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The OBstetric Lidocaine Patch (OBLido) Trial (OBLido)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Transdermal Lidocaine Patch
Transdermal Hydrocolloid Placebo Patch
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring lidocaine, patch

Eligibility Criteria

18 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • UnityPoint Health-Meriter Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Transdermal Lidocaine Patch

Transdermal Hydrocolloid Placebo Patch

Arm Description

Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.

Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
January 7, 2019
Last Updated
October 28, 2022
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT03810235
Brief Title
The OBstetric Lidocaine Patch (OBLido) Trial
Acronym
OBLido
Official Title
Transdermal Lidocaine Patch for Post-Cesarean Pain Control for Women With Obesity: a Single-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
lidocaine, patch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
single-center, single blind, randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transdermal Lidocaine Patch
Arm Type
Active Comparator
Arm Description
Drug: Including placebo The intervention is the post-operative application of a 5% lidocaine transdermal patch for women who have undergone Cesarean delivery.
Arm Title
Transdermal Hydrocolloid Placebo Patch
Arm Type
Placebo Comparator
Arm Description
Drug: Including placebo The intervention is the post-operative application of a hydrocolloid transdermal patch for women who have undergone Cesarean delivery.
Intervention Type
Drug
Intervention Name(s)
Transdermal Lidocaine Patch
Other Intervention Name(s)
Actavis US, NDC 0591-3525-30
Intervention Description
Transdermal Lidocaine Patch
Intervention Type
Drug
Intervention Name(s)
Transdermal Hydrocolloid Placebo Patch
Other Intervention Name(s)
DuoDerm, ConvaTec
Intervention Description
hydrocolloid placebo patches
Primary Outcome Measure Information:
Title
Total Dose of Opioids Received in the First 24 Hours Following Cesarean
Description
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.
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Post-operative Pain Score at 24 Hours Post-operatively
Description
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.
Time Frame
up to 24 hours
Other Pre-specified Outcome Measures:
Title
Number of Participants With Opioid-related Side Effects
Description
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)
Time Frame
up to 6 weeks postpartum
Title
Number of Participants With Complications of Lidocaine Use
Description
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)
Time Frame
up to 6 weeks postpartum
Title
Length of Hospital Stay
Description
Measured in hours from admission to time of discharge This will be measured in hours from the documented time of admission until discharge
Time Frame
up to 120 hours
Title
Time to First Rescue Opioid Analgesic Medication
Description
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.
Time Frame
up to 24 hours
Title
Total Dose of Opioids Used in the First 48 Hours Post-operatively
Description
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
Time Frame
up to 48 hours
Title
Total Dose of Opioids During the Whole Hospitalization.
Description
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.
Time Frame
up to 120 hours
Title
Number of Participants With Postoperative Complications
Description
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)
Time Frame
up to 120 hours
Title
Number of Opioid Pills Prescribed at Discharge
Description
The number of opioid pills prescribed at discharge
Time Frame
up to 72 hours
Title
Neonatal Outcomes: Gestational Age at Delivery
Description
Gestational age at delivery will be recorded as weeks and days of gestation
Time Frame
up to 24 hours
Title
Dose Opioids (Measured in Total Morphine Milligram Equivalents (mg) of All Pills) Prescribed at Discharge
Description
Dose opioids (measured in total morphine milligram equivalents (mg) of all pills) prescribed at discharge
Time Frame
up to 72 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Antony, MD
Organizational Affiliation
UW-Madison Obstetrics and Gynecology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UnityPoint Health-Meriter Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33451596
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.
Results Reference
derived

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The OBstetric Lidocaine Patch (OBLido) Trial

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