Postdural Puncture HeadacheNCT03464253
Prediction of Post-dural Puncture Headache in Parturients Undergoing Elective Caesarean Section
An observational study of Postdural Puncture Headache, run by Zagazig University at 1 site in Egypt.
Trial summary
The parturients are at particular risk of post dural puncture headache (PDPH) because of their sex, young age, and the widespread application of spinal and epidural anesthesia. PDPH has a negative impact on quality of life, patient satisfaction, the postpartum experience with the mother's inability to bond with and… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postdural Puncture Headache
- What is being tested?
- Performance of the transcranial Doppler (TCD)
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 30 Oct 2018
- How long will I take part?
- 5 Days
- Phase
- Observational
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant female undergoing Elective caesarean section under spinal anesthesia.
Who may be able to join
- Patient acceptance.
- Pregnant female undergoing Elective caesarean section under spinal anesthesia.
- Age 18-40 years old.
- ASA I and ASA II.
- Accepted mental state of the patient.
Who cannot join
- Patient refusal.
- Contraindications to regional anesthesia as local infection, coagulopathy,….etc
- ASA Grade 3 and 4.
- Emergent caesarean section.
- Inadequate temporal window.
- Hypertensive disorders of the pregnancy.
Show all 9Show fewer
- Atrial fibrillation.
- Significant fetal illness.
- History of allergy to local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcranial Doppler Role in Prediction of Post-dural Puncture Headache in Parturients Undergoing Elective Caesarean Section
The parturients are at particular risk of post dural puncture headache (PDPH) because of their sex, young age, and the widespread application of spinal and epidural anesthesia. PDPH has a negative impact on quality of life, patient satisfaction, the postpartum experience with the mother's inability to bond with and care for her baby and it increases the economic burden associated with childbirth. Therefore, it is necessary to prevent or decrease its incidence and severity.
TCD enables measurement of the blood flow velocity in intracranial arteries and its parameters are affected by both fluctuations in intracranial pressure and changes in cerebral vessel diameters. The possibility of equipment mobilization, the opportunity of repeated bedside technique together with the noninvasive nature, makes TCD measurements attractive in the attempt to estimate CBF and offers potential application to predict and follow patients with PDPH.
Read the detailed description
PDPH is described as severe "searing and spreading like hot metal" distributed over the occipital and frontal areas radiating to the neck and shoulders. 90% of headache will occur within three days of the procedure, and 66% within the first 48 hours. The PDPH rarely develops between 5 and 14 days after the technique however it may immediately occur after dural puncture but it is rare and should pay attention of the physician to alternative causes. The pain is increased by head movement, upright posture and relieved by lying down. It resolves either spontaneously within 7 days or within 48 h after effective treatment which is usually consists of fluid therapy, analgesics, sumatriptan and caffeine. Epidural blood patch remained the gold standard therapy but it is an invasive technique.
The exact etiology of PDPH is unknown; there is two hypothesis attempts to explain the cause. First it's known that dural tear leads to cerebrospinal fluid (CSF) leak and decreased volume of CSF result in intracranial hypotension which cause on pain sensitive intracranial structures that become stretched when assuming upright position result in pain. Second, intracranial volume is constant and equal to the sum of intracranial blood, CSF, and brain matter. After loss of CSF a compensatory reflex vasodilatation occur in the same pain sensitive blood vessels and this result in pain.
The association of common risk factors like female gender, particularly females during pregnancy, age groups of 20 - 40 years, a prior history of chronic headache, and a lower body mass index expose the patient to PDPH. The identification of factors that predict the likelihood of PDPH is important so that measures can be taken to minimize this painful complication resulting from spinal anesthesia.
Transcranial Doppler ultrasound (TCD) is a portable, safe, noninvasive and real-time tool for assessing intracranial blood hemodynamics. The first description of the technique was by Rune Aaslid in early 20th century and it has gained increasing acceptance as an accurate diagnostic and therapeutic tool in both cerebrovascular disease and neurocritical care. TCD enables measurement of the blood flow velocity in intracranial arteries and several Studies have shown that its parameters are affected by both fluctuations in intracranial pressure and changes in cerebral vessel diameters. So, as PDPH may be resulted from significant changes in cerebral blood flow, it could be visualized by TCD.
