Post-Dural Puncture HeadacheNCT04844229
Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache
A study testing Bilateral transnasal sphenopalatine ganglion block. and Bilateral ultrasound guided greater occipital nerve block. in people with Post-Dural Puncture Headache, run by Zagazig University at 1 site in Egypt.
Trial summary
Post-dural puncture headache is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Bilateral transnasal sphenopalatine ganglion block. and Bilateral ultrasound guided greater occipital nerve block.
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jun 2021to 30 Jun 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient acceptance.
- Age 21- 40 years old.
- Post-partum females suffering PDPH with visual analogue score (VAS) ≥ 4 and modified Lybecker classification score ≥ 2
- ASA II (due to pregnancy).
- Body mass index < 35Kg/m2
- Accepted mental state of the patient.
Who cannot join
- Emergent cesarean section.
- Hypertensive disorders of the pregnancy.
- History of allergy to local anesthetics.
- History of chronic headache, migraine, convulsions, and cerebrovascular accident.
- Contraindication to spinal anesthesia: coagulopathy, infection at site of injection.
- Inadequate temporal window
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache After Spinal Anesthesia
Post-dural puncture headache is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia. Conservative treatment for PDPH includes adequate hydration, systemic analgesia with paracetamol and non-steroidal anti-inflammatory drugs and increased caffeine intake, as well as bed rest. If these measures are unsuccessful, the gold standard for the treatment of PDPH is the epidural blood patch which is an invasive technique.
The use of nerve blocks for treating headache symptoms are well known techniques that have been previously used for managing some specific types of chronic headache such as cervicogenic headache, cluster headache, migraine, and occipital neuralgia and there are some recently published studies reporting that these blocks may be beneficial in treating PDPH and the available evidence although showing improvements in the visual analogue (VAS) scores and a reduced number of patients requiring an epidural blood patch, but it is still poor.
Less invasive techniques such as SPG block and GONB are attractive therapeutic options which may eliminate the need for EBP in obstetric patients suffering from PDPH. Up to the best of our knowledge this is the first randomized trial to investigate the analgesic efficacy of adding SPG block either alone or in combination with GONB to PDPH treatment.
Read the detailed description
Post-dural puncture headache (PDPH) is a relatively common complication following dural puncture which is more frequently noted in parturients undergoing cesarean section (CS) under neuraxial anesthesia. The mechanism of nociception in PDPH is still indistinct. However, it is thought to be related to the decrease in intracranial pressure caused by the cerebrospinal fluid (CSF) leak through the dural defect leading to a downward pull of intracranial nociceptive structures which is further exacerbated by compensatory cerebral vasodilation. Managing Post-dural Puncture Headache is a challenge for most anesthesiologists as the gold standard and definitive treatment; epidural blood patch (EBP) itself can lead to inadvertent dural puncture that caused the complication in the first place. Medical and conservative management of PDPH may not provide symptomatic relief and anesthesiologists are on a constant lookout for techniques that can provide immediate and sustained relief from this debilitating complication.
The use of regional techniques and nerve blocks for the treatment of headache symptoms are well known techniques. The transnasal sphenopalatine ganglion (SPG) block which is an easy block that requires minimal training was shown to be helpful in the PDPH treatment with promising results. The SPG surrounded by mucous membrane within the posterior nasal turbinate, is a parasympathetic ganglion of cranial nerve (CN) VII which mediates intracranial vasodilation. The role of this block in PDPH management may be due to the vasoconstriction resulting from the parasympathetic block. Additionally, its relationship to the fifth cranial nerve (trigeminal nerve) may simultaneously relieve the frontal headache.
Another regional technique that can be used is the Greater Occipital Nerve Block (GONB) that has been previously used for managing some specific types of chronic headache such as cervicogenic headache, cluster headache, migraine, and occipital neuralgia and there are some recently published studies reporting that GONB may have a beneficial role in PDPH management. In addition, it is a superficial block which can be done at the patient's bedside under ultrasound guidance. The greater occipital nerve is the main sensory nerve of the occipital region that arises from the dorsal ramus of cervical spinal nerve II. The neuromodulation effect together with decreased central sensitivity resulting from meningial and paraspinal muscles irritation as well as blocking the spinal cord dorsal horn afferent fibers may explain the role of GONB in relieving PDPH symptoms. Moreover, the sensitive neurons of the upper cervical cord are close to the trigeminal caudal nucleus. Therefore, its afferences may also be blocked with this technique.
The available evidence of these blocks for treating PDPH although showing improvements in the visual analogue (VAS) scores and a reduced number of patients requiring an epidural blood patch, but it is still poor. Moreover, there are some clinical scenarios in which the patient may refuse treatment with the epidural blood patch, or there may be a contraindication for its use. Hence, we hypothesized those obstetric patients who are particularly prone to PDPH may get benefit from these less invasive techniques and that these blocks may be added to the treatment of patients suffering from PDPH in order to avoid the invasive EBP.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Bilateral transnasal sphenopalatine ganglion block., Bilateral ultrasound guided greater occipital nerve block.
- 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 transnasal sphenopalatine ganglion block.Procedure or surgery
Also called (SPG) block.
SPG block will be performed with the patient in supine position using cotton-tipped plastic hollow applicator inserted in the nose with the swab soaked in 1.5 ml 10%lignocaine. The applicator will be inserted parallel to the floor of the nose until resistance encountered. The swab will be rested in the pterygopalatine fossa superior to the middle turbinate and removed after 10 min. This procedure will be repeated in the other nostril too.
Bilateral ultrasound guided greater occipital nerve block.Procedure or surgery
Also called (GONB).
GONB will be performed with the patients lying in prone position using high frequency (6-13 MHz) probe of Siemens Acuson X300 machine placed in transverse orientation lateral to external occipital protuberance parallel to the superior nuchal line to detect occipital artery where the nerve is located medial to it 1.5inch; then 20 gauge needle will be inserted out of plane to avoid vascular injury. 4 ml of treatment solution containing 2.5 mg/ml bupivacaine and 1 mg/ml dexamethasone (prepared by adding 2 ml bupivacaine 0.5% + 1 ml dexamethasone + 1 ml saline) will be injected on each side.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 21 patients will receive conservative management for PDPH in the form of oral paracetamol 1000 mg/8hours, and caffeine 300-500 mg/day, 1000 mL 0.9% normal saline infusion over the initial 4 hours with increasing oral fluids and bed rest to be maintained. After 6 hour of starting treatment if the above measures failed to control pain with the VAS ≥ 4 non-steroidal anti-inflammatory drugs (NSAID) will be added in the form of ketorolac 30 mg IV which can be repeated every 12 hours if needed. Participants will be followed up after 1 hour, 6 hours and 24 hours with assessment of VAS score, modified Lybecker clas¬sification score and TCD parameters. EBP will be considered after 24 hours of treatment if pain still not controlled with VAS ≥ 4 and modified Lybecker clas¬sification score ≥ 2 and after patients' consent. |
| Interventional group | Active comparator | 21 patients will receive the same conservative management as in control group together with bilateral transnasal sphenopalatine ganglion block.
After one hour Participants who will show improvement in pain scores will be followed up after 6 hours and 24 hours, while, patients who will show persistent headache will be subjected for bilateral ultrasound guided greater occipital nerve block.
then these patients will be assessed after 1 h, 6 h, and 24 h of the block. If still suffering epidural blood patch will be indicated and performed after gaining patients' consent. Receives: Procedure: Bilateral transnasal sphenopalatine ganglion block.; Procedure: Bilateral ultrasound guided greater occipital nerve block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
pain score
Measured: 24 hours
Secondary outcomes (1)
Trans-Carnial Doppler
to measure mean flow velocity and the Gosling pulsatility index
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start20 Jun 2021
- Primary completion30 May 2022
- Study completion30 Jun 2022
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 Zagazig 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr Shaaban Elshafei, Zagazig University
- Investigators
- Sherif Mo Mowafy, MD, Study director, Assistant professor of Anesthesia & Surgical Intensive Care Faculty of Medicine - Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844229
- Sponsor's protocol ID
- 6868
- Status last verified
- Oct 2022
- First submitted
- 10 Apr 2021
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Sphenopalatine Ganglion Block With or Without Bilateral Greater Occipital Nerve Block for Treatment of Obstetric Post-Dural Puncture Headache After Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04844229
- Acronym / sponsor ID
- 6868
- Conditions
- Post-Dural Puncture Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Jun 2021 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Apr 2021 (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.
Post-dural puncture headache is a common complication, following neuraxial techniques. The obstetric population is particularly prone to PDPH. Therefore, treatment of PDPH is a key issue in obstetric anesthesia. Conservative treatment for PDPH includes adequate hydration, systemic analgesia with paracetamol and non-steroidal anti-inflammatory drugs and increased caffeine intake, as well as bed rest. If these measures are unsuccessful, the gold standard for the treatment of PDPH is the epidural blood patch which is an invasive technique.
The use of nerve blocks for treating headache symptoms are well known techniques that have been previously used for managing some specific types of chronic headache such as cervicogenic headache, cluster headache, migraine, and occipital neuralgia and there are some recently published studies reporting that these blocks may be beneficial in treating PDPH and the available evidence although showing improvements in the visual analogue (VAS) scores and a reduced number of patients requiring an epidural blood patch, but it is still poor.
Less invasive techniques such as SPG block and GONB are attractive therapeutic options which may eliminate the need for EBP in obstetric patients suffering from PDPH. Up to the best of our knowledge this is the first randomized trial to investigate the analgesic efficacy of adding SPG block either alone or in combination with GONB to PDPH treatment.
Detailed description
Post-dural puncture headache (PDPH) is a relatively common complication following dural puncture which is more frequently noted in parturients undergoing cesarean section (CS) under neuraxial anesthesia. The mechanism of nociception in PDPH is still indistinct. However, it is thought to be related to the decrease in intracranial pressure caused by the cerebrospinal fluid (CSF) leak through the dural defect leading to a downward pull of intracranial nociceptive structures which is further exacerbated by compensatory cerebral vasodilation. Managing Post-dural Puncture Headache is a challenge for most anesthesiologists as the gold standard and definitive treatment; epidural blood patch (EBP) itself can lead to inadvertent dural puncture that caused the complication in the first place. Medical and conservative management of PDPH may not provide symptomatic relief and anesthesiologists are on a constant lookout for techniques that can provide immediate and sustained relief from this debilitating complication.
The use of regional techniques and nerve blocks for the treatment of headache symptoms are well known techniques. The transnasal sphenopalatine ganglion (SPG) block which is an easy block that requires minimal training was shown to be helpful in the PDPH treatment with promising results. The SPG surrounded by mucous membrane within the posterior nasal turbinate, is a parasympathetic ganglion of cranial nerve (CN) VII which mediates intracranial vasodilation. The role of this block in PDPH management may be due to the vasoconstriction resulting from the parasympathetic block. Additionally, its relationship to the fifth cranial nerve (trigeminal nerve) may simultaneously relieve the frontal headache.
Another regional technique that can be used is the Greater Occipital Nerve Block (GONB) that has been previously used for managing some specific types of chronic headache such as cervicogenic headache, cluster headache, migraine, and occipital neuralgia and there are some recently published studies reporting that GONB may have a beneficial role in PDPH management. In addition, it is a superficial block which can be done at the patient's bedside under ultrasound guidance. The greater occipital nerve is the main sensory nerve of the occipital region that arises from the dorsal ramus of cervical spinal nerve II. The neuromodulation effect together with decreased central sensitivity resulting from meningial and paraspinal muscles irritation as well as blocking the spinal cord dorsal horn afferent fibers may explain the role of GONB in relieving PDPH symptoms. Moreover, the sensitive neurons of the upper cervical cord are close to the trigeminal caudal nucleus. Therefore, its afferences may also be blocked with this technique.
The available evidence of these blocks for treating PDPH although showing improvements in the visual analogue (VAS) scores and a reduced number of patients requiring an epidural blood patch, but it is still poor. Moreover, there are some clinical scenarios in which the patient may refuse treatment with the epidural blood patch, or there may be a contraindication for its use. Hence, we hypothesized those obstetric patients who are particularly prone to PDPH may get benefit from these less invasive techniques and that these blocks may be added to the treatment of patients suffering from PDPH in order to avoid the invasive EBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –21 patients will receive conservative management for PDPH in the form of oral paracetamol 1000 mg/8hours, and caffeine 300-500 mg/day, 1000 mL 0.9% normal saline infusion over the initial 4 hours with increasing oral fluids and bed rest to be maintained. After 6 hour of starting treatment if the above measures failed to control pain with the VAS ≥ 4 non-steroidal anti-inflammatory drugs (NSAID) will be added in the form of ketorolac 30 mg IV which can be repeated every 12 hours if needed. Participants will be followed up after 1 hour, 6 hours and 24 hours with assessment of VAS score, modified Lybecker clas¬sification score and TCD parameters. EBP will be considered after 24 hours of treatment if pain still not controlled with VAS ≥ 4 and modified Lybecker clas¬sification score ≥ 2 and after patients' consent. |
| Interventional group | Active comparator | Procedure: Bilateral transnasal sphenopalatine ganglion block., Procedure: Bilateral ultrasound guided greater occipital nerve block.21 patients will receive the same conservative management as in control group together with bilateral transnasal sphenopalatine ganglion block. After one hour Participants who will show improvement in pain scores will be followed up after 6 hours and 24 hours, while, patients who will show persistent headache will be subjected for bilateral ultrasound guided greater occipital nerve block. then these patients will be assessed after 1 h, 6 h, and 24 h of the block. If still suffering epidural blood patch will be indicated and performed after gaining patients' consent. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient acceptance.
- Age 21- 40 years old.
- Post-partum females suffering PDPH with visual analogue score (VAS) ≥ 4 and modified Lybecker classification score ≥ 2
- ASA II (due to pregnancy).
- Body mass index < 35Kg/m2
Key exclusion criteria (6 listed)
- Emergent cesarean section.
- Hypertensive disorders of the pregnancy.
- History of allergy to local anesthetics.
- History of chronic headache, migraine, convulsions, and cerebrovascular accident.
- Contraindication to spinal anesthesia: coagulopathy, infection at site of injection.
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 transnasal sphenopalatine ganglion block.Also: (SPG) block.SPG block will be performed with the patient in supine position using cotton-tipped plastic hollow applicator inserted in the nose with the swab soaked in 1.5 ml 10%lignocaine. The applicator will be inserted parallel to the floor of the nose until resistance encountered. The swab will be rested in the pterygopalatine fossa superior to the middle turbinate and removed after 10 min. This procedure will be repeated in the other nostril too. | Procedure or surgery | Interventional group |
| Bilateral ultrasound guided greater occipital nerve block.Also: (GONB).GONB will be performed with the patients lying in prone position using high frequency (6-13 MHz) probe of Siemens Acuson X300 machine placed in transverse orientation lateral to external occipital protuberance parallel to the superior nuchal line to detect occipital artery where the nerve is located medial to it 1.5inch; then 20 gauge needle will be inserted out of plane to avoid vascular injury. 4 ml of treatment solution containing 2.5 mg/ml bupivacaine and 1 mg/ml dexamethasone (prepared by adding 2 ml bupivacaine 0.5% + 1 ml dexamethasone + 1 ml saline) will be injected on each side. | Procedure or surgery | Interventional group |
Primary outcome
visual analogue scale
Time frame: 24 hours
pain score
1 secondary outcome
Trans-Carnial Doppler
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 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.
Sherif Mo Mowafy, MD study director
Assistant professor of Anesthesia & Surgical Intensive Care Faculty of Medicine - Zagazig University
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 transnasal sphenopalatine ganglion block. and Bilateral ultrasound guided greater occipital nerve block. in people with Post-Dural Puncture Headache, run by Zagazig 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 18 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
visual analogue scale (time frame: 24 hours). 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 18 Oct 2022.