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

NCT03464253 | Completed

• 1 other identifier: 4372/25-2-2018
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postdural Puncture Headache

Outcome Measures

Primary Outcomes (1)

• 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 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.

  5 days

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant female undergoing Elective caesarean section under spinal anesthesia.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, 44111, Egypt

Location

Related Publications (10)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 25146108 BACKGROUND

• Turnbull 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.

  PMID: 14570796 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 30065464 BACKGROUND

• 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. No abstract available.

  PMID: 28012860 BACKGROUND

• 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.

  PMID: 21935623 BACKGROUND

• Mowafy 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.

  PMID: 31073654 DERIVED

MeSH Terms

Conditions

Post-Dural Puncture Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shereen E Abd Ellatif, MD

  Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University

  STUDY DIRECTOR

• Sherif MS Mowafy, MD

  Anesthesia and Surgical Intensive Care Department, faculty of medicine, Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Anesthesia and Surgical Intensive Care

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 13, 2018
• Study Start: April 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: October 30, 2018
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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

Locations

EG (1)