SGB in Management of Patients With PDPH Using TCD

Not Applicable

Completed

• Conditions: Post-Dural Puncture Headache
• Interventions: Drug: Sphenopalatine Ganglion Block using 2% lidocaine

• Registration Number: NCT04401878
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-20
• Study Start: 2020-05-24
• Study First Posted: 2020-05-26
• Primary Completion: 2020-09-20
• Study Completion: 2020-09-20
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-18
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the treatment group (A)	Sphenopalatine Ganglion Block using 2% lidocaine	Patients who have PDPH are manged by SPGB, they are assessed by NRS before the block, at 30 mins, 2h, 4h, 6h, 12h, and 24hours after block. The patients are also examined by TCD before and after the block.
control group (B)	Sphenopalatine Ganglion Block using 2% lidocaine	The control group (B) of 60 patients with no PDPH were examined by TCD

Primary Outcome Measures

Name	Time	Method
pain changes assessment by numeric rating scale (NRS)	Before the block and at 30 minutes, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after the block	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.

Secondary Outcome Measures

Name	Time	Method
Detecting the changes in cerebral vessels caliber after doing SPGB	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.	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

Trial Locations

Locations (1)

Faculty of Medicine, Zagazig University; 🇪🇬 Zagazig, Egypt