The possibility of equipment mobilization, the opportunity of repeated bedside technique together with the noninvasive nature, makes TCD measurements attractive in the attempt to estimate CBF and offers potential application to predict and follow patients with PDPH.
- Conditions
- Postdural Puncture Headache
- Being tested
- Performance of the transcranial Doppler (TCD)
- 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.
Performance of the transcranial Doppler (TCD)Device
Within 24 hour before the operation, TCD is performed using Siemens Acuson X300 machine with ultrasound frequency is 1 - 5 MHz probe to measure Mean Velocity and Pulsatility Index in the right middle cerebral artery.postoperatively, TCD study is performed twice at 24h and 48h after spinal anesthesia. For 5 days postoperatively, the Patients are assessed clinically for the occurrence of headache. Patients who developed PDPH will be identified and their pre and post puncture measurements will be compared with the corresponding measurements of PDPH free patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
TCD is able to predict the occurrence of PDPH in female patients undergoing spinal anesthesia for elective Caesarean Section
The group of patients who developed PDPH will be identified and their pre puncture cerebral blood flow measurements by TCD will be compared with the corresponding measurements of PDPH free patients to correlate the pre-puncture measurements with the occurrence of PDPH.
Measured: 5 days
Secondary outcomes (1)
verify that lumber puncture in PDPH patients leads to significant changes in cerebral blood flow supporting the theory of cerebral vasodilatation in PDPH patients.
The post-puncture TCD measurements will be compared to verify that lumber puncture and CSF leak leads to reflex vasodilatation in PDPH patients.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Postdural 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sherif M. S. Mowafy, Zagazig University
- Investigators
- Shereen E Abd Ellatif, MD, Study director, Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig UniversitySherif MS Mowafy, MD, Principal investigator, Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464253
- Sponsor's protocol ID
- 4372/25-2-2018
- Status last verified
- Jan 2019
- First submitted
- 28 Feb 2018
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Mohammed EL and El Shal SM. Efficacy of different size Quincke spinal needles in reduction of incidence of Post-Dural Puncture Headache (PDPH) in Caesarean Section (CS). Randomized controlled study. Egyptian Journal of Anaesthesia 33: 53-58, 2017
Shah A, Bhatia PK, Tulsiani KL. Post dural puncture headache in caesarean section-a comparative study using 25G Quincke, 27G Quincke and 27G Whitacre needle. Indian J Anaesth 46(5):373-377, 2002
Bardon J, LE Ray C, Samama CM, Bonnet MP. Risk factors of post-dural puncture headache receiving a blood patch in obstetric patients. Minerva Anestesiol. 2016 Jun;82(6):641-8. Epub 2015 Jul 29.
PubMed 26222393Sachs A, Smiley R. Post-dural puncture headache: the worst common complication in obstetric anesthesia. Semin Perinatol. 2014 Oct;38(6):386-94. doi: 10.1053/j.semperi.2014.07.007. Epub 2014 Aug 19.
PubMed 25146108Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. doi: 10.1093/bja/aeg231.
PubMed 14570796Kracoff SL and Kotlovker V. Post Dural Puncture Headache-Review and Suggested New Treatment. Open Journal of Anesthesiology 6: 148-163, 2016
Venturelli PM, Brunser AM, Gaete J, Illanes S, Lopez J, Olavarria VV, Reccius A, Brinck P, Gonzalez F, Cavada G, Lavados PM. Reliability of Hand-Held Transcranial Doppler with M-mode Ultrasound in Middle Cerebral Artery Measurement. J Med Ultrasound. 2017 Apr-Jun;25(2):76-81. doi: 10.1016/j.jmu.2016.12.001. Epub 2017 Jan 4.
PubMed 30065464Vadhera RB, Babazade R, Suresh MS, Alvarado MC, Cruz AL, Belfort MA. Role of transcranial Doppler measurements in postpartum patients with post-dural puncture headache: a pilot study. Int J Obstet Anesth. 2017 Feb;29:90-91. doi: 10.1016/j.ijoa.2016.10.010. Epub 2016 Nov 4. No abstract available.
PubMed 28012860Nowaczewska M, Ksiazkiewicz B. Cerebral blood flow characteristics in patients with post-lumbar puncture headache. J Neurol. 2012 Apr;259(4):665-9. doi: 10.1007/s00415-011-6236-1. Epub 2011 Sep 21.
