Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Post Dural Puncture Headache (PDPH)
Primary Purpose
Headache
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sphenopalatine block
Greater occipital nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Headache
Eligibility Criteria
Inclusion Criteria:
ASA I-II Patients undergoing elective cesarean section requiring spinal anesthesia, who developed PDPH during hospitalization or within days of the intrathecal block.
Exclusion Criteria:
- Patient refusal.
- Any contraindication to regional block (coagulopathy or anticoagulant therapy).
- Local scalp infection.
- Nasal polyp, trauma, septal deviation or any nasal pathology.
- Allergy to local anesthetics.
- Pregnancy induced hypertension.
- History of major psychiatric disorders.
- Chronic headache.
- Substance abuse.
- Current opioid use.
Sites / Locations
- Assiut University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sphenopalatine block
Greater occipital nerve block
Arm Description
patients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril).
patients will receive bilateral greater occipital nerve block using a mixture of 3ml of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each side of the occipital region).
Outcomes
Primary Outcome Measures
Numeric rating pain score
pain score
Secondary Outcome Measures
Numeric rating pain score for headache.
pain score
Analgesic consumption
The total dose of analgesics.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03156049
Brief Title
Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Post Dural Puncture Headache
Acronym
PDPH
Official Title
Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Postduarl Puncture Headache
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 14, 2017 (Actual)
Primary Completion Date
June 21, 2019 (Actual)
Study Completion Date
June 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Postdural puncture headache (PDPH) is a common complication associated with neuraxial anesthesia and diagnostic lumbar puncture (LP). PDPH is defined as a bilateral headache that develops within 7 days and disappears within 14 days after the dural puncture with a distinct postural quality. PDPH causes significant short-term disability, prevents ambulation and care of the newborn (in obstetrics), and results in a prolonged hospital stay.
Detailed Description
The sphenopalatine ganglion (SPG) is an extra-cranial neural structure located in the pterygopalatine fossa that has both sympathetic and parasympathetic components as well as somatic sensory roots. The trans-nasal approach is a low risk, noninvasive technique that is easily performed and could potentially be beneficial in the treatment of PDPH through blocking the parasympathetic flow to the cerebral vasculature through the sphenopalatine ganglion which will allow the cerebral vessels to return to normal diameter and thus relieve the headache.
The greater occipital nerve contains sensory fibers from C2 and C3 segments of medulla spinals. It arises from the dorsal ramus of C2 segment, contains a thin branch from C3 segment, and innerves the medial aspect of posterior scalp up to the anterior aspect of vertex. Greater occipital nerve block (GONB) inhibits the pain sensation of this region.
There is some evidence to suggest the effectiveness of GONB in the management of PDPH. Nowadays, guidelines for the management of PDPH were modified and included GONB as a part of standard management of PDPH.
Dexamethasone possess potent antiinflammatory and immunosuppressive actions by inhibiting cytokine-mediated pathways.
Many providers believe that the local anesthetic produces the rapid onset of headache relief, like an abortive agent, and that the locally acting steroid produces the preventive like action of up to 6 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sphenopalatine block
Arm Type
Active Comparator
Arm Description
patients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril).
Arm Title
Greater occipital nerve block
Arm Type
Active Comparator
Arm Description
patients will receive bilateral greater occipital nerve block using a mixture of 3ml of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each side of the occipital region).
Intervention Type
Procedure
Intervention Name(s)
Sphenopalatine block
Other Intervention Name(s)
SPGB
Intervention Description
patients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril).
Intervention Type
Procedure
Intervention Name(s)
Greater occipital nerve block
Other Intervention Name(s)
GONB
Intervention Description
patients will receive bilateral greater occipital nerve block using a mixture of 3ml of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each side of the occipital region).
Primary Outcome Measure Information:
Title
Numeric rating pain score
Description
pain score
Time Frame
from intervention up to 24 hours
Secondary Outcome Measure Information:
Title
Numeric rating pain score for headache.
Description
pain score
Time Frame
from intervention up to 24 hours
Title
Analgesic consumption
Description
The total dose of analgesics.
Time Frame
from intervention up to 24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II Patients undergoing elective cesarean section requiring spinal anesthesia, who developed PDPH during hospitalization or within days of the intrathecal block.
Exclusion Criteria:
Patient refusal.
Any contraindication to regional block (coagulopathy or anticoagulant therapy).
Local scalp infection.
Nasal polyp, trauma, septal deviation or any nasal pathology.
Allergy to local anesthetics.
Pregnancy induced hypertension.
History of major psychiatric disorders.
Chronic headache.
Substance abuse.
Current opioid use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala Abdel-Ghaffar, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
State/Province
Assiut Governorate
ZIP/Postal Code
715715
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sphenopalatine Ganglion Block Versus Occiptal Nerve Block in Treatment of Post Dural Puncture Headache
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