SGB in Management of Patients With PDPH Using TCD

NCT ID: NCT04401878

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-24
• Study Completion Date: 2020-09-20

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.

Conditions

Post-Dural Puncture Headache

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sphenopalatine Ganglion Block using 2% lidocaine

Intervention Type: 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.

control group (B)

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

Group Type: EXPERIMENTAL

Sphenopalatine Ganglion Block using 2% lidocaine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Transcranial Doppler (TCD) is also utilized

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Naglaa Fathy Abdelhaleem Abdelhaleem

Lecturer, Anesthesia and Surgical Intensive Care department, Faculty of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naglaa Abdelhaleem, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Zagazig University, Zagazig, Egypt.

Locations

Faculty of Medicine, Zagazig University

Zagazig, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 26176166 (View on PubMed)

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

Reference Type: RESULT

Other Identifiers

6140

Identifier Type: OTHER

Identifier Source: secondary_id

6140

Identifier Type: -

Identifier Source: org_study_id