Lidocaine Patch for Relief of Pain During Epidural Placement in Laboring Patients

April 11, 2012 updated by: Richard Applegate, Loma Linda University

A Randomized, Controlled Trial of the Lidocaine Patch for Relief of Pain During Epidural Needle Insertion in Laboring Patients

Infiltration of the skin with lidocaine is standard practice prior to lumbar epidural placement in laboring parturients1. Skin infiltration, although brief, can be very stressful and painful for patients.2 This initial discomfort may cause patient anxiety, thus increasing the pain and decreasing the satisfaction with the procedure. To reduce this discomfort, various topical alternatives have been investigated with varying degrees of success.1-4 Now that a topical mixture of lidocaine that is safe and effective is available, the investigators would like to determine if it can reduce the pain of skin infiltration in particular and epidural placement as a whole.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

1. Laboring patients between the ages of 18 and 45 with a BMI of less than 45

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 5% lidocaine patch
If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.
Drug: 5% lidocaine patch
Research intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours.
Placebo Comparator: placebo patch
If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.
Drug: placebo patch
Research intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine if the 5% lidocaine patch can decrease the pain from epidural placement.
Time Frame: a minimum of 30 minutes from patch placement and a maximum of 12 hours
a minimum of 30 minutes from patch placement and a maximum of 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Richard L Applegate, MD, Loma Linda University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

April 1, 2012

Study Registration Dates

First Submitted

March 1, 2011

First Submitted That Met QC Criteria

March 2, 2011

First Posted (Estimate)

March 3, 2011

Study Record Updates

Last Update Posted (Estimate)

April 12, 2012

Last Update Submitted That Met QC Criteria

April 11, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5110014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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