Post-Dural Puncture HeadacheNCT04401878
SGB in Management of Patients With PDPH Using TCD
A study testing Sphenopalatine Ganglion Block using 2% lidocaine in people with Post-Dural Puncture Headache, run by Zagazig University at 1 site in Egypt.
Trial summary
This study aims to investigate the ability of SPGB in the management of PDPH. Transcranial Doppler is also used as an measure to assess the block success by detecting the variability in the cerebral hemodynamics before and after the block. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-Dural Puncture Headache
- What is being tested?
- Sphenopalatine Ganglion Block using 2% lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 24 May 2020to 20 Sep 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients are considered who had an epidural anesthesia
- Patients with ASA 1 and 2
- Patients' age ranged from 18 to 60 years.
Who cannot join
- Patients with septal perforation, nasal septum deviation,or nasal bleeding.
- Patients have recent nasal trauma
- Patients have recent nasal surgery
- Patients have a nasal infection
- Patients within ASA 3 and 4
- Patients older than sixty yrs or younger than eighteen yrs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Verification of Sphenopalatine Ganglion Block Success Using Transcranial Doppler in Management of Patients With Post Dural Puncture Headache
This study aims to investigate the ability of SPGB in the management of PDPH. Transcranial Doppler is also used as an measure to assess the block success by detecting the variability in the cerebral hemodynamics before and after the block.
Read the detailed description
This clinical trial is performed in postoperative orthopedic unit. In this study, 120 patients were enrolled who had an epidural anesthesia; 60 patients who developed PDPH joined the treatment group (A) and received the SP block. They are assessed before the procedure by NRS and at 30 mins, 2h, 4h, 6h, 12h, and 24h after the procedure. Patients are also assessed by TCD before and after the block. The control group (B) included 60 patients with no PDPH.
- Conditions
- Post-Dural Puncture Headache
- Being tested
- Sphenopalatine Ganglion Block using 2% lidocaine
- Keywords
- Accidental dural puncture, Post dural puncture headache, Sphenopalatine ganglion block, Transcranial Doppler
- 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 Block using 2% lidocaineDrug
Also called Transcranial Doppler (TCD) is also utilized
Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril. The patients are then examined by TCD.
| Study group | Role | What they receive |
|---|---|---|
| the treatment group (A) | Experimental | Patients who have PDPH are manged by SPGB, they are assessed by NRS before the block, at 30 mins, 2h, 4h, 6h, 12h, and 24hours after block. The patients are also examined by TCD before and after the block. Receives: Drug: Sphenopalatine Ganglion Block using 2% lidocaine |
| control group (B) | Experimental | The control group (B) of 60 patients with no PDPH were examined by TCD Receives: Drug: Sphenopalatine Ganglion Block using 2% lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain changes assessment by numeric rating scale (NRS)
Pain score changes are assessed before and after the block using NRS in which zero is no pain and ten is worst pain imagined. pain was assessed throughout 24 hours after performing the block and Pain relief is considered when NRS ≤ 4.
Measured: Before the block and at 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after the block
Secondary outcomes (1)
Detecting the changes in cerebral vessels caliber after doing SPGB
Siemens Acuson X300 ultrasound with P 4-2 phased array 2MHz probe was utilized. For all patients, both middle cerebral arteries were insonated through the transtemporal window over the zygomatic arch in front of the tragus of the ear at a depth of 50-60 mm. Tracings were also recorded for at least 10 cardiac cycles
Measured: TCD measurements are performed before SPGB is given to both groups, it is repeated again within an hour after the block for group (A) only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2020
- Study start24 May 2020
- Primary completion20 Sep 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study is carried out in the Orthopedic unit and included 120 patients divided into two groups: the treatment group (A) and the control group (B). Group A recruit 60 patients with a past history of epidural anesthesia who suffered from of PDPH within five days after the dural puncture. Group B included 60 patients with a history of epidural anesthesia with no PDPH.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Naglaa Fathy Abdelhaleem Abdelhaleem, Zagazig University
- Investigators
- Naglaa Abdelhaleem, MD, Principal investigator, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04401878
- Sponsor's protocol ID
- 6140
- Other IDs
- 6140
- Status last verified
- Jul 2021
- First submitted
- 18 May 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: it will be available after completion of study and publication
Publications
Basurto Ona X, Osorio D, Bonfill Cosp X. Drug therapy for treating post-dural puncture headache. Cochrane Database Syst Rev. 2015 Jul 15;2015(7):CD007887. doi: 10.1002/14651858.CD007887.pub3.
