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Post-Dural Puncture HeadacheTNSPGB /GALONBNCT06705244

Trans-nasal Sphenopalatine Ganglion Block Versus Ultrasound-guided Bilateral Greater and Lesser Occipital Nerve Block for Management of Post-Dural Puncture Headache.

A study testing Trans-nasal sphenopalatine nerve block and Greater and lesser occipital nerve block 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

Post-Dural Puncture Headache (PDPH) is a complication associated with spinal anesthesia. While conventional treatments are available, the Epidural Blood Patch (EBP) is considered the gold standard. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Post-Dural Puncture Headache
What is being tested?
Trans-nasal sphenopalatine nerve block and Greater and lesser occipital nerve block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
6 Mar 2023to Dec 2024
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 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Physical status: ASA 1 or 2 and candidates for spinal anesthesia undergoing elective lower abdominal surgeries.
  • Age group: 18-45 years. Sex: Both sexes Body mass index of less than 35 kg/m2

Who cannot join

  • Declining to give written informed consent. History of allergy to the medications used in the study. Contraindications to regional anesthesia (including coagulopathy, and local infection).
  • Psychiatric disorder and/or Drug Addiction. American Society of Anesthesiologists (ASA) Physical Status Class III and more. Moderate to severe hepatic and renal diseases. Emergency surgeries. Nasal septal deviation, Nasal deformity and/or nasal bleeding. Had received opioids less than 12 hours before study inclusion. History of migraines or persistent headaches.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ain Shams University Hospitals

    Cairo, Abbasia

Other trials in Egypt

About this study

Official title: Trans-nasal Sphenopalatine Ganglion Block Versus Ultrasound-guided Bilateral Greater and Lesser Occipital Nerve Block for Management of Post-Dural Puncture Headache After Spinal Anesthesia in Patients Undergoing Lower Abdominal Surgeries

Post-Dural Puncture Headache (PDPH) is a complication associated with spinal anesthesia. While conventional treatments are available, the Epidural Blood Patch (EBP) is considered the gold standard. Other less invasive interventions, such as Sphenopalatine Ganglion (SPG) block and Greater Occipital Nerve (GON) block, have also been used to treat PDPH. The trans-nasal approach is a non-invasive, low-risk technique that can be performed at the bedside without imaging tools.

The Lesser Occipital Nerve Block (LONB) is often used in conjunction with the GONB to address headaches in the lateral occipital region.

Read more

This study aims to compare the efficacy of trans-nasal sphenopalatine ganglion block (TNSGB) versus Greater and Lesser Occipital Nerve Block (GALONB) guided by ultrasound in relieving PDPH and its symptoms, as well as to assess patient satisfaction with the interventions.

Conducted at Ain Shams University Hospitals with approval from the medical ethical committee, the study included 50 participants (25 per group) who were ASA class I or II candidates for spinal anesthesia undergoing elective lower abdominal surgeries. Participants were randomly assigned to two groups:

  • Group TNSGB: Received a trans-nasal sphenopalatine ganglion block using cotton-tipped applicators inserted trans-nasally until positioned in the posterior nasopharynx.
  • Group GALONB: Received a Greater and Lesser Occipital Nerve Block under ultrasound guidance to identify nerves, foramina, vascular structures, and their course.

Patient satisfaction was evaluated using a 5-point Likert scale. The analgesic efficacy of TNSGB versus GALONB was assessed using a Numeric Rating Scale (NRS) at 0, 30 minutes, 1, 2, 3, 6, 12, 24, and 48 hours after treatment.

Adverse events, the need for rescue analgesia, and other therapeutic interventions were also recorded.

Read the detailed description
  • Type of Study:

Exploratory single-blind randomized comparative trial. (Only the data collection personnel were blinded to the group assignment).

  • Study Settings: Ain Shams University Hospitals.
  • Study Period: 6 months
  • Study Population:

All patients included in this study met the International Headache Society criteria for diagnosis of PDPH, as follows:

  1. headache that:
  2. worsens within 15 minutes of sitting or standing; b) improves within 15 minutes after lying down; c) must have one of the following associated manifestations of: neck stiffness, tinnitus, hypoacusis, or photophobia;
  3. dural puncture has been performed;
  4. headache develops within 5 days after dural puncture. The headache should have persisted for at least two days and must have been intractable to conservative treatment with fluids, caffeine, paracetamol, and other nonopioid analgesics. Failure of conservative management was defined as headache score \> 4/10 on a numerical rating scale (NRS) when the patient assumed an upright position. -Inclusion Criteria: Physical status: ASA 1 or 2 and candidates for spinal anesthesia undergoing elective lower abdominal surgeries. Age group: 18-45 years. Sex: Both sexes Body mass index of less than 35 kg/m2 -Exclusion Criteria: Declining to give written informed consent. History of allergy to the medications used in the study. Contraindications to regional anesthesia (including coagulopathy, and local infection). Psychiatric disorder and/or Drug Addiction. American Society of Anesthesiologists (ASA) Physical Status Class III and more. Moderate to severe hepatic and renal diseases. Emergency surgeries. Nasal septal deviation, Nasal deformity and/or nasal bleeding. Had received opioids less than 12 hours before study inclusion. History of migraines or persistent headaches. •Sampling Method: Patients fulfilling inclusion criteria will be randomly divided into two groups using their computer-generated random numbers. •Sampling Size: An exploratory study will be conducted that includes at least 50 participants (25/group) to compare the efficacy of trans-nasal sphenopalatine ganglion block (TNSGB) and greater and lesser occipital nerve block (GALONB) to relieve PDPH and its associated symptoms. •Ethical Considerations: The study will be performed after ethical committee approval and informed consent from the patients after full explanation of the procedure, possible side effects and complications. Informed written consent was taken from all patients after explaining the study procedure in detail.
  • Study Procedure:
  • Pre-operative Settings: All patients will have the same preoperative preparation and anesthetic technique. History and general examination will be done to all patients and routine investigations will be done preoperatively as laboratory investigations (complete blood picture, bleeding time, INR, partial thromboplastin-time, and blood chemistry as liver and kidney function tests). Age, weight, and sex will be recorded.
  • Intra-operative Settings: Inside the operating room/ward, intravenous access will be inserted, monitor connected and baseline non-invasive blood pressure (NBP), heart rate (HR), electrocardiography (ECG) and oxygen saturation (SpO2) will be measured. Patients were randomly allocated into 2 groups.
  • TNSPGB Group: The patient was placed supine with shoulders slightly elevated to flex the neck and extend the head. Then anterior nares were inspected for polyps, tumors, or significant septal deviation. Long cotton-tipped applicators saturated with lidocaine 2% were inserted into each naris, until properly seated in the posterior nasopharynx. These were left in place for 10 minutes to lubricate and anesthetize the mucous membrane, making the procedure more comfortable. Then a mixture of 3 mL of 2 mL lidocaine 2% plus 1 mL dexamethasone 4 mg were injected through the applicators in the sphenopalatine area in each nostril. (Youssef et al., 2021) Then the patient was positioned sitting and pain assessments were recorded. o GALONB Group: The back of the head was sterilized with an antiseptic solution and the landmarks at the base of the skull were identified while the patient in the prone position. The landmarks were located on the medial third of a line drawn from occipital protuberance to mastoid process. At this level, the greater and lesser occipital nerves lie along the superior nuchal line medial to the occipital artery, halfway between the occipital protuberance and mastoid process. Under Ultrasound guidance, the skin was infiltrated with 1-2 mL of lidocaine 2%, using a 25-gauge needle. Then the block was performed in this area with a mixture of 3 mL of 2 mL lidocaine 2% plus 1 mL dexamethasone 4 mg to block greater and lesser occipital nerves. Then the procedure was repeated on the other side. After the procedure, the presence of bilateral occipital numbness was confirmed after 30 minutes. The patient was then positioned sitting and pain scoring was assessed. *Both blocks will be done and/or supervised by an expert all through.
Being tested
Trans-nasal sphenopalatine nerve block, Greater and lesser occipital nerve block
Keywords
Post dural Puncture headache, Trans-nasal Sphenopalatine Ganglion Block, Greater Occipital Nerve block, Lesser Occipital Nerve block, Spinal Anesthesia, Pain management, Ultrasound guided nerve blocks
Medical subject headings
Post-Dural Puncture Headache, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trans-nasal sphenopalatine nerve blockProcedure or surgery

    The patient was placed supine with shoulders slightly elevated to flex the neck and extend the head.

    Then anterior nares were inspected for polyps, tumors, or significant septal deviation.

    Long cotton-tipped applicators saturated with lidocaine 2% were inserted into each naris, until properly seated in the posterior nasopharynx.

