Post-Dural Puncture HeadacheNCT05253014
Different Approaches for the Management of Post-dural Puncture Headache
A study testing sphenopalatine ganglion block and paracetamol in people with Post-Dural Puncture Headache, run by Bahaa Mohammed Refaie at 1 site in Egypt.
Trial summary
Detecting the efficacy and safety of trans-nasal sphenopalatine ganglion block using either lidocaine 2% or bupivacaine 0.5 % as a treatment line for post-dural puncture headache Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- sphenopalatine ganglion block and paracetamol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 30 Dec 2020
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The ASA physical condition І-П
- the patient underwent CS under spinal anesthesia
- The headache developed within 5 days after the dural puncture
- There is no different explanation for the headache
Who cannot join
- coagulopathy
- history of nasal bleeding
- nasal polyp
- septal deviation
- local anesthetics reaction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Different Approaches for the Management of Post-dural Puncture Headache
Detecting the efficacy and safety of trans-nasal sphenopalatine ganglion block using either lidocaine 2% or bupivacaine 0.5 % as a treatment line for post-dural puncture headache
- Conditions
- Post-Dural Puncture Headache
- Being tested
- sphenopalatine ganglion block, paracetamol
- 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.
sphenopalatine ganglion blockProcedure or surgery
block of the sphenopalatine ganglion using either lidocaine or bupivacaine to relief postdural puncture headache
paracetamolDrug
intravenous paracetamol every 8 hours
| Study group | Role | What they receive |
|---|---|---|
| lidocaine group | Active comparator | Not described Receives: Procedure: sphenopalatine ganglion block |
| bupivacaine group | Active comparator | Not described Receives: Procedure: sphenopalatine ganglion block |
| conservative group | Active comparator | Not described Receives: Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
postdural puncture headache
visual analog scale
Measured: within five days after the dural puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Jan 2018
- Primary completion30 Oct 2020
- Study completion30 Dec 2020
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahaa Mohammed Refaie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bahaa Mohammed Refaie, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253014
- Sponsor's protocol ID
- 2223
- Status last verified
- Feb 2022
- First submitted
- 5 Feb 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Different Approaches for the Management of Post-dural Puncture Headache
- ClinicalTrials.gov ID
- NCT05253014
- Acronym / sponsor ID
- 2223
- Conditions
- Post-Dural Puncture Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bahaa Mohammed RefaieUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 23 Feb 2022 (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.
Detecting the efficacy and safety of trans-nasal sphenopalatine ganglion block using either lidocaine 2% or bupivacaine 0.5 % as a treatment line for post-dural puncture headache
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lidocaine group | Active comparator | Procedure: sphenopalatine ganglion block |
| bupivacaine group | Active comparator | Procedure: sphenopalatine ganglion block |
| conservative group | Active comparator | Drug: paracetamol |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The ASA physical condition І-П
- the patient underwent CS under spinal anesthesia
- The headache developed within 5 days after the dural puncture
- There is no different explanation for the headache
Key exclusion criteria (5 listed)
- coagulopathy
- history of nasal bleeding
- nasal polyp
- septal deviation
- local anesthetics reaction
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 |
|---|---|---|
| sphenopalatine ganglion blockblock of the sphenopalatine ganglion using either lidocaine or bupivacaine to relief postdural puncture headache | Procedure or surgery | bupivacaine group, lidocaine group |
| paracetamolintravenous paracetamol every 8 hours | Drug | conservative group |
Primary outcome
postdural puncture headache
Time frame: within five days after the dural puncture
visual analog scale
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 23 Feb 2022.
- Individual participant dataSharing planned: Undecided
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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 sphenopalatine ganglion block and paracetamol in people with Post-Dural Puncture Headache, run by Bahaa Mohammed Refaie 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 23 Feb 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?
postdural puncture headache (time frame: within five days after the dural puncture). 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 23 Feb 2022.