AzTrials
AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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
Show all 9Show fewer
  • 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
  • Ain Shams University Hospital

    Cairo

    Rehab F Abdelfattah Abdelrazik, 00201110108610, rehab.fattah2002@gmail.com

    Recruiting

Other trials in Egypt

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 .

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 groups in NCT05235256
Study groupRoleWhat they receive
SPGB GroupActive comparatorpatients 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 GroupActive comparatorpatients 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.

  1. 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)
  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.

  1. First posted11 Feb 2022
  2. Study start10 Jan 2022
  3. Primary completion15 Nov 2022 (estimated)
  4. Study completion1 Dec 2022 (estimated)

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in