Transcranial Doppler Role in Prediction of Post-dural Puncture Headache in Parturients Undergoing Elective Caesarean Section

Prediction of Post-dural Puncture Headache in Parturients Undergoing Elective Caesarean Section



Sponsors

Lead Sponsor



Source

Zagazig University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief 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 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.

Overall Status

Recruiting

Start Date

2018-04-01

Completion Date

2018-10-30

Primary Completion Date

2018-07-01

Study Type

Observational [Patient Registry]

Primary Outcome

Measure

Time Frame

TCD is able to predict the occurrence of PDPH in female patients undergoing spinal anesthesia for elective Caesarean Section
5 days

Secondary Outcome

Measure

Time Frame

verify that lumber puncture in PDPH patients leads to significant changes in cerebral blood flow supporting the theory of cerebral vasodilatation in PDPH patients.
5 days

Enrollment

90

Condition


Intervention

Intervention Type

Device

Intervention Name


Description

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.


Eligibility

Study Pop

Pregnant female undergoing Elective caesarean section under spinal anesthesia.

Sampling Method

Probability Sample

Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- Atrial fibrillation.

- Significant fetal illness.

- History of allergy to local anesthetics.

Gender

Female

Minimum Age

18 Years

Maximum Age

40 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

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

Overall Contact

Last Name

Sherif MS Mowafy, MD

Phone

01003523374

Phone Ext

002

Email

sherifmowafy2012@gmail.com


Location

Facility

Status

Contact

Zagazig University Hospitals
Zagazig Sharkia 44111 Egypt
Recruiting
Last Name: Shereen E Abd Ellatif, MD
Phone: 01007948840
Phone Ext: 002
Email: shosh.again@gmail.com

Location Countries

Country

Egypt


Verification Date

2018-04-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Zagazig University

Investigator Full Name

Sherif M. S. Mowafy

Investigator Title

lecturer of Anesthesia and Surgical Intensive Care


Has Expanded Access

No

Condition Browse


Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Shereen E Abd Ellatif, MD

Phone

01007948840

Phone Ext

002

Email

shosh.again@gmail.com


Reference

Citation

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


Citation

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


Citation

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.

PMID

26222393


Citation

Sachs 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. Review.

PMID

25146108


Citation

Turnbull DK, Shepherd DB. Post-dural puncture headache: pathogenesis, prevention and treatment. Br J Anaesth. 2003 Nov;91(5):718-29. Review.

PMID

14570796


Citation

Kracoff SL and Kotlovker V. Post Dural Puncture Headache—Review and Suggested New Treatment. Open Journal of Anesthesiology 6: 148-163, 2016


Citation

Venturelli PM, Brunser AM, Gaete J, Illanes S, López J, Olavarría VV, Reccius A, Brinck P, González 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.

PMID

30065464


Citation

Vadhera 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.

PMID

28012860


Citation

Nowaczewska M, Książkiewicz 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.

PMID

21935623



Target Duration

5 Days

Patient Data

Sharing Ipd

Yes

Ipd Description

all IPD that underlie results in a publication

Ipd Info Type

Study Protocol

Statistical Analysis Plan (SAP)

Informed Consent Form (ICF)

Clinical Study Report (CSR)

Analytic Code


Ipd Time Frame

the IPD and any additional supporting information will become available starting 6 months after publication.

Ipd Access Criteria

by contacting the study director


Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective


Study First Submitted

February 28, 2018

Study First Submitted Qc

March 12, 2018

Study First Posted

March 13, 2018

Last Update Submitted

April 27, 2018

Last Update Submitted Qc

April 27, 2018

Last Update Posted

May 1, 2018


ClinicalTrials.gov processed this data on August 24, 2018

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Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

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In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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