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

Labor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01307839
• Other study ID #: 5110014
• Status: Withdrawn
• Phase: N/A
• First received: March 1, 2011
• Last updated: April 11, 2012
• Start date: December 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor
• Pregnant

Intervention

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 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

Locations

Country	Name	City	State
United States	Loma Linda University	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No