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Completed

NCT Number: NCT04401878

SGB in Management of Patients With PDPH Using TCD

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.

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Key information

Conditions

Post-Dural Puncture Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Zagazig University

Zagazig, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Transcranial Doppler (TCD) is also utilized

Primary outcomes

  1. pain changes assessment by numeric rating scale (NRS)

    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

    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 outcomes

  1. Detecting the changes in cerebral vessels caliber after doing SPGB

    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.

    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

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 26, 2020
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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