The OBstetric Lidocaine Patch (OBLido) Trial

• Status: Completed
• Trial end date: 2019-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Lidocaine

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