Sphenopalatine Block Versus Greater Occipital Nerve Block in PDPH
Primary Purpose
Post-Dural Puncture Headache
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
bilateral sphenopalatine ganglion block
bilateral greater occipital nerve block
lidocaine plus dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Post-Dural Puncture Headache
Eligibility Criteria
Inclusion Criteria:
- Obstetric patients ( American Society of Anesthesiologists ) ASA I&II ,body weight between 60-100kg expressing PDPH after spinal anesthesia, (VAS > 4 ) with standard treatment such as intravenous fluids, abdominal binder, bed rest and caffeine.
Exclusion Criteria:
• ASA III& IV patients.
- Refusal of the patient.
- Patients with chronic headache or migraine.
- Hypertensive patients.
- A patient that cannot comply with the VAS.
- Infection at site of the block
- Known coagulation defect.
- Nasal septal deviation, polyp, history of nasal bleeding.
- Allergy to local anaesthetics.
Sites / Locations
- Ain Shams University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SPGB Group
GONB Group
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
Visual Analogue Score (VAS )
Visual A nalogue Scale will be used to asses the efficacy of either SPGB or GONB for treatment of PDPH .Score from 0 to 100 (0=no pain, 100=most severe pain)
Secondary Outcome Measures
total analgesic consumption
total dose of ketorolac will be calculated
Full Information
NCT ID
NCT05235256
First Posted
November 16, 2021
Last Updated
November 11, 2022
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05235256
Brief Title
Sphenopalatine Block Versus Greater Occipital Nerve Block in PDPH
Official Title
Lecturer of Anesthesia- Anesthesia Department Ain Shams University
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams 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
5. Study Description
Brief Summary
Management of postdural puncture headache (PDPH) has always been challenging for anesthesiologists. PDPH not only increases the misery of the patient, but the length of stay and overall cost of treatment in the hospital also increases. Although the epidural blood patch ( EBP ) is an effective way of treating the problem, the procedure itself could cause another inadvertent dural puncture (DP). Moreover, sometimes patients need to have a second EBP, if the first one is not completely effective. This can be difficult to explain to the patient who has already suffered a lot. Peripheral nerve blocks are well tolerated and effective as adjunctive therapy for many disabling headache disorder.
Sphenopalatine ganglion is a parasympathetic ganglion, located in the pterygopalatine fossa. Transnasal sphenopalatine ganglion block ( SPGB ) has been successfully used to treat chronic conditions such as migraine, cluster headache, and trigeminal neuralgia, and may be a safer alternative to treat PDPH: It is minimally invasive and carried out at the bedside without using imaging. Besides that, it has apparently a faster start than EBP, with better safety profile.
Another minimally invasive peripheral nerve block which has been used quite successful is greater occipital nerve block (GONB). The GONB has been in use for more than a decade to treat complex headache syndromes of varying etiologies like migraine , cluster headache and chronic daily headache with encouraging results. Greater Occipital Nerve (GON) arises from C2-3 segments, its most proximal part lies between obliqua capitis inferior and semispinalis, near the spinous process. Then, GON enters into semispinalis passing through it and after its exit; it enters into trapezius muscle. In distal region of trapezius fascia, it is crossed by the occipital artery and finally the nerve exits the trapezius fascia insertion into the nuchal line about 5-cm lateral to midline. Functionally, GON supplies major rectus capitis posterior muscle, and the skin, muscles, and vessels of the scalp, but is the main sensory supply of occipital region.
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 as dexamethasone possess potent anti inflammatory and immunosuppressive actions by inhibiting cytokine-mediated pathways .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SPGB Group
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
GONB Group
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)
bilateral sphenopalatine ganglion block
Intervention Description
peripheral n block
Intervention Type
Procedure
Intervention Name(s)
bilateral greater occipital nerve block
Intervention Description
bilateral greater occipital nerve block
Intervention Type
Drug
Intervention Name(s)
lidocaine plus dexamethasone
Intervention Description
lidocaine plus dexamethasone
Primary Outcome Measure Information:
Title
Visual Analogue Score (VAS )
Description
Visual A nalogue Scale will be used to asses the efficacy of either SPGB or GONB for treatment of PDPH .Score from 0 to 100 (0=no pain, 100=most severe pain)
Time Frame
first 24 hours after the procedure
Secondary Outcome Measure Information:
Title
total analgesic consumption
Description
total dose of ketorolac will be calculated
Time Frame
first 24 hours after the block
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obstetric patients ( American Society of Anesthesiologists ) ASA I&II ,body weight between 60-100kg expressing PDPH after spinal anesthesia, (VAS > 4 ) with standard treatment such as intravenous fluids, abdominal binder, bed rest and caffeine.
Exclusion Criteria:
• ASA III& IV patients.
Refusal of the patient.
Patients with chronic headache or migraine.
Hypertensive patients.
A patient that cannot comply with the VAS.
Infection at site of the block
Known coagulation defect.
Nasal septal deviation, polyp, history of nasal bleeding.
Allergy to local anaesthetics.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
lecturer of anesthesia
Phone
01110108610
Ext
002
Email
rehab.fattah2002@gmail.com
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab F Abdelfattah Abdelrazik
Phone
00201110108610
Email
rehab.fattah2002@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Sphenopalatine Block Versus Greater Occipital Nerve Block in PDPH
We'll reach out to this number within 24 hrs