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

• Status: Terminated
• Trial end date: 2021-05-17
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: WellSpan Health
• Collaborators: Ambu A/S; York Opioid Collaborative; York Opioid Collaborative, Pennsylvania
• Treatments: Analgesics; Bupivacaine; Lidocaine; Menthol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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