- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07814703
Intercostobrachial Nerve Block vs Erector Spinae Block for Medial Arm A-V Fistula Surgery
Comparison Between Ultrasound-guided Intercostobrachial Nerve Block With Supraclavicular Block Versus Ultrasound -Guided Erector Spinae Block With Supraclavicular Block for Medial Arm A-V Fistula Surgery: Observer Blinded Randomized Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Intravenous access will be obtained with an 18-gauge intravenous (IV) cannula in the contralateral upper limb of the surgical site and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure and capnography) will be applied.
All patients will receive 5 L/min of oxygen was delivered via a face mask.
In all patients, the SCPB was performed before the assigned supplemental block. Patients were placed supine with the head turned approximately 30° away from the surgical side and a small towel positioned between the scapulae to optimize access. After aseptic preparation, a high-frequency linear US probe (6 - 12 MHz) of ultrasound US machine (LOGIQ P7) covered with a sterile sheath was placed in the coronal-oblique plane just superior to the clavicle and lateral to the sternocleidomastoid muscle to visualize the subclavian artery medially, the brachial plexus divisions as a cluster of hypoechoic round structures lateral to the artery, and the first rib and pleura as hyperechoic lines deep to the artery.
Lidocaine 1% was injected at the entry site of the needle, Using an in-plane lateral-to-medial approach, a 22-G, 80-mm insulated block needle was advanced under continuous US guidance toward the "corner pocket" bordered by the subclavian artery medially, the first rib inferiorly, and the brachial plexus laterally. After negative aspiration, 5 - 10 mL of was injected into the corner pocket, and the needle was redirected to deposit additional 3 - 5 mL aliquots around the remaining plexus divisions to ensure circumferential spread, for a total of a mixture of 15 ml each of 0.5% bupivacaine and 2% lidocaine.
In group (I), following the SCPB, the intercostobrachial nerve (ICBN) was blocked using Ultrasound-Guided Intercostobrachial Nerve Block Procedure after SCPB, the ICBN was blocked under US guidance at the mid-axillary level. The patient was positioned supine with the arm abducted to 90°. A high-frequency linear probe (6 - 12 MHz) was placed transversely over the mid-axillary line at the level of the 2nd-3rd intercostal spaces. The axillary vein and artery were first visualized, then the probe was adjusted superficially to identify the fascial plane between the subcutaneous tissue and the serratus anterior muscle.
The ICBN appeared as a small hyperechoic oval or linear structure within this plane. Using an in-plane, posterio-anterior needle approach, an 80-mm block needle was advanced into the fascial plane. After confirming negative aspiration, 10 ml of the same local anesthetic mixture was administered (0.5% bupivacaine and 2% lidocaine), and real-time sonographic imaging confirmed the spread of local anesthetic along the plane both anteriorly and posteriorly.
In group (E) for the ultrasound-guided erector spinae plane block. At first the patient will be placed in a lateral decubitus with the operation site up and we will count the vertebrae from cephalad to caudal direction until we reach T2 spinous process as the first palpable spinous process is C7. Ultrasound probe will be placed vertically 3 cm lateral to the T2 spinous process. linear transducer was placed on the superior-posterior aspect of the operation site shoulder close to the neck to observe the short axis view of the transverse processes of T2 and T3. The same type of block needle was inserted and advanced in a caudad-to-cephalad direction toward the space between the two transverse processes using in-plane ultrasound guidance. Immediately after penetrating the anterior fascia of the erector spinae muscles, 10 ml of the same local anesthetic mixture was administered.
Twenty minutes after the completion of the nerve blocks, a pinprick test showed that the entire upper arm and lateral aspect of the left upper chest wall were anesthetized. Thereafter, surgery was initiated.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: taghreed shabaan korany, assistant lecturer
- Phone Number: 00201007195396
- Email: Taghreedshaban60@gmail.com
Study Contact Backup
- Name: Amr hamdy Mahmoud, lecturer
- Phone Number: 00201004349592
- Email: amrhamdy69@gmail.com
Study Locations
-
-
Madīnat Al Fayyūm, Faiyum Governorate
-
Al Fayyum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 4312
- Recruiting
- Fayoum University Hospital
-
Contact:
- taghreed shabaan korany, Msc
- Phone Number: 00201007195396
- Email: Taghreedshaban60@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ESRD patient undergoing creation AVF in the medial side of the arm.
Exclusion Criteria:
- 1. Patient refusal 2. Drug allergies 3. Body Mass Index of 35 kg/m² or more 4. Coagulation abnormalities 5. Severe heart, kidney, and liver diseases, 6. Pregnancy 7. Vasculitis 8. Unstable hemodynamics 9. Upper extremity neuropathy 10. Mental illness 11. Seizures 12. Contralateral chest problems 13. Infection at site of injection
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: intercostobrachial nerve block
|
the intercostobrachial nerve will be blocked using Ultrasound-Guided Procedure after SCPB, the ICBN was blocked under US guidance at the mid-axillary level.
The patient was positioned supine with the arm abducted to 90°.
A high-frequency linear probe will be placed transversely over the mid-axillary line at the level of the 2nd-3rd intercostal spaces.
The axillary vein and artery were first visualized, then the probe was adjusted superficially to identify the fascial plane between the subcutaneous tissue and the serratus anterior muscle.
The ICBN appeared as a small hyperechoic oval or linear structure within this plane.
Using an in-plane, posterio-anterior needle approach, an 80-mm block needle was advanced into the fascial plane.
After confirming negative aspiration, 10 ml of the same local anesthetic mixture was administered (0.5% bupivacaine and 2% lidocaine)
|
|
Active Comparator: ultrasound-guided erector spinae plane block
|
patient will be placed in a lateral decubitus with the operation site up and we will count the vertebrae from cephalad to caudal direction until we reach T2 spinous process as the first palpable spinous process is C7.
Ultrasound probe will be placed vertically 3 cm lateral to the T2 spinous process.
linear transducer was placed on the superior-posterior aspect of the operation site shoulder close to the neck to observe the short axis view of the transverse processes of T2 and T3.
The same type of block needle was inserted and advanced in a caudad-to-cephalad direction toward the space between the two transverse processes using in-plane ultrasound guidance.
Immediately after penetrating the anterior fascia of the erector spinae muscles, 10 ml of the same local anesthetic mixture was administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
achievement of complete sensory block
Time Frame: 20 minutes after the completion of the nerve blocks
|
pinprick test showed that the entire upper arm and lateral aspect of the left upper chest wall are anesthetized
|
20 minutes after the completion of the nerve blocks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: mohamed ahmed Ismail, professor, Faculty of medicine,Fayoum University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- D475
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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