Post-Dural Puncture HeadacheNCT06470854
Effect of Nebulized Dexmedetomidine on Post-dural Puncture Headache
A study testing Nebulized Dexmedetomidine and Bilateral greater occipital nerve block in people with Post-Dural Puncture Headache, run by Tanta University at 1 site in Egypt.
Trial summary
Dural puncture during neuroaxial procedures is the most frequent major complication that causes the development of post-dural puncture headache (PDPH) in 16%-86% of cases. PDPH could be defined as severe positional headache that usually presents during the first 72-h following accidental dural puncture. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Nebulized Dexmedetomidine and Bilateral greater occipital nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 22 Mar 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women had CS under spinal anesthesia;
- Women started to complain of PDPH;
- Women were free of exclusion criteria.
Who cannot join
- Women had prior history of PDPH or headache for any cause;
- Women had essential hypertension;
- Women with previous history of habitual hypotension or accidental syncope secondary to postural hypotension;
- Women with tempromandibular disorders;
- Women who refused to participate in the study were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nebulized Dexmedetomidine for Post-dural Puncture Headache: A Comparative Case-Control Study Versus Bilateral Greater Occipital Nerve Block
Dural puncture during neuroaxial procedures is the most frequent major complication that causes the development of post-dural puncture headache (PDPH) in 16%-86% of cases. PDPH could be defined as severe positional headache that usually presents during the first 72-h following accidental dural puncture.
Dexmedetomidine (DXM) is a potent and highly selective α2-adrenergic agonist that was approved for ICU and procedural sedation in adults. Additionally, DXM has pleiotropic effects for its sympatholytic, amnestic, and analgesic properties. Regarding routes of administrations, DXM allows high flexibility and can be administered through intravenous (IV), intramuscular, buccal, intranasal and inhalational routes.
Read more
Nebulized DXM at 1 µg/kg is a favorable alternative to the intravenous route in short duration surgeries because it attenuates heart rate response to laryngoscopy. However, the effects of nebulized DXM on blood pressure are controversial.
it was assured that it has a role in reduction of the intraoperative anesthetic requirements and analgesic consumption.
The prophylactic and management strategies for PDPH are heterogeneous because of the absence of clear guidelines and protocols for the management of PDPH. However, the general plan for PDPH management consists of conservative treatment and if failed invasive procedures such as blood patch were applied.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Nebulized Dexmedetomidine, Bilateral 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.
Nebulized DexmedetomidineDrug
Nebulized Dexmedetomidine was prepared to provide 1 µg/kg and the calculated dose of DXM was diluted by 4-ml of 0.9% saline and was provided in the nebulizer to be nebulized in twice daily; i.e. every 12 hours for 72 hours
Bilateral greater occipital nerve blockProcedure or surgery
The injection solution was prepared by mixing 2-ml of 2% lidocaine with 2-ml (8 mg) of dexamethasone. A line was drawn extending between the mastoid process and the external occipital protuberance, this line was divided as a medial third and lateral two-thirds to localize the occipital artery and the greater occipital nerve 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 and injection was performed bilaterally to achieve bilateral block.
| Study group | Role | What they receive |
|---|---|---|
| Group One | Active comparator | Not described Receives: Drug: Nebulized Dexmedetomidine |
| Group Two | Active comparator | Not described Receives: Procedure: Bilateral greater occipital nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The extent of reduction of consumed analgesia
Efficacy of both modalities for relieve of Post Dural Puncture Headache in the women who included in the study.
Measured: 5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 Nov 2023
- Primary completion20 Feb 2024
- Study completion22 Mar 2024
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 Tanta 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Lotfy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470854
- Sponsor's protocol ID
- 36264PR665/4/24
- Status last verified
- Jun 2024
- First submitted
- 18 Jun 2024
- Last updated
- 24 Jun 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 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Dexmedetomidine for Post-dural Puncture Headache: A Comparative Case-Control Study Versus Bilateral Greater Occipital Nerve Block
- ClinicalTrials.gov ID
- NCT06470854
- Acronym / sponsor ID
- 36264PR665/4/24
- Conditions
- Post-Dural Puncture Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 24 Jun 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.
Dural puncture during neuroaxial procedures is the most frequent major complication that causes the development of post-dural puncture headache (PDPH) in 16%-86% of cases. PDPH could be defined as severe positional headache that usually presents during the first 72-h following accidental dural puncture.
Dexmedetomidine (DXM) is a potent and highly selective α2-adrenergic agonist that was approved for ICU and procedural sedation in adults. Additionally, DXM has pleiotropic effects for its sympatholytic, amnestic, and analgesic properties. Regarding routes of administrations, DXM allows high flexibility and can be administered through intravenous (IV), intramuscular, buccal, intranasal and inhalational routes.
Nebulized DXM at 1 µg/kg is a favorable alternative to the intravenous route in short duration surgeries because it attenuates heart rate response to laryngoscopy. However, the effects of nebulized DXM on blood pressure are controversial.
it was assured that it has a role in reduction of the intraoperative anesthetic requirements and analgesic consumption.
The prophylactic and management strategies for PDPH are heterogeneous because of the absence of clear guidelines and protocols for the management of PDPH. However, the general plan for PDPH management consists of conservative treatment and if failed invasive procedures such as blood patch were applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group One | Active comparator | Drug: Nebulized Dexmedetomidine |
| Group Two | Active comparator | Procedure: Bilateral greater occipital nerve block |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women had CS under spinal anesthesia;
- Women started to complain of PDPH;
- Women were free of exclusion criteria.
Key exclusion criteria (5 listed)
- Women had prior history of PDPH or headache for any cause;
- Women had essential hypertension;
- Women with previous history of habitual hypotension or accidental syncope secondary to postural hypotension;
- Women with tempromandibular disorders;
- Women who refused to participate in the study were excluded.
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 |
|---|---|---|
| Nebulized DexmedetomidineNebulized Dexmedetomidine was prepared to provide 1 µg/kg and the calculated dose of DXM was diluted by 4-ml of 0.9% saline and was provided in the nebulizer to be nebulized in twice daily; i.e. every 12 hours for 72 hours | Drug | Group One |
| Bilateral greater occipital nerve blockThe injection solution was prepared by mixing 2-ml of 2% lidocaine with 2-ml (8 mg) of dexamethasone. A line was drawn extending between the mastoid process and the external occipital protuberance, this line was divided as a medial third and lateral two-thirds to localize the occipital artery and the greater occipital nerve 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 and injection was performed bilaterally to achieve bilateral block. | Procedure or surgery | Group Two |
Primary outcome
The extent of reduction of consumed analgesia
Time frame: 5 Months
Efficacy of both modalities for relieve of Post Dural Puncture Headache in the women who included in the study.
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 Jun 2024.
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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 Nebulized Dexmedetomidine and Bilateral greater occipital nerve block in people with Post-Dural Puncture Headache, run by Tanta 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 3 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 Jun 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?
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: 5 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 Jun 2024.