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

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ClinicalTrials.gov Identifier: NCT03464253
Recruitment Status : Completed
First Posted : March 13, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sherif M. S. Mowafy, Zagazig University

Tracking Information
First Submitted Date February 28, 2018
First Posted Date March 13, 2018
Last Update Posted Date January 15, 2019
Actual Study Start Date April 1, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03464253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 12, 2018)
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 ]
The post-puncture TCD measurements will be compared to verify that lumber puncture and CSF leak leads to reflex vasodilatation in PDPH patients.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prediction of Post-dural Puncture Headache in Parturients Undergoing Elective Caesarean Section
Official Title Transcranial Doppler Role in Prediction of Post-dural Puncture Headache in Parturients Undergoing Elective Caesarean Section
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Days
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Pregnant female undergoing Elective caesarean section under spinal anesthesia.
Condition 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.
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 12, 2018)
90
Original Estimated Enrollment Same as current
Actual Study Completion Date October 30, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03464253
Other Study ID Numbers 4372/25-2-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: the IPD and any additional supporting information will become available starting 6 months after publication.
Access Criteria: by contacting the study director
Responsible Party Sherif M. S. Mowafy, Zagazig University
Study Sponsor Zagazig University
Collaborators Not Provided
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
PRS Account Zagazig University
Verification Date January 2019