Phase 4
N=63
The OBstetric Lidocaine Patch (OBLido) Trial
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT03810235 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Total Dose of Opioids Received in the First 24 Hours Following Cesarean — 87; 83.9 MME, morphine milligram equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Transdermal Lidocaine Patch (Drug); Transdermal Hydrocolloid Placebo Patch (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Dose of Opioids Received in the First 24 Hours Following Cesarean |
87; 83.9 | — |
| SECONDARY Post-operative Pain Score at 24 Hours Post-operatively |
3.0; 3.5; 3.0; 3.0; 4.0; 4.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03810235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.