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Clinical Trials/NCT01307839
NCT01307839
Withdrawn
Not Applicable

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

Loma Linda University1 site in 1 countryDecember 2011

Overview

Phase
Not Applicable
Intervention
5% lidocaine patch
Conditions
Pregnant
Sponsor
Loma Linda University
Locations
1
Primary Endpoint
To determine if the 5% lidocaine patch can decrease the pain from epidural placement.
Status
Withdrawn
Last Updated
14 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
April 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Richard Applegate

MD

Loma Linda University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

5% lidocaine patch

If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.

Intervention: 5% lidocaine patch

placebo patch

If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.

Intervention: placebo patch

Outcomes

Primary Outcomes

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

Study Sites (1)

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