Intercostobrachial Nerve BlockNCT06500572
Landmark Guided Intercostobrachial Nerve Block Versus Serratus Plane Block After Supraclavicular Plexus Block for Anesthesia in Creation of Arteriovenous Fistula in the Medial Side of the Arm
A study testing Landmark Guided Intercostobrachial Nerve Block, Ultrasound Guided Intercostobrachial Nerve Block and Serratus Plane Block in people with Intercostobrachial Nerve Block and Serratus Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to compare the role of ultrasound-guided and landmark-guided intercostobrachial nerve block and serratus plane block after supraclavicular plexus block for anesthesia in the creation of an arteriovenous fistula in the medial side of the arm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intercostobrachial Nerve Block, Serratus Plane Block, Supraclavicular Plexus Block
- What is being tested?
- Landmark Guided Intercostobrachial Nerve Block, Ultrasound Guided Intercostobrachial Nerve Block and Serratus Plane Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jul 2024to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for creation of arteriovenous fistula in the medial side of the arm.
Who cannot join
- Allergy to local anesthetics.
- Drug addiction.
- Coagulation abnormalities.
- Body Mass Index (BMI)≥35 kg/m2.
- Upper extremity neuropathy.
- Vasculitis.
Show all 10Show fewer
- Unstable hemodynamics.
- History of seizures or mental illness.
- Severe heart, kidney, and liver diseases.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided, Landmark Guided Intercostobrachial Nerve Block Versus Serratus Plane Block After Supraclavicular Plexus Block for Anesthesia in Creation of Arteriovenous Fistula in the Medial Side of the Arm: A Randomized Trial
This study aims to compare the role of ultrasound-guided and landmark-guided intercostobrachial nerve block and serratus plane block after supraclavicular plexus block for anesthesia in the creation of an arteriovenous fistula in the medial side of the arm.
Read the detailed description
Brachial plexus block (BPB) is usually utilized for proximal arm arteriovenous access creation. It has been suggested that supraclavicular brachial plexus block (SCPB) could be an alternative and provide comparable effective anesthesia and postoperative analgesia for arm surgery, with a reduced incidence of adverse events, including hemidiaphragmatic paresis.
By performing SCPB, the inner part of the arm is not completely anesthetized because this part of the arm is innervated by the lateral cutaneous branch of the second intercostal nerve (intercostobrachial nerve (ICBN)) and the medial branch of the brachial cutaneous nerve.
Serratus plane block (SPB) was first defined in 2013 by Blanco et al. This block provides anesthesia and analgesia in the hemi-thorax, where it is applied to block the thoracic intercostal nerves, in addition to the axillary region and shoulder posteriorly.
- Conditions
- Intercostobrachial Nerve Block, Serratus Plane Block, Supraclavicular Plexus Block, Arteriovenous Fistula
- Being tested
- Landmark Guided Intercostobrachial Nerve Block, Ultrasound Guided Intercostobrachial Nerve Block, Serratus Plane Block
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Landmark Guided Intercostobrachial Nerve BlockOther
In addition to the supraclavicular plexus block, the intercostobrachial nerve block block will be performed without ultrasound guidance and based on the traditional method using superficial anatomy and nerve pathway by subcutaneous injection of 20 mL of bupivacaine 0.25% at the site of the pulse.
Ultrasound Guided Intercostobrachial Nerve BlockOther
The patient's head will be turned to the opposite side while the patient is in the supine position and the shoulder to be treated will be elevated 5- 10 cm. The high-frequency linear ultrasound probe (12-4 MHz) and the region to be treated will be prepared in sterile conditions and placed transversely across the external jugular vein at 3-4 cm above the clavicle. Between the anterior and middle scalene muscles, the imaging of the brachial plexus showed three to five hypoechoic circles. The entry will be in-plane technique using an 80-mm block needle from lateral to medial. After confirming the needle insertion site with 2 mL saline solution, a 20 mL bupivacaine 0.25% will be administered.
Serratus Plane BlockOther
The patient will be placed in the lateral decubitus position with the area to be treated on the upper side. The high-frequency linear ultrasound probe and the region to be treated will be sterilized. The ultrasound probe will be placed on the anterior line at the level of fourth and fifth ribs. Images of the muscle's latissimus dorsi and serratus anterior, the ribs, and the pleura will be obtained. Subsequently, with the in-plane technique, an 80-mm block needle will be advanced between the latissimus dorsi and the serratus muscles planes in a caudal to the cranial direction. There is no blood or air in aspiration. After confirming the location of the needle with 2 mL of saline solution, (20 mL of bupivacaine 0.25%) will be administered between the two muscles.
