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Local Anesthetic
RCT of SPG Blocks for Post-dural 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
Be between 18 and 65 years old
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
All Individual Drugs Already Approved
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
Timeline
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Epidural Blood Patch
Secondary study objectives
Verbal Functionality Score
Pain
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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?
Mayo ClinicOTHER
3,362 Previous Clinical Trials
3,066,006 Total Patients Enrolled
1 Trials studying Post-Dural Puncture Headache
18 Patients Enrolled for Post-Dural Puncture Headache
University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,120 Total Patients Enrolled
Duke UniversityOTHER
2,463 Previous Clinical Trials
2,981,905 Total Patients Enrolled
University of Colorado, DenverOTHER
1,810 Previous Clinical Trials
2,920,100 Total Patients Enrolled
1 Trials studying Post-Dural Puncture Headache
4 Patients Enrolled for Post-Dural Puncture Headache
University of California, San FranciscoOTHER
2,593 Previous Clinical Trials
14,887,950 Total Patients Enrolled
Harvard UniversityOTHER
233 Previous Clinical Trials
473,931 Total Patients Enrolled