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

Postdural Puncture Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464253
• Other study ID #: 4372/25-2-2018
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: January 2019
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 30, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache
• Postdural Puncture Headache

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitals	Zagazig	Sharkia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (9)

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. — View Citation

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

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

Nowaczewska 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. — View 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. — View 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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	5 days
Secondary	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.	5 days