SGB in Management of Patients With PDPH Using TCD

Post-Dural Puncture Headache Clinical Trial

Official title:

Verification of Sphenopalatine Ganglion Block Success Using Transcranial Doppler in Management of Patients With Post Dural Puncture Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401878
• Other study ID #: 6140
• Secondary ID: 6140
• Status: Completed
• Phase: N/A
• Start date: May 24, 2020
• Est. completion date: September 20, 2020

Study information

• Verified date: July 2021
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 20, 2020
• Est. primary completion date: September 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Post-Dural Puncture Headache

Intervention

Drug:
• Sphenopalatine Ganglion Block using 2% lidocaine
Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril. The patients are then examined by TCD.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Zagazig University	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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/

Basurto Ona X, Osorio D, Bonfill Cosp X. Drug therapy for treating post-dural puncture headache. Cochrane Database Syst Rev. 2015 Jul 15;(7):CD007887. doi: 10.1002/14651858.CD007887.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain changes assessment by numeric rating scale (NRS)	Pain score changes are assessed before and after the block using NRS in which zero is no pain and ten is worst pain imagined. pain was assessed throughout 24 hours after performing the block and Pain relief is considered when NRS = 4.	Before the block and at 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after the block
Secondary	Detecting the changes in cerebral vessels caliber after doing SPGB	Siemens Acuson X300 ultrasound with P 4-2 phased array 2MHz probe was utilized. For all patients, both middle cerebral arteries were insonated through the transtemporal window over the zygomatic arch in front of the tragus of the ear at a depth of 50-60 mm. Tracings were also recorded for at least 10 cardiac cycles	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.