Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The OBstetric Lidocaine Patch (OBLido) Trial (OBLido)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE January 7, 2019
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE February 15, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03810235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 16, 2019)
  • 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)
  • 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)
  • 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.
  • 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
  • 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
  • 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.
  • 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
  • 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.
  • 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)
  • Amount of opioid prescribed at discharge [ Time Frame: two years ]
    Measured as both the number of pills and the dose of opioids.
  • Neonatal outcome: Apgar scores [ Time Frame: two years ]
    Apgar scores are recorded on a 0-10 scale
  • Neonatal outcomes: NICU admission and reason [ Time Frame: two years ]
    NICU admission will be documented as a dichotomous "Yes/No" outcome
  • Neonatal outcomes: birthweight [ Time Frame: two years ]
    Birthweight will be reported in grams
  • Neonatal outcomes: gestational age at delivery [ Time Frame: two years ]
    Gestational age at delivery will be recorded as weeks and days of gestation
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The OBstetric Lidocaine Patch (OBLido) Trial
Official Title  ICMJE Transdermal Lidocaine Patch for Post-Cesarean Pain Control for Women With Obesity: a Single-blind Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
single-center, single blind, randomized controlled trial
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Drug: Transdermal Lidocaine Patch
    Transdermal Lidocaine Patch
    Other Names:
    • Actavis US
    • NDC 0591-3525-30
  • Drug: Transdermal Hydrocolloid Placebo Patch
    hydrocolloid placebo patches
    Other Names:
    • DuoDerm
    • ConvaTec
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Transdermal Lidocaine Patch
  • 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.
    Intervention: Drug: Transdermal Hydrocolloid Placebo Patch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: pregnant women
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Sharon Blohowiak, MS 608-417-6957 sblohowiak@wisc.edu
Contact: Jennifer Heintz, MBA (608) 417-6361 jlheintz@wisc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03810235
Other Study ID Numbers  ICMJE Meriter IRB 2018-015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathleen Antony, MD UW-Madison Obstetrics and Gynecology
PRS Account University of Wisconsin, Madison
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP