Back to resultsSGB in Management of Patients With PDPH Using TCD
Primary Purpose
Post-Dural Puncture Headache
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sphenopalatine Ganglion Block using 2% lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Post-Dural Puncture Headache focused on measuring Accidental dural puncture, Post dural puncture headache, Sphenopalatine ganglion block, Transcranial Doppler
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.
Sites / Locations
- Faculty of Medicine, Zagazig University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
the treatment group (A)
control group (B)
Arm Description
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.
The control group (B) of 60 patients with no PDPH were examined by TCD
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04401878
Brief Title
SGB in Management of Patients With PDPH Using TCD
Official Title
Verification of Sphenopalatine Ganglion Block Success Using Transcranial Doppler in Management of Patients With Post Dural Puncture Headache
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 24, 2020 (Actual)
Primary Completion Date
September 20, 2020 (Actual)
Study Completion Date
September 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache
Keywords
Accidental dural puncture, Post dural puncture headache, Sphenopalatine ganglion block, Transcranial Doppler
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Care ProviderOutcomes Assessor
Masking Description
Double (Care Providor, Outcome Assessor)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the treatment group (A)
Arm Type
Experimental
Arm Description
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.
Arm Title
control group (B)
Arm Type
Experimental
Arm Description
The control group (B) of 60 patients with no PDPH were examined by TCD
Intervention Type
Drug
Intervention Name(s)
Sphenopalatine Ganglion Block using 2% lidocaine
Other Intervention Name(s)
Transcranial Doppler (TCD) is also utilized
Intervention Description
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.
Primary Outcome Measure Information:
Title
pain changes assessment by numeric rating scale (NRS)
Description
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 Outcome Measure Information:
Title
Detecting the changes in cerebral vessels caliber after doing SPGB
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naglaa Abdelhaleem, MD
Organizational Affiliation
Faculty of Medicine, Zagazig University, Zagazig, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine, Zagazig University
City
Zagazig
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://ClinicalTrials.gov
Citations:
PubMed Identifier
26176166
Citation
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.
Results Reference
background
Citation
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
Results Reference
result
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SGB in Management of Patients With PDPH Using TCD
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