Clinical trial NCT04401878: SGB in Management of Patients With PDPH Using TCD
Official title: Verification of Sphenopalatine Ganglion Block Success Using Transcranial Doppler in Management of Patients With Post Dural Puncture Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Dural Puncture Headache
Keywords: Accidental dural puncture
Post dural puncture headache
Sphenopalatine ganglion block
Transcranial Doppler
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is carried out in the Orthopedic unit and included 120 patients divided into two groups: the treatment group (A) and the control group (B). Group A recruit 60 patients with a past history of epidural anesthesia who suffered from of PDPH within five days after the dural puncture. Group B included 60 patients with a history of epidural anesthesia with no PDPH.
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the ability of SPGB in the management of PDPH. Transcranial Doppler is also used as an measure to assess the block success by detecting the variability in the cerebral hemodynamics before and after the block.

Detailed description: This clinical trial is performed in postoperative orthopedic unit. In this study, 120 patients were enrolled who had an epidural anesthesia; 60 patients who developed PDPH joined the treatment group (A) and received the SP block. They are assessed before the procedure by NRS and at 30 mins, 2h, 4h, 6h, 12h, and 24h after the procedure. Patients are also assessed by TCD before and after the block. The control group (B) included 60 patients with no PDPH.

Eligibility criteria: Inclusion Criteria:

* patients are considered who had an epidural anesthesia
* Patients with ASA 1 and 2
* Patients' age ranged from 18 to 60 years.

Exclusion Criteria:

* Patients with septal perforation, nasal septum deviation,or nasal bleeding.
* Patients have recent nasal trauma
* Patients have recent nasal surgery
* Patients have a nasal infection
* Patients within ASA 3 and 4
* Patients older than sixty yrs or younger than eighteen yrs.

Primary outcomes:
measure: pain changes assessment by numeric rating scale (NRS)
timeFrame: Before the block and at 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after the block
Secondary outcomes:
measure: Detecting the changes in cerebral vessels caliber after doing SPGB
timeFrame: TCD measurements are performed before SPGB is given to both groups, it is repeated again within an hour after the block for group (A) only.
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Medicine, Zagazig University
Study officials:
affiliation: Faculty of Medicine, Zagazig University, Zagazig, Egypt.
name: Naglaa Abdelhaleem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Basurto Ona X, Osorio D, Bonfill Cosp X. Drug therapy for treating post-dural puncture headache. Cochrane Database Syst Rev. 2015 Jul 15;2015(7):CD007887. doi: 10.1002/14651858.CD007887.pub3.
citation: Abdelhaleem NF, Othman HA, Abdel Razek GM, et al. (2019). Is the Combination of Glasgow Coma Scale and Transcranial Doppler Pulsatility Index Improving the Prediction of Outcome in Traumatic Brain Injury Patients? ZUMJ, 2019, 25(5): 529-538, doi:10.21608/zumj.2019.10082.10740