The OBstetric Lidocaine Patch (OBLido) Trial

NCT03810235 | Completed Phase 4 Results DMC FDA Drug

• 4 other identifiers: Meriter IRB 2018-015A532860SMPH/OBSTET & GYNECOL/OBSTET2019-0139
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

lidocaine; patch

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 hours

Secondary Outcomes (1)

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

  up to 24 hours

Other Outcomes (10)

• Number of Participants With Opioid-related Side Effects

  up to 6 weeks postpartum

• Number of Participants With Complications of Lidocaine Use

  up to 6 weeks postpartum

• Length of Hospital Stay

  up to 120 hours

Study Arms (2)

Transdermal Lidocaine Patch

ACTIVE COMPARATOR

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 Hydrocolloid Placebo Patch

PLACEBO COMPARATOR

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

Interventions

Transdermal Lidocaine Patch DRUG

Transdermal Lidocaine Patch

Also known as: Actavis US, NDC 0591-3525-30

Transdermal Lidocaine Patch

Transdermal Hydrocolloid Placebo Patch DRUG

hydrocolloid placebo patches

Also known as: DuoDerm, ConvaTec

Transdermal Hydrocolloid Placebo Patch

Eligibility Criteria

• Age: 18 Years - 59 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UnityPoint Health-Meriter Hospital

Madison, Wisconsin, 53715, United States

Location

Related Publications (1)

• 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.

  PMID: 33451596 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Results Point of Contact

• Title: Kathleen M. Antony, M.D, M.S.C.I
• Organization: School of Medicine and Public Health University of Wisconsin-Madison

kantony@wisc.edu

608-417-6099

Study Officials

• Kathleen Antony, MD

  UW-Madison Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-center, single blind, randomized controlled trial

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 18, 2019
• Study Start: February 15, 2019
• Primary Completion: September 9, 2019
• Study Completion: November 30, 2019
• Last Updated: August 22, 2025
• Results First Posted: September 7, 2020

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)