PubMed 26176166Abdelhaleem NF, Othman HA, Abdel Razek GM, et al. (2019). Is the Combination of Glasgow Coma Scale and Transcranial Doppler Pulsatility Index Improving the Prediction of Outcome in Traumatic Brain Injury Patients? ZUMJ, 2019, 25(5): 529-538, doi:10.21608/zumj.2019.10082.10740
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Sphenopalatine Ganglion Block Success Using Transcranial Doppler in Management of Patients With Post Dural Puncture Headache
- ClinicalTrials.gov ID
- NCT04401878
- Acronym / sponsor ID
- 6140
- Conditions
- Post-Dural Puncture Headache
- Keywords
- Accidental dural puncture, Post dural puncture headache, Sphenopalatine ganglion block, Transcranial Doppler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 24 May 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 26 May 2020 (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.
This study aims to investigate the ability of SPGB in the management of PDPH. Transcranial Doppler is also used as an measure to assess the block success by detecting the variability in the cerebral hemodynamics before and after the block.
Detailed description
This clinical trial is performed in postoperative orthopedic unit. In this study, 120 patients were enrolled who had an epidural anesthesia; 60 patients who developed PDPH joined the treatment group (A) and received the SP block. They are assessed before the procedure by NRS and at 30 mins, 2h, 4h, 6h, 12h, and 24h after the procedure. Patients are also assessed by TCD before and after the block. The control group (B) included 60 patients with no PDPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is carried out in the Orthopedic unit and included 120 patients divided into two groups: the treatment group (A) and the control group (B). Group A recruit 60 patients with a past history of epidural anesthesia who suffered from of PDPH within five days after the dural puncture. Group B included 60 patients with a history of epidural anesthesia with no PDPH.
| Arm | Type | Receives |
|---|---|---|
| the treatment group (A) | Experimental | Drug: Sphenopalatine Ganglion Block using 2% lidocainePatients who have PDPH are manged by SPGB, they are assessed by NRS before the block, at 30 mins, 2h, 4h, 6h, 12h, and 24hours after block. The patients are also examined by TCD before and after the block. |
| control group (B) | Experimental | Drug: Sphenopalatine Ganglion Block using 2% lidocaineThe control group (B) of 60 patients with no PDPH were examined by TCD |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients are considered who had an epidural anesthesia
- Patients with ASA 1 and 2
- Patients' age ranged from 18 to 60 years.
Key exclusion criteria (6 listed)
- Patients with septal perforation, nasal septum deviation,or nasal bleeding.
- Patients have recent nasal trauma
- Patients have recent nasal surgery
- Patients have a nasal infection
- Patients within ASA 3 and 4
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 Block using 2% lidocaineAlso: Transcranial Doppler (TCD) is also utilizedSphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril. The patients are then examined by TCD. | Drug | control group (B), the treatment group (A) |
Primary outcome
pain changes assessment by numeric rating scale (NRS)
Time frame: Before the block and at 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after the block
Pain score changes are assessed before and after the block using NRS in which zero is no pain and ten is worst pain imagined. pain was assessed throughout 24 hours after performing the block and Pain relief is considered when NRS ≤ 4.
1 secondary outcome
Detecting the changes in cerebral vessels caliber after doing SPGB
Time frame: TCD measurements are performed before SPGB is given to both groups, it is repeated again within an hour after the block for group (A) only.
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 22 Jul 2021.
- Background: PubMed 26176166Basurto Ona X, Osorio D, Bonfill Cosp X. Drug therapy for treating post-dural puncture headache. Cochrane Database Syst Rev. 2015 Jul 15;2015(7):CD007887. doi: 10.1002/14651858.CD007887.pub3.
- Results publicationAbdelhaleem NF, Othman HA, Abdel Razek GM, et al. (2019). Is the Combination of Glasgow Coma Scale and Transcranial Doppler Pulsatility Index Improving the Prediction of Outcome in Traumatic Brain Injury Patients? ZUMJ, 2019, 25(5): 529-538, doi:10.21608/zumj.2019.10082.10740
- Individual participant dataSharing planned: Yes. it will be available after completion of study and publication
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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.
Naglaa Abdelhaleem, MD principal investigator
Faculty of Medicine, Zagazig University, Zagazig, Egypt.
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 using 2% lidocaine 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 3 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 22 Jul 2021. 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?
pain changes assessment by numeric rating scale (NRS) (time frame: Before the block and at 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after the block). 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 NCT04401878, which also lists 2 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 22 Jul 2021.