Clinical trial NCT03810235: The OBstetric Lidocaine Patch (OBLido) Trial
Official title: Transdermal Lidocaine Patch for Post-Cesarean Pain Control for Women With Obesity: a Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: lidocaine
patch
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, single blind, randomized controlled trial
Primary purpose: TREATMENT

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-Madison. Obstetric patients with prepregnancy obesity undergoing a Cesarean delivery at UnityPoint-Health Meriter will be eligible.

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. Our hypothesis is that a lidocaine patch will reduce the total dose of opioids received in the immediate 24 hours post-delivery. Secondary outcomes will include patient self-reported pain scores, patient-reported incidence of side effects, such as pruritis, development of objective complications, such as serious skin reactions (examples are acute generalized exanthematous pustolosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis), hypersensitivity, nausea, and nervousness. Other outcomes collected will include length of stay, time to first rescue analgesic medication, total dose of opioids in 48 hours, use of supplemental oxygen during hospitalization, total dose of opioids during hospitalization, breastfeeding rates, both exclusive and in combination with formula use, amount of opioid prescribed at discharge and whether refills were requested or administered, rates of chronic pain at six weeks postpartum, and six week Edinburgh Depression Screen scores. Neonatal outcomes such as five-minute Apgar scores and development of adverse outcomes will also be collected.

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

Primary outcomes:
measure: Total Dose of Opioids Received in the First 24 Hours Following Cesarean
timeFrame: up to 24 hours
Secondary outcomes:
measure: Post-operative Pain Score at 24 Hours Post-operatively
timeFrame: up to 24 hours
Other outcomes:
measure: Number of Participants With Opioid-related Side Effects
timeFrame: up to 6 weeks postpartum
measure: Number of Participants With Complications of Lidocaine Use
timeFrame: up to 6 weeks postpartum
measure: Length of Hospital Stay
timeFrame: up to 120 hours
measure: Time to First Rescue Opioid Analgesic Medication
timeFrame: up to 24 hours
measure: Total Dose of Opioids Used in the First 48 Hours Post-operatively
timeFrame: up to 48 hours
measure: Total Dose of Opioids During the Whole Hospitalization.
timeFrame: up to 120 hours
measure: Number of Participants With Postoperative Complications
timeFrame: up to 120 hours
measure: Number of Opioid Pills Prescribed at Discharge
timeFrame: up to 72 hours
measure: Neonatal Outcomes: Gestational Age at Delivery
timeFrame: up to 24 hours
measure: Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge
timeFrame: up to 72 hours
Locations:
city: Madison
country: United States
facility: UnityPoint Health-Meriter Hospital
state: Wisconsin
Study officials:
affiliation: UW-Madison Obstetrics and Gynecology
name: Kathleen Antony, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Antony KM, Adams JH, Jacques L, Hetzel S, Chappell RJ, Gnadt SE, Tevaarwerk AJ. Lidocaine patches for postcesarean pain control in obese women: a pilot randomized controlled trial. Am J Obstet Gynecol MFM. 2021 Jan;3(1):100281. doi: 10.1016/j.ajogmf.2020.100281. Epub 2020 Nov 26.