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Local Anesthetic
Lidocaine for Post-Dural Puncture Headache
Phase 2
Waitlist Available
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females
age 18-50
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day, 2, days, 3 days, 4 days, 5 days, 6 days, and 7 days after treatment with lidocaine or placebo block
Awards & highlights
Study Summary
The purpose of the study is to assess the effectiveness of the SPG block with lidocaine vs. SPG block with placebo on preventing the need for EBP in women who develop PDPH after accidental dural puncture during placement of LEA for labor.
Eligible Conditions
- Post-Dural Puncture Headache
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days after treatment with lidocaine or placebo block
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after treatment with lidocaine or placebo block
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Epidural Blood Patch
Secondary outcome measures
Verbal Functionality Score
Pain
Side effects data
From 2014 Phase 4 trial • 40 Patients • NCT0160269240%
Nausea
10%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tumescent Solution With Dilute Epinephrine
Tumescent Solution With Dilute Lidocaine and Epinephrine
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LidocaineExperimental Treatment1 Intervention
Transnasal blockade of SPG approach involving the application of 2 cc (approximately the size of a pea) of 2% lidocaine jelly on a cotton swab directed posteriorly towards the SPG in the nasal passage bilaterally. Cotton swab will be inserted to the back of the nasal passage until it can no longer be inserted any further. The cotton swab should remain in place for 15 minutes on both sides simultaneously. The patient will be instructed on how to perform this procedure on themselves, and they will be given supplies for a 7-day supply of medication to be administered two times per day at approximately 12 hour intervals.
Group II: PlaceboPlacebo Group1 Intervention
Transnasal blockade of SPG approach involving the application of 2 cc (approximately the size of a pea) of nasal saline jelly on a cotton swab directed posteriorly towards the SPG in the nasal passage bilaterally. Cotton swab will be inserted to the back of the nasal passage until it can no longer be inserted any further. The cotton swab should remain in place for 15 minutes. The patient will be instructed on how to perform this procedure on themselves, and they will be given supplies for a 7-day supply of medication to be administered up to two times per day at approximately 12 hour intervals.
Find a Location
Who is running the clinical trial?
University of UtahLead Sponsor
1,088 Previous Clinical Trials
1,728,349 Total Patients Enrolled
University of Colorado, DenverOTHER
1,726 Previous Clinical Trials
2,141,676 Total Patients Enrolled
1 Trials studying Post-Dural Puncture Headache
4 Patients Enrolled for Post-Dural Puncture Headache
University of California, San FranciscoOTHER
2,493 Previous Clinical Trials
11,931,798 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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