to finish

2021-05-17

Last updated by the study team

2021-06-07

Who can join

Age: 18 and older, up to 100. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• WellSpan Health York Hospital — York, Pennsylvania, United States

Full record on ClinicalTrials.gov

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