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

Not Applicable

Withdrawn

• Conditions: Pregnant; Labor
• Interventions: Drug: placebo patch; Drug: 5% lidocaine patch

• Registration Number: NCT01307839
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-03
• Study Start: 2011-12
• Status Verified: 2012-04
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-11
• Last Update Posted: 2012-04-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo patch	placebo patch	If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.
5% lidocaine patch	5% lidocaine patch	If the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Loma Linda University; 🇺🇸 Loma Linda, California, United States