Study Stopped
Study was stopped due to non-availability of the lidocaine placebo patches.
Lidocaine Patch for Relief of Pain During Epidural Placement in Laboring Patients
A Randomized, Controlled Trial of the Lidocaine Patch for Relief of Pain During Epidural Needle Insertion in Laboring Patients
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2011
CompletedFirst Posted
Study publicly available on registry
March 3, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedApril 12, 2012
April 1, 2012
4 months
March 1, 2011
April 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
5% lidocaine patch
ACTIVE COMPARATORIf the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.
placebo patch
PLACEBO COMPARATORIf the patient chooses to participate, the resident will place the patch over the lower lumbar area of the back.
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- \. Laboring patients between the ages of 18 and 45 with a BMI of less than 45
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loma Linda University
Loma Linda, California, 92354, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Richard L Applegate, MD
Loma Linda University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 1, 2011
First Posted
March 3, 2011
Study Start
December 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
April 12, 2012
Record last verified: 2012-04