SGB in Management of Patients With PDPH Using TCD

Zagazig University120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Post-Dural Puncture Headache

Interventions

Sphenopalatine Ganglion Block using 2% lidocaineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Medicine, Zagazig University

Zagazig, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 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

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

Time frame: 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.

Data from ClinicalTrials.gov

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