PubMed 21935623Mowafy SMS, Abd Ellatif SE. Transcranial Doppler role in prediction of post-dural puncture headache in parturients undergoing elective cesarean section: prospective observational study. J Anesth. 2019 Jun;33(3):426-434. doi: 10.1007/s00540-019-02652-2. Epub 2019 May 9.
PubMed 31073654
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Doppler Role in Prediction of Post-dural Puncture Headache in Parturients Undergoing Elective Caesarean Section
- ClinicalTrials.gov ID
- NCT03464253
- Acronym / sponsor ID
- 4372/25-2-2018
- Conditions
- Postdural Puncture Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 13 Mar 2018 (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.
The parturients are at particular risk of post dural puncture headache (PDPH) because of their sex, young age, and the widespread application of spinal and epidural anesthesia. PDPH has a negative impact on quality of life, patient satisfaction, the postpartum experience with the mother's inability to bond with and care for her baby and it increases the economic burden associated with childbirth. Therefore, it is necessary to prevent or decrease its incidence and severity.
TCD enables measurement of the blood flow velocity in intracranial arteries and its parameters are affected by both fluctuations in intracranial pressure and changes in cerebral vessel diameters. The possibility of equipment mobilization, the opportunity of repeated bedside technique together with the noninvasive nature, makes TCD measurements attractive in the attempt to estimate CBF and offers potential application to predict and follow patients with PDPH.
Detailed description
PDPH is described as severe "searing and spreading like hot metal" distributed over the occipital and frontal areas radiating to the neck and shoulders. 90% of headache will occur within three days of the procedure, and 66% within the first 48 hours. The PDPH rarely develops between 5 and 14 days after the technique however it may immediately occur after dural puncture but it is rare and should pay attention of the physician to alternative causes. The pain is increased by head movement, upright posture and relieved by lying down. It resolves either spontaneously within 7 days or within 48 h after effective treatment which is usually consists of fluid therapy, analgesics, sumatriptan and caffeine. Epidural blood patch remained the gold standard therapy but it is an invasive technique.
The exact etiology of PDPH is unknown; there is two hypothesis attempts to explain the cause. First it's known that dural tear leads to cerebrospinal fluid (CSF) leak and decreased volume of CSF result in intracranial hypotension which cause on pain sensitive intracranial structures that become stretched when assuming upright position result in pain. Second, intracranial volume is constant and equal to the sum of intracranial blood, CSF, and brain matter. After loss of CSF a compensatory reflex vasodilatation occur in the same pain sensitive blood vessels and this result in pain.
The association of common risk factors like female gender, particularly females during pregnancy, age groups of 20 - 40 years, a prior history of chronic headache, and a lower body mass index expose the patient to PDPH. The identification of factors that predict the likelihood of PDPH is important so that measures can be taken to minimize this painful complication resulting from spinal anesthesia.
Transcranial Doppler ultrasound (TCD) is a portable, safe, noninvasive and real-time tool for assessing intracranial blood hemodynamics. The first description of the technique was by Rune Aaslid in early 20th century and it has gained increasing acceptance as an accurate diagnostic and therapeutic tool in both cerebrovascular disease and neurocritical care. TCD enables measurement of the blood flow velocity in intracranial arteries and several Studies have shown that its parameters are affected by both fluctuations in intracranial pressure and changes in cerebral vessel diameters. So, as PDPH may be resulted from significant changes in cerebral blood flow, it could be visualized by TCD.
The possibility of equipment mobilization, the opportunity of repeated bedside technique together with the noninvasive nature, makes TCD measurements attractive in the attempt to estimate CBF and offers potential application to predict and follow patients with PDPH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant female undergoing Elective caesarean section under spinal anesthesia.
Key inclusion criteria (5 listed)
- Patient acceptance.
- Pregnant female undergoing Elective caesarean section under spinal anesthesia.
- Age 18-40 years old.
- ASA I and ASA II.
- Accepted mental state of the patient.
Key exclusion criteria (9 listed)
- Patient refusal.
- Contraindications to regional anesthesia as local infection, coagulopathy,….etc
- ASA Grade 3 and 4.
- Emergent caesarean section.
- Inadequate temporal window.