    These were left in place for 10 minutes to lubricate and anesthetize the mucous membrane, making the procedure more comfortable.

    Then a mixture of 3 mL of 2 mL lidocaine 2% plus 1 mL dexamethasone 4 mg were injected through the applicators in the sphenopalatine area in each nostril.

    Then the patient was positioned sitting and pain assessments were recorded.

  • Greater and lesser occipital nerve blockProcedure or surgery

    The back of the head was sterilized with an antiseptic solution and the landmarks at the base of the skull were identified while the patient in the prone position.

    The landmarks were located on the medial third of a line drawn from occipital protuberance to mastoid process. At this level, the greater and lesser occipital nerves lie along the superior nuchal line medial to the occipital artery, halfway between the occipital protuberance and mastoid process.

    Under Ultrasound guidance, the skin was infiltrated with 1-2 mL of lidocaine 2%, using a 25-gauge needle. Then the block was performed in this area with a mixture of 3 mL of 2 mL lidocaine 2% plus 1 mL dexamethasone 4 mg to block greater and lesser occipital nerves. Then the procedure was repeated on the other side.

    After the procedure, the presence of bilateral occipital numbness was confirmed after 30 minutes. The patient was then positioned sitting and pain scoring was assessed.

Study groups in NCT06705244
Study groupRoleWhat they receive
trans-nasal sphenopalatine ganglion block (TNSGB)Active comparatorNot described
Receives: Procedure: Trans-nasal sphenopalatine nerve block
greater and lesser occipital nerve block (GALONB)Active comparatorNot described
Receives: Procedure: Greater and lesser occipital nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient satisfaction

    Patients were asked to evaluate their satisfaction regarding the received intervention through 5-point Likert scale (1 = very satisfied, 2 = satisfied, 3 = neither satisfied nor dissatisfied, 4 = dissatisfied, 5= very dissatisfied).

    Measured: After 48 hours

Secondary outcomes (2)
  1. the analgesic efficacy of the TNSPGB versus GALONB for treatment of PDPH

    using a Numeric Rating Scale (NRS) from 0 to 10

    Measured: at baseline 0, at 30 minutes, 1 hour , 2 hours, 3 hours, 6 hours, 12 hours, 24hours and 48 hours after treatment.

  2. Need for rescue analgesia

    Need for rescue analgesia If pain score on Numeric rating scale = or > 4

    Measured: after 4 hours of given intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start6 Mar 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (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
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06705244
Sponsor's protocol ID
FMASU MS141/2024
Acronym
TNSPGB /GALONB
Status last verified
Feb 2024
First submitted
10 Sep 2024
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Uyar Turkyilmaz E, Camgoz Eryilmaz N, Aydin Guzey N, Moraloglu O. Bilateral greater occipital nerve block for treatment of post-dural puncture headache after caesarean operations. Braz J Anesthesiol. 2016 Sep-Oct;66(5):445-50. doi: 10.1016/j.bjane.2015.03.004. Epub 2016 Jan 21.

    PubMed 27591456
  • Goncalves LM, Godinho PM, Duran FJ, Valente EC. Sphenopalatine ganglion block by transnasal approach in post-dural puncture headache. J Clin Anesth. 2018 Aug;48:50. doi: 10.1016/j.jclinane.2018.05.006. Epub 2018 May 8. No abstract available.

    PubMed 29751211
  • Nair AS, Kodisharapu PK, Anne P, Saifuddin MS, Asiel C, Rayani BK. Efficacy of bilateral greater occipital nerve block in postdural puncture headache: a narrative review. Korean J Pain. 2018 Apr;31(2):80-86. doi: 10.3344/kjp.2018.31.2.80. Epub 2018 Apr 2.

    PubMed 29686805
  • Youssef HA, Abdel-Ghaffar HS, Mostafa MF, Abbas YH, Mahmoud AO, Herdan RA. Sphenopalatine Ganglion versus Greater Occipital Nerve Blocks in Treating Post-Dural Puncture Headache after Spinal Anesthesia for Cesarean Section: A Randomized Clinical Trial. Pain Physician. 2021 Jul;24(4):E443-E451.

    PubMed 34213869

Questions about this trial

What is this clinical trial studying?

A study testing Trans-nasal sphenopalatine nerve block and Greater and lesser occipital nerve block 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 2 inclusion and 2 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 26 Nov 2024. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient satisfaction (time frame: After 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06705244, which also lists 4 linked publications.

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 26 Nov 2024.

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