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

WellSpan Health

Status and phase: Terminated; Phase 4

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

Treatments: Device: Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr; Drug: Lidocaine patch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04033562

1351850

Details and patient eligibility

About

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.

Full 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 of two study groups. The first group will receive a Lidocaine/Menthol patch at the time of her Cesarean delivery, the second will receive placement of the Ambu ACTion infusion pain system at the time of the C-section. This device will be set up to infuse 0.125% of bupivacaine for 48-60hrs postoperatively at a rate of 8cc/hr.

Enrollment: 2 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 2 patient groups

Lidoderm patch

Active Comparator group

Description:

Participants will receive a topical 3.6% Lidocaine/1.25% Menthol patch at the time of their Cesarean section. Patches will be replaced every 12 hours for a total of 60 hours.

Treatment:

Drug: Lidocaine patch

Infusion pump

Active Comparator group

Description:

Participants will undergo placement of Ambu ACTion drug delivery system at the time of Cesarean delivery. 0.125% of bupivacaine will be infused at a rate of 8cc/hr for a total of 48-60hrs post-operatively.

Treatment:

Device: Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr