SGB in Management of Patients With PDPH Using TCD

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

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.

Study Overview

• Status: Completed
• Conditions: Post-Dural Puncture Headache
• Intervention / Treatment: Drug: Sphenopalatine Ganglion Block using 2% lidocaine

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Faculty of medicine, Zagazig university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the treatment group (A); 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.	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.; Other Names: Transcranial Doppler (TCD) is also utilized
Experimental: control group (B); The control group (B) of 60 patients with no PDPH were examined by TCD	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.; Other Names: Transcranial Doppler (TCD) is also utilized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Naglaa Abdelhaleem, MD, Faculty of Medicine, Zagazig University, Zagazig, Egypt.

Publications and helpful links

General Publications

• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2020
• Primary Completion (Actual): September 20, 2020
• Study Completion (Actual): September 20, 2020

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Transcranial Doppler; Sphenopalatine ganglion block; Accidental dural puncture; Post dural puncture headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Dural Puncture Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 6140 (Other Identifier: Faculty of Medicine, Zagazig University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: it will be available after completion of study and publication
• IPD Sharing Time Frame: The data will be available 3 months after publication of study
• IPD Sharing Access Criteria: By contacting the principal investigator
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No