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

Phase 4TerminatedNCT04033562

WellSpan Health2 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Opioid-use Disorder Opioid Use Opioid Dependence

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Pain scores

Post-operative pain scores using the visual analog scale (a scale that measures pain in 1 unit increments on a scale 0-10 with 0 being "no pain at all" and 10 being "the worst pain imaginable"

Time frame: post-operative until 60 hours postpartum

Secondary Outcomes

Rescue opioid consumption

Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively

Time frame: post-operative until 60 hours postpartum

Survey of nursing staff

1-item questionnaire to assess whether nursing felt that patient benefited from therapy. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree)

Time frame: between 48-60 hours post-Cesarean delivery

Patient survey

2-item questionnaire to assess whether patient felt like she benefited from therapy and whether she would elect to use it again in a future C-section. A Likert scale will be used (strongly agree, agree, neutral, disagree, strongly disagree)

Time frame: between 48-60 hourrs post-Cesarean delivery