Opioid-use Disorder, Opioid Use, Opioid Dependence, Opioid Abuse, Medication Assisted Treatment, Infusion Catheter, Wound, Lidopatch, Ambu ACTion, Pregnancy Related, Cesarean Section
Conditions
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 of bupivacaine or lidocaine/menthol patch after Cesarean delivery. Post-operative pain scores and opioid usage in the post-operative period will be recorded.
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 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.
Interventions
DRUGLidocaine patch
Lidocaine patch will be applied at time of Cesarean delivery for post-operative pain control.
DEVICEAmbu ACTion pump, 0.125% bupivacaine at 8cc/hr
Infusion pump will be placed at time of Cesarean delivery for post-operative pain control.
Sponsors
Ambu A/S
York Opioid Collaborative, Pennsylvania
WellSpan Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores | post-operative until 60 hours postpartum | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rescue opioid consumption | post-operative until 60 hours postpartum | Total opioid consumption in MME (morphine milligram equivalent) that patients received post-operatively |
| Survey of nursing staff | between 48-60 hours post-Cesarean delivery | 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) |
| Patient survey | between 48-60 hourrs post-Cesarean delivery | 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) |
Countries
United States
Outcome results
None listed