Post-Dural Puncture HeadacheNCT05235256
Sphenopalatine Block Versus Greater Occipital Nerve Block in PDPH
A study testing bilateral sphenopalatine ganglion block, bilateral greater occipital nerve block and lidocaine plus dexamethasone in people with Post-Dural Puncture Headache, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- bilateral sphenopalatine ganglion block, bilateral greater occipital nerve block and lidocaine plus dexamethasone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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
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- Known coagulation defect.
- Nasal septal deviation, polyp, history of nasal bleeding.
- Allergy to local anaesthetics.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospital
Cairo
Rehab F Abdelfattah Abdelrazik, 00201110108610, rehab.fattah2002@gmail.com
About this study
Official title: Lecturer of Anesthesia- Anesthesia Department Ain Shams University
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.
Read more
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 .
- Conditions
- Post-Dural Puncture Headache
- Being tested
- bilateral sphenopalatine ganglion block, bilateral greater occipital nerve block, lidocaine plus dexamethasone
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral sphenopalatine ganglion blockProcedure or surgery
peripheral n block
bilateral greater occipital nerve blockProcedure or surgery
bilateral greater occipital nerve block
lidocaine plus dexamethasoneDrug
lidocaine plus dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| SPGB Group | Active comparator | patients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril). Receives: Procedure: bilateral sphenopalatine ganglion block; Drug: lidocaine plus dexamethasone |
| GONB Group | Active comparator | 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). Receives: Procedure: bilateral greater occipital nerve block; Drug: lidocaine plus dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: first 24 hours after the procedure
Secondary outcomes (1)
total analgesic consumption
total dose of ketorolac will be calculated
Measured: first 24 hours after the block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start10 Jan 2022
- Primary completion15 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235256
- Sponsor's protocol ID
- FMASU R 80/2021
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2021
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer of Anesthesia- Anesthesia Department Ain Shams University
- ClinicalTrials.gov ID
- NCT05235256
- Acronym / sponsor ID
- FMASU R 80/2021
- Conditions
- Post-Dural Puncture Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPGB Group | Active comparator | Procedure: bilateral sphenopalatine ganglion block, Drug: lidocaine plus dexamethasonepatients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril). |
| GONB Group | Active comparator | Procedure: bilateral greater occipital nerve block, Drug: lidocaine plus dexamethasonepatients 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). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- • ASA III\& IV patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral sphenopalatine ganglion blockperipheral n block | Procedure or surgery | SPGB Group |
| bilateral greater occipital nerve blockbilateral greater occipital nerve block | Procedure or surgery | GONB Group |
| lidocaine plus dexamethasonelidocaine plus dexamethasone | Drug | GONB Group, SPGB Group |
Primary outcome
Visual Analogue Score (VAS )
Time frame: first 24 hours after the procedure
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)
1 secondary outcome
total analgesic consumption
Time frame: first 24 hours after the block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral sphenopalatine ganglion block, bilateral greater occipital nerve block and lidocaine plus dexamethasone in people with Post-Dural Puncture Headache, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact lecturer of anesthesia (01110108610 ext. 002, rehab.fattah2002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (VAS ) (time frame: first 24 hours after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.