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Trial Title:
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
NCT ID:
NCT06244056
Condition:
Stellate Ganglion Block
Conditions: Official terms:
Ganglion Cysts
Synovial Cyst
Heart Failure
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A stellate ganglion block is performed by a medical professional in a sterile setting.
Firstly Position of patient: Semi-lateral decubitus position, with the neck turned
contralateral. Using Probe of ultrasound: Linear 6-13 MHz to guide the needle to the
stellate ganglion , The skin at the injection site is cleaned with an antiseptic solution
to reduce the risk of infection. A local anesthetic is injected into the skin and deeper
tissues to numb the area. Needle:25G 1.5 inch or 22G 3.5 inch is inserted through the
skin and deeper tissues until it reaches the stellate ganglion.Once the needle is in the
correct position, 3-5 mL of local anesthetic (0.25-0.5% bupivacaine) The procedure
typically takes about 15-20 minutes.
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Investigator)
Intervention:
Intervention type:
Procedure
Intervention name:
Stellate Ganglion Block
Description:
A stellate ganglion block is performed by a medical professional in a sterile setting.
Firstly Position of patient: Semi-lateral decubitus position, with the neck turned
contralateral. Using Probe of ultrasound: Linear 6-13 MHz to guide the needle to the
stellate ganglion , The skin at the injection site is cleaned with an antiseptic solution
to reduce the risk of infection. A local anesthetic is injected into the skin and deeper
tissues to numb the area. Needle:25G 1.5 inch or 22G 3.5 inch is inserted through the
skin and deeper tissues until it reaches the stellate ganglion.Once the needle is in the
correct position, 3-5 mL of local anesthetic (0.25-0.5% bupivacaine) The procedure
typically takes about 15-20 minutes.
Arm group label:
: Narrow QRS complex Heart failure patients
Arm group label:
Wide QRS complex heart failure patients
Summary:
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
Detailed description:
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18 : 70 years old.
- NYHA Class III-IV Heart Failure.
- Heart failure with a reduced ejection fraction (HFrEF) LVEF ≤ 40% calculated using
2D echocardiography and Biplane Simpson's .
- Optimal tolerated Medical Therapy for Heart Failure.
Exclusion Criteria:
- Active Malignancy.
- Acute heart failure including pulmonary edema or cardiogenic shock.
- Severe, life-threatening non-cardiac disease.
- Pregnancy.
- Localized infection.
- Coagulopathy or anticoagulated patients.
- Refused this procedure.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Assiut University
Address:
City:
Assiut
Zip:
71515
Country:
Egypt
Status:
Not yet recruiting
Facility:
Name:
Assiut university
Address:
City:
Assiut
Zip:
71515
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Mina Fam, Resident
Phone:
+201122035368
Email:
minassfam@yahoo.com
Start date:
February 5, 2024
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Mina sobhi said fam
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06244056
