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

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT03464253

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

12.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postdural Puncture Headache	Device: Performance of the transcranial Doppler (TCD)

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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2018

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Oct 30, 2018

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
The post-puncture TCD measurements will be compared to verify that lumber puncture and CSF leak leads to reflex vasodilatation in PDPH patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zagazig University Hospitals	Zagazig	Sharkia	Egypt	44111

Sponsors and Collaborators

Zagazig University

Investigators

Study Director: Shereen E Abd Ellatif, MD, Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University
Principal Investigator: Sherif MS Mowafy, MD, Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Sherif M. S. Mowafy, lecturer of Anesthesia and Surgical Intensive Care, Zagazig University

ClinicalTrials.gov Identifier:

NCT03464253

Other Study ID Numbers:

4372/25-2-2018

First Posted:

Mar 13, 2018

Last Update Posted:

Jan 15, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Post-Dural Puncture Headache

Headache

Study Results

No Results Posted as of Jan 15, 2019