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 |
|---|---|---|
| Performance of the transcranial Doppler (TCD)Within 24 hour before the operation, TCD is performed using Siemens Acuson X300 machine with ultrasound frequency is 1 - 5 MHz probe to measure Mean Velocity and Pulsatility Index in the right middle cerebral artery.postoperatively, TCD study is performed twice at 24h and 48h after spinal anesthesia. For 5 days postoperatively, the Patients are assessed clinically for the occurrence of headache. Patients who developed PDPH will be identified and their pre and post puncture measurements will be compared with the corresponding measurements of PDPH free patients. | Device | – |
Primary outcome
TCD is able to predict the occurrence of PDPH in female patients undergoing spinal anesthesia for elective Caesarean Section
Time frame: 5 days
The group of patients who developed PDPH will be identified and their pre puncture cerebral blood flow measurements by TCD will be compared with the corresponding measurements of PDPH free patients to correlate the pre-puncture measurements with the occurrence of PDPH.
1 secondary outcome
verify that lumber puncture in PDPH patients leads to significant changes in cerebral blood flow supporting the theory of cerebral vasodilatation in PDPH patients.
Time frame: 5 days
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 15 Jan 2019.
- BackgroundMohammed EL and El Shal SM. Efficacy of different size Quincke spinal needles in reduction of incidence of Post-Dural Puncture Headache (PDPH) in Caesarean Section (CS). Randomized controlled study. Egyptian Journal of Anaesthesia 33: 53-58, 2017
- BackgroundShah A, Bhatia PK, Tulsiani KL. Post dural puncture headache in caesarean section-a comparative study using 25G Quincke, 27G Quincke and 27G Whitacre needle. Indian J Anaesth 46(5):373-377, 2002
- Background: PubMed 26222393Bardon J, LE Ray C, Samama CM, Bonnet MP. Risk factors of post-dural puncture headache receiving a blood patch in obstetric patients. Minerva Anestesiol. 2016 Jun;82(6):641-8. Epub 2015 Jul 29.
- Background: PubMed 25146108Sachs A, Smiley R. Post-dural puncture headache: the worst common complication in obstetric anesthesia. Semin Perinatol. 2014 Oct;38(6):386-94. doi: 10.1053/j.semperi.2014.07.007. Epub 2014 Aug 19.
- Background: PubMed 14570796Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. doi: 10.1093/bja/aeg231.
- BackgroundKracoff SL and Kotlovker V. Post Dural Puncture Headache-Review and Suggested New Treatment. Open Journal of Anesthesiology 6: 148-163, 2016
- Background: PubMed 30065464Venturelli PM, Brunser AM, Gaete J, Illanes S, Lopez J, Olavarria VV, Reccius A, Brinck P, Gonzalez F, Cavada G, Lavados PM. Reliability of Hand-Held Transcranial Doppler with M-mode Ultrasound in Middle Cerebral Artery Measurement. J Med Ultrasound. 2017 Apr-Jun;25(2):76-81. doi: 10.1016/j.jmu.2016.12.001. Epub 2017 Jan 4.
- Background: PubMed 28012860Vadhera RB, Babazade R, Suresh MS, Alvarado MC, Cruz AL, Belfort MA. Role of transcranial Doppler measurements in postpartum patients with post-dural puncture headache: a pilot study. Int J Obstet Anesth. 2017 Feb;29:90-91. doi: 10.1016/j.ijoa.2016.10.010. Epub 2016 Nov 4. No abstract available.
- Background: PubMed 21935623Nowaczewska M, Ksiazkiewicz B. Cerebral blood flow characteristics in patients with post-lumbar puncture headache. J Neurol. 2012 Apr;259(4):665-9. doi: 10.1007/s00415-011-6236-1. Epub 2011 Sep 21.
- Derived from this study: PubMed 31073654Mowafy SMS, Abd Ellatif SE. Transcranial Doppler role in prediction of post-dural puncture headache in parturients undergoing elective cesarean section: prospective observational study. J Anesth. 2019 Jun;33(3):426-434. doi: 10.1007/s00540-019-02652-2. Epub 2019 May 9.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Postdural Puncture Headache
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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.
Shereen E Abd Ellatif, MD study director
Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University
Sherif MS Mowafy, MD principal investigator
Anesthesia and Surgical Intensive Care Department, 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?
An observational study of Postdural 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 5 inclusion and 9 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 15 Jan 2019. 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?
TCD is able to predict the occurrence of PDPH in female patients undergoing spinal anesthesia for elective Caesarean Section (time frame: 5 days). 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 NCT03464253, which also lists 10 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 15 Jan 2019.