The OBstetric Lidocaine Patch (OBLido) Trial
Completed · Phase 4 · Has a placebo group
Conditions studied: Pain, Postoperative
In brief
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.
Key facts
- Study ID
- NCT03810235
- Run by
- University of Wisconsin, Madison
- People needed
- 66
- Starts
- 2019-02-15
- Expected to finish
- 2019-11-30
- Last updated by the study team
- 2025-08-22
Who can join
Age: 18 and older, up to 59. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UnityPoint Health-Meriter Hospital — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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