The OBstetric Lidocaine Patch (OBLido) Trial
Status: | Recruiting |
---|---|
Conditions: | Post-Surgical Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - 59 |
Updated: | 2/21/2019 |
Start Date: | February 15, 2019 |
End Date: | March 31, 2020 |
Contact: | Sharon Blohowiak, MS |
Email: | sblohowiak@wisc.edu |
Phone: | 608-417-6957 |
Transdermal Lidocaine Patch for Post-Cesarean Pain Control for Women With Obesity: a Single-blind Randomized Controlled Trial
This study will be a single-center, single blind, randomized controlled trial. The study will
be conducted at UnityPoint-Health Meriter Hospital under investigators from the University of
Wisconsin-Madison. Obstetric patients with prepregnancy obesity undergoing a Cesarean
delivery at UnityPoint-Health Meriter will be eligible.
be conducted at UnityPoint-Health Meriter Hospital under investigators from the University of
Wisconsin-Madison. Obstetric patients with prepregnancy obesity undergoing a Cesarean
delivery at UnityPoint-Health Meriter will be eligible.
The purpose of this study is to determine whether transdermal lidocaine administered at the
time of Cesarean delivery and for 12 hours postoperatively will reduce the total dose of
opioids received. Our hypothesis is that a lidocaine patch will reduce the total dose of
opioids received in the immediate 24 hours post-delivery. Secondary outcomes will include
patient self-reported pain scores, patient-reported incidence of side effects, such as
pruritis, development of objective complications, such as serious skin reactions (examples
are acute generalized exanthematous pustolosis, Stevens-Johnson syndrome, and toxic epidermal
necrolysis), hypersensitivity, nausea, and nervousness. Other outcomes collected will include
length of stay, time to first rescue analgesic medication, total dose of opioids in 48 hours,
use of supplemental oxygen during hospitalization, total dose of opioids during
hospitalization, breastfeeding rates, both exclusive and in combination with formula use,
amount of opioid prescribed at discharge and whether refills were requested or administered,
rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen
scores. Neonatal outcomes such as five-minute Apgar scores and development of adverse
outcomes will also be collected.
time of Cesarean delivery and for 12 hours postoperatively will reduce the total dose of
opioids received. Our hypothesis is that a lidocaine patch will reduce the total dose of
opioids received in the immediate 24 hours post-delivery. Secondary outcomes will include
patient self-reported pain scores, patient-reported incidence of side effects, such as
pruritis, development of objective complications, such as serious skin reactions (examples
are acute generalized exanthematous pustolosis, Stevens-Johnson syndrome, and toxic epidermal
necrolysis), hypersensitivity, nausea, and nervousness. Other outcomes collected will include
length of stay, time to first rescue analgesic medication, total dose of opioids in 48 hours,
use of supplemental oxygen during hospitalization, total dose of opioids during
hospitalization, breastfeeding rates, both exclusive and in combination with formula use,
amount of opioid prescribed at discharge and whether refills were requested or administered,
rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen
scores. Neonatal outcomes such as five-minute Apgar scores and development of adverse
outcomes will also be collected.
Inclusion Criteria:
- Maternal age greater than or equal to 18
- Prepregnancy body mass index greater than or equal to 30 kg/m2 or ≥35 kg/m2 at
delivery if no prepregnancy/ early pregnancy weight available
- Singleton or multifetal pregnancy
- Able to receive neuraxial analgesia
- Planned/ scheduled Cesarean delivery OR non-urgent Cesarean delivery with adequate
time to consider and consent to the study
- Gestational age greater or equal to 32 weeks
Exclusion Criteria:
- Known hypersensitivity to lidocaine or colloid patch (defined as a history of a
reaction or allergy to lidocaine (injectable, intravenous, or transdermal) or
hydrocolloid patch reported by patient or documented in the medical record) or patient
report
- Contraindication to regional analgesia
- Positive urine drug screen at admission to the hospital, if ordered for clinical
purposes.
- Current opioid use or opioid use disorder per patient report or documented in the
medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery)
- Chronic opioid use or opioid use disorder, either patient reported or documented in
the medical record or the ePDMP (reviewed by PI 1-14 days prior to surgery), defined
as opioid use on most days for >3 months
- Planned Cesarean hysterectomy (excluded due to anticipated blood loss and alternative
pain control measures, possible prolonged intubation)
- Planned vertical midline incision
- Presence of renal dysfunction precluding the use of NSAIDs
- Ischemic heart disease, congestive heart failure, or cardiomyopathy of pregnancy
- Coagulopathy
- Planned discharge from the hospital less than 24 hours postpartum
We found this trial at
1
site
202 South Park Street
Madison, Wisconsin 53715
Madison, Wisconsin 53715
Principal Investigator: Kathleen Antony, MD
Phone: 608-417-6957
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