Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT03810235
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT03810235
Study Brief:
Protocol Section:
NCT03810235