SGB in Management of Patients With PDPH Using TCD

NCT04401878 | Completed DMC

• 1 other identifier: 6140
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Dural Puncture Headache

Keywords

Accidental dural puncture; Post dural puncture headache; Sphenopalatine ganglion block; Transcranial Doppler

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

the treatment group (A)

EXPERIMENTAL

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

control group (B)

EXPERIMENTAL

The control group (B) of 60 patients with no PDPH were examined by TCD

Drug: Sphenopalatine Ganglion Block using 2% lidocaine

Interventions

Sphenopalatine Ganglion Block using 2% lidocaine DRUG

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.

Also known as: Transcranial Doppler (TCD) is also utilized

control group (B); the treatment group (A)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Medicine, Zagazig University

Zagazig, 44519, Egypt

Location

Related Publications (2)

• 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.

  PMID: 26176166 BACKGROUND

• 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

  RESULT

MeSH Terms

Conditions

Post-Dural Puncture Headache

Interventions

Lidocaine; Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Naglaa Abdelhaleem, MD

  Faculty of Medicine, Zagazig University, Zagazig, Egypt.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double (Care Providor, Outcome Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 26, 2020
• Study Start: May 24, 2020
• Primary Completion: September 20, 2020
• Study Completion: September 20, 2020
• Last Updated: July 22, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available 3 months after publication of study
• Access Criteria: By contacting the principal investigator

Locations

EG (1)