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Completed

NCT Number: NCT03810235

The OBstetric Lidocaine Patch (OBLido) Trial

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.

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Key information

Age range

18 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UnityPoint Health-Meriter Hospital

Madison, Wisconsin, 53715, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transdermal Lidocaine Patch

Drug

Transdermal Lidocaine Patch

Other names: Actavis US, NDC 0591-3525-30

Transdermal Hydrocolloid Placebo Patch

Drug

hydrocolloid placebo patches

Other names: DuoDerm, ConvaTec

Primary outcomes

  1. Total Dose of Opioids Received in the First 24 Hours Following Cesarean

    Time frame: up to 24 hours

    The total dose of opioids received in the first 24 hours following Cesarean delivery measured as oral morphine equivalents. This total dose will be calculated for every subject in the study, and the average and standard deviation (or appropriate non-parametric values if the data is not normally distributed) will be compared between the subjects randomized to the intervention arm and the placebo arm of the study.

Secondary outcomes

  1. Post-operative Pain Score at 24 Hours Post-operatively

    Time frame: up to 24 hours

    The post-operative pain score at 24 hours post-operatively will be measured using the numeric rating scale (NRS), wherein subjects rate pain on a 0-10 scale (10 meaning the most pain and 0 meaning no pain). The median NRS score at 24 hours will be compared between the two groups.

Other outcomes

  1. Number of Participants With Opioid-related Side Effects

    Time frame: up to 6 weeks postpartum

    Patient-reported opioid-related side effects include pruritis, constipation, nausea, and mental clouding.

    Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)

  2. Number of Participants With Complications of Lidocaine Use

    Time frame: up to 6 weeks postpartum

    Complications of lidocaine use include local burning, nausea, dizziness, drowsiness, serious skin reactions such as blistering, confusion, blurred vision, ringing in the ears, and allergies and hypersensitivities.

    Definition: Patient reported side effects which will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)

  3. Length of Hospital Stay

    Time frame: up to 120 hours

    Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge

  4. Time to First Rescue Opioid Analgesic Medication

    Time frame: up to 24 hours

    Measured in minutes from arrival in the post-anesthesia care unit (PACU) until the first as needed opioid dose is administered. This will be recorded in minutes from the time of the surgery completion (surgery end time) until the first opioid analgesic medication is administered. Data in table is noted in hours.

  5. Total Dose of Opioids Used in the First 48 Hours Post-operatively

    Time frame: up to 48 hours

    All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received in 48 hours following surgery calculated as oral morphine equivalents

  6. Total Dose of Opioids During the Whole Hospitalization.

    Time frame: up to 120 hours

    All opioid doses will be converted into oral morphine equivalents. This will be recorded as the total dose of opioids received during the hospitalization (following surgery) calculated as oral morphine equivalents.

  7. Number of Participants With Postoperative Complications

    Time frame: up to 120 hours

    Includes urinary tract infections, thromboembolic events, pneumonia, postpartum blood transfusions, falls, myocardial infarctions.

    These events will be reported as frequencies of occurrence. (These will be reported as dichotomous "Yes/No" outcomes for each side effect)

  8. Number of Opioid Pills Prescribed at Discharge

    Time frame: up to 72 hours

    The number of opioid pills prescribed at discharge

  9. Neonatal Outcomes: Gestational Age at Delivery

    Time frame: up to 24 hours

    Gestational age at delivery will be recorded as weeks and days of gestation

  10. Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge

    Time frame: up to 72 hours

    Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Transdermal Lidocaine Patch for Post-Cesarean Pain Control for Women With Obesity: a Single-blind Randomized Controlled Trial

Acronym: OBLido

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2019
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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