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The OBstetric Lidocaine Patch (OBLido) Trial (OBLido)

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ClinicalTrials.gov Identifier: NCT03810235
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Transdermal Lidocaine Patch Drug: Transdermal Hydrocolloid Placebo Patch Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-center, single blind, randomized controlled trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transdermal Lidocaine Patch for Post-Cesarean Pain Control for Women With Obesity: a Single-blind Randomized Controlled Trial
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Transdermal Lidocaine Patch
Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.
Drug: Transdermal Lidocaine Patch
Transdermal Lidocaine Patch
Other Names:
  • Actavis US
  • NDC 0591-3525-30

Placebo Comparator: Transdermal Hydrocolloid Placebo Patch
Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.
Drug: Transdermal Hydrocolloid Placebo Patch
hydrocolloid placebo patches
Other Names:
  • DuoDerm
  • ConvaTec




Primary Outcome Measures :
  1. Total dose of opioids received in the first 24 hours following Cesarean [ Time Frame: two years ]
    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 Outcome Measures :
  1. Post-operative pain score at 24 hours post-operatively [ Time Frame: one year ]
    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. The median NRS score at 24 hours will be compared between the two groups.


Other Outcome Measures:
  1. Frequency of patient-reported opioid-related side effects [ Time Frame: two years ]

    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. Incidence of complications of lidocaine use [ Time Frame: two years ]

    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. Post-operative anti-emetic use and number of recorded episodes of emesis. [ Time Frame: two years ]
    This will be reported as dichotomous "Yes/No" outcomes for emesis and if it occurs, the number of events will be reported.

  4. Return of bowel function [ Time Frame: two years ]
    Return of bowel function (measured in hours from completion of surgery to passage of flatus) Measured in hours from completion of surgery to passage of flatus. This will be reported as a continuous variable for the number of hours following surgery to flatus

  5. Length of hospital stay [ Time Frame: two years ]
    Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge

  6. Time to first rescue opioid analgesic medication [ Time Frame: two years ]
    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.

  7. Total dose of opioids used in the first 48 hours post-operatively [ Time Frame: two years ]
    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

  8. Total dose of opioids during the whole hospitalization. [ Time Frame: two years ]
    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.

  9. Frequency of postoperative complications [ Time Frame: two years ]

    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)


  10. Amount of opioid prescribed at discharge [ Time Frame: two years ]
    Measured as both the number of pills and the dose of opioids.

  11. Neonatal outcome: Apgar scores [ Time Frame: two years ]
    Apgar scores are recorded on a 0-10 scale

  12. Neonatal outcomes: NICU admission and reason [ Time Frame: two years ]
    NICU admission will be documented as a dichotomous "Yes/No" outcome

  13. Neonatal outcomes: birthweight [ Time Frame: two years ]
    Birthweight will be reported in grams

  14. Neonatal outcomes: gestational age at delivery [ Time Frame: two years ]
    Gestational age at delivery will be recorded as weeks and days of gestation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810235


Contacts
Contact: Sharon Blohowiak, MS 608-417-6957 sblohowiak@wisc.edu
Contact: Jennifer Heintz, MBA (608) 417-6361 jlheintz@wisc.edu

Locations
United States, Wisconsin
UnityPoint Health-Meriter Hospital Recruiting
Madison, Wisconsin, United States, 53715
Contact: Sharon Blohowiak    608-417-6957    sblohowiak@wisc.edu   
Principal Investigator: Kathleen Antony, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Kathleen Antony, MD UW-Madison Obstetrics and Gynecology

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03810235     History of Changes
Other Study ID Numbers: Meriter IRB 2018-015
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Wisconsin, Madison:
lidocaine
patch

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action