| Study group | Role | What they receive |
|---|---|---|
| Landmark Guided Intercostobrachial Nerve Block | Active comparator | In addition to the supraclavicular plexus block, the intercostobrachial nerve block block will be performed without ultrasound guidance and based on the traditional method using superficial anatomy and nerve pathway by subcutaneous injection of 20 mL of bupivacaine 0.25% at the site of the pulse. Receives: Other: Landmark Guided Intercostobrachial Nerve Block |
| Ultrasound Guided Intercostobrachial Nerve Block | Experimental | The patient's head will be turned to the opposite side while the patient is in the supine position and the shoulder to be treated will be elevated 5- 10 cm. The high-frequency linear ultrasound probe (12-4 MHz) and the region to be treated will be prepared in sterile conditions and placed transversely across the external jugular vein at 3-4 cm above the clavicle. Between the anterior and middle scalene muscles, the imaging of the brachial plexus showed three to five hypoechoic circles. The entry will be in-plane technique using an 80-mm block needle from lateral to medial. After confirming the needle insertion site with 2 mL saline solution, a 20 mL bupivacaine 0.25% will be administered. Receives: Other: Ultrasound Guided Intercostobrachial Nerve Block |
| Serratus Plane Block | Experimental | The patient will be placed in the lateral decubitus position with the area to be treated on the upper side. The high-frequency linear ultrasound probe and the region to be treated will be sterilized. The ultrasound probe will be placed on the anterior line at the level of fourth and fifth ribs. Images of the muscle's latissimus dorsi and serratus anterior, the ribs, and the pleura will be obtained. Subsequently, with the in-plane technique, an 80-mm block needle will be advanced between the latissimus dorsi and the serratus muscles planes in a caudal to the cranial direction. There is no blood or air in aspiration. After confirming the location of the needle with 2 mL of saline solution, (20 mL of bupivacaine 0.25%) will be administered between the two muscles. Receives: Other: Serratus Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients who needed local anesthetic supplementation
Number of patients who needed local anesthetic supplementation will be recorded.
Measured: Intraoperatively
Secondary outcomes (2)
Total amount of morphine consumption
Rescue analgesia of morphine will be given as 3 mg bolus if the visual analog scale (VAS) > 3 to be repeated after 30 min if pain persists until the VAS < 4. VAS will be assessed at 0, 2, 4, 8, 12 and 24 h postoperatively.
Measured: 24 hours postoperatively
Patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start13 Jul 2024
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intercostobrachial Nerve BlockStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Zakarea Wfa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500572
- Sponsor's protocol ID
- 36264PR77/5/24
- Status last verified
- Apr 2025
- First submitted
- 8 Jul 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided, Landmark Guided Intercostobrachial Nerve Block Versus Serratus Plane Block After Supraclavicular Plexus Block for Anesthesia in Creation of Arteriovenous Fistula in the Medial Side of the Arm: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06500572
- Acronym / sponsor ID
- 36264PR77/5/24
- Conditions
- Intercostobrachial Nerve Block, Serratus Plane Block, Supraclavicular Plexus Block, Arteriovenous Fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 13 Jul 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the role of ultrasound-guided and landmark-guided intercostobrachial nerve block and serratus plane block after supraclavicular plexus block for anesthesia in the creation of an arteriovenous fistula in the medial side of the arm.
Detailed description
Brachial plexus block (BPB) is usually utilized for proximal arm arteriovenous access creation. It has been suggested that supraclavicular brachial plexus block (SCPB) could be an alternative and provide comparable effective anesthesia and postoperative analgesia for arm surgery, with a reduced incidence of adverse events, including hemidiaphragmatic paresis.
By performing SCPB, the inner part of the arm is not completely anesthetized because this part of the arm is innervated by the lateral cutaneous branch of the second intercostal nerve (intercostobrachial nerve (ICBN)) and the medial branch of the brachial cutaneous nerve.
Serratus plane block (SPB) was first defined in 2013 by Blanco et al. This block provides anesthesia and analgesia in the hemi-thorax, where it is applied to block the thoracic intercostal nerves, in addition to the axillary region and shoulder posteriorly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Landmark Guided Intercostobrachial Nerve Block | Active comparator | Other: Landmark Guided Intercostobrachial Nerve BlockIn addition to the supraclavicular plexus block, the intercostobrachial nerve block block will be performed without ultrasound guidance and based on the traditional method using superficial anatomy and nerve pathway by subcutaneous injection of 20 mL of bupivacaine 0.25% at the site of the pulse. |
| Ultrasound Guided Intercostobrachial Nerve Block | Experimental | Other: Ultrasound Guided Intercostobrachial Nerve BlockThe patient's head will be turned to the opposite side while the patient is in the supine position and the shoulder to be treated will be elevated 5- 10 cm. The high-frequency linear ultrasound probe (12-4 MHz) and the region to be treated will be prepared in sterile conditions and placed transversely across the external jugular vein at 3-4 cm above the clavicle. Between the anterior and middle scalene muscles, the imaging of the brachial plexus showed three to five hypoechoic circles. The entry will be in-plane technique using an 80-mm block needle from lateral to medial. After confirming the needle insertion site with 2 mL saline solution, a 20 mL bupivacaine 0.25% will be administered. |
| Serratus Plane Block | Experimental | Other: Serratus Plane BlockThe patient will be placed in the lateral decubitus position with the area to be treated on the upper side. The high-frequency linear ultrasound probe and the region to be treated will be sterilized. The ultrasound probe will be placed on the anterior line at the level of fourth and fifth ribs. Images of the muscle's latissimus dorsi and serratus anterior, the ribs, and the pleura will be obtained. Subsequently, with the in-plane technique, an 80-mm block needle will be advanced between the latissimus dorsi and the serratus muscles planes in a caudal to the cranial direction. There is no blood or air in aspiration. After confirming the location of the needle with 2 mL of saline solution, (20 mL of bupivacaine 0.25%) will be administered between the two muscles. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Scheduled for creation of arteriovenous fistula in the medial side of the arm.
Key exclusion criteria (10 listed)
- Allergy to local anesthetics.
- Drug addiction.
- Coagulation abnormalities.
- Body Mass Index (BMI)≥35 kg/m2.
- Upper extremity neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Landmark Guided Intercostobrachial Nerve BