Postdural Puncture HeadacheNCT06380764
Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache
A study testing Greater Occipital Nerve Block, Bilateral suboccipital intramuscular injection and Epidural Blood Patch in people with Postdural Puncture Headache, run by Benha University at 1 site in Egypt.
Trial summary
Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Postdural Puncture Headache
- What is being tested?
- Greater Occipital Nerve Block, Bilateral suboccipital intramuscular injection and Epidural Blood Patch
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2023to 1 Dec 2023
- 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 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with postdural puncture headache;
- Patients partially improved on conservative treatment and required a definitive pain relieving management;
- Patients who were intolerant to conventional analgesics;
- Patients who did not receive or did not improve on conservative therapies.
Who cannot join
- Patients had postdural puncture headache who were improving on conservative treatment and refused further interventions;
- Patients who had headache secondary to local or systemic disease, cervical radiculopathy, manifest diabetes mellitus;
- Patients dependent on routine analgesia for other causes were excluded from the study;
- Patients refused to participate in the study or to sign the written consent;
- Patients missed during follow-up were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Greater Occipital Nerve Block at Two-levels Spares the Need for Epidural Blood Patch for Management of Postdural Puncture Headache
Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.
Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region.
- Conditions
- Postdural Puncture Headache
- Being tested
- Greater Occipital Nerve Block, Bilateral suboccipital intramuscular injection, Epidural Blood Patch, Normal Saline 10 mL Injection, Lidocaine 2% Injectable Solution
- 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.
Greater Occipital Nerve BlockProcedure or surgery
The occipital artery was localized, while the patient was setting with flexed neck, at the point of meeting of the medial third and the lateral two-thirds of a line drawn extending from the ipsilateral mastoid process to the external occipital protuberance and the GON was located on the medial side of the artery where it exits out of the trapezius fascia into the nuchal line about 5-cm lateral to midline.
For assurance of GON localization, pressure was applied and the resultant tenderness indicated the site of the nerve. Injection procedure was performed as distal injection at the site of nerve localization and proximal injection was performed at 1.5 cm lateral to the sagittal plane and 3 cm below to the level of the external occipital protuberance.
Bilateral suboccipital intramuscular injectionProcedure or surgery
Sub-occipital intramuscular injection of the prepared solution was carried out on both sides while the patient was setting with maximally flexing the neck to expose these muscles.
Epidural Blood PatchProcedure or surgery
Patients showed manifestations of block failure within 24-h after block, received lumbar Epidural blood patch under non-invasive monitoring in the theater. Patient was positioned in the lateral decubitus position, lumbar area was sterilized and the epidural space previously used for receiving the previous neuraxial anesthesia was identified. Fifteen ml of venous blood was obtained aseptically and slowly injected while patient was monitored for the extent of pain severity until complete pain relief.
Normal Saline 10 mL InjectionDrug
Placebo drug
Lidocaine 2% Injectable SolutionDrug
Lidocaine is the main drug used in the interventions as it was injected to achieve bilateral block or intramuscular infiltration
| Study group | Role | What they receive |
|---|---|---|
| First line Group | Active comparator | Not described Receives: Procedure: Greater Occipital Nerve Block; Drug: Lidocaine 2% Injectable Solution |
| Second line Group | Active comparator | Not described Receives: Procedure: Bilateral suboccipital intramuscular injection; Drug: Lidocaine 2% Injectable Solution |
| Third line Group | Active comparator | Not described Receives: Procedure: Epidural Blood Patch |
| Placebo Group | Placebo comparator | Not described Receives: Drug: Normal Saline 10 mL Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of reduction of consumed analgesia
Necessity of greater occipital nerve block as a management procedure to the postural puncture headache
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start2 Mar 2023
- Primary completion25 Jul 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postdural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Benha 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehia Shahin Dabour, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380764
- Sponsor's protocol ID
- RC.11.3.2024
- Status last verified
- Apr 2024
- First submitted
- 13 Apr 2024
- Last updated
- 24 Apr 2024
- 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 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Greater Occipital Nerve Block at Two-levels Spares the Need for Epidural Blood Patch for Management of Postdural Puncture Headache
- ClinicalTrials.gov ID
- NCT06380764
- Acronym / sponsor ID
- RC.11.3.2024
- Conditions
- Postdural Puncture Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 24 Apr 2024 (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.
Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.
Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| First line Group | Active comparator | Procedure: Greater Occipital Nerve Block, Drug: Lidocaine 2% Injectable Solution |
| Second line Group | Active comparator | Procedure: Bilateral suboccipital intramuscular injection, Drug: Lidocaine 2% Injectable Solution |
| Third line Group | Active comparator | Procedure: Epidural Blood Patch |
| Placebo Group | Placebo comparator | Drug: Normal Saline 10 mL Injection |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with postdural puncture headache;
- Patients partially improved on conservative treatment and required a definitive pain relieving management;
- Patients who were intolerant to conventional analgesics;
- Patients who did not receive or did not improve on conservative therapies.
Key exclusion criteria (5 listed)
- Patients had postdural puncture headache who were improving on conservative treatment and refused further interventions;
- Patients who had headache secondary to local or systemic disease, cervical radiculopathy, manifest diabetes mellitus;
- Patients dependent on routine analgesia for other causes were excluded from the study;
- Patients refused to participate in the study or to sign the written consent;
- Patients missed during follow-up were not included in the study.
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 |
|---|---|---|
| Greater Occipital Nerve BlockThe occipital artery was localized, while the patient was setting with flexed neck, at the point of meeting of the medial third and the lateral two-thirds of a line drawn extending from the ipsilateral mastoid process to the external occipital protuberance and the GON was located on the medial side of the artery where it exits out of the trapezius fascia into the nuchal line about 5-cm lateral to midline. For assurance of GON localization, pressure was applied and the resultant tenderness indicated the site of the nerve. Injection procedure was performed as distal injection at the site of nerve localization and proximal injection was performed at 1.5 cm lateral to the sagittal plane and 3 cm below to the level of the external occipital protuberance. | Procedure or surgery | First line Group |
| Bilateral suboccipital intramuscular injectionSub-occipital intramuscular injection of the prepared solution was carried out on both sides while the patient was setting with maximally flexing the neck to expose these muscles. | Procedure or surgery | Second line Group |
| Epidural Blood PatchPatients showed manifestations of block failure within 24-h after block, received lumbar Epidural blood patch under non-invasive monitoring in the theater. Patient was positioned in the lateral decubitus position, lumbar area was sterilized and the epidural space previously used for receiving the previous neuraxial anesthesia was identified. Fifteen ml of venous blood was obtained aseptically and slowly injected while patient was monitored for the extent of pain severity until complete pain relief. | Procedure or surgery | Third line Group |
| Normal Saline 10 mL InjectionPlacebo drug | Drug | Placebo Group |
| Lidocaine 2% Injectable SolutionLidocaine is the main drug used in the interventions as it was injected to achieve bilateral block or intramuscular infiltration | Drug | First line Group, Second line Group |
Primary outcome
The extent of reduction of consumed analgesia
Time frame: 7 months
Necessity of greater occipital nerve block as a management procedure to the postural puncture headache
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 24 Apr 2024.
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Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Greater Occipital Nerve Block, Bilateral suboccipital intramuscular injection and Epidural Blood Patch in people with Postdural Puncture Headache, run by Benha 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 4 inclusion and 5 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 24 Apr 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. Some participants in this study may receive a placebo. 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?
The extent of reduction of consumed analgesia (time frame: 7 months). 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 24 Apr 2024.