Status:
COMPLETED
The OBstetric Lidocaine Patch (OBLido) Trial
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Pain, Postoperative
Eligibility:
FEMALE
18-59 years
Phase:
PHASE4
Brief 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-Ma...
Detailed Description
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. O...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03810235
Start Date
February 15 2019
End Date
November 30 2019
Last Update
August 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UnityPoint Health-Meriter Hospital
Madison, Wisconsin, United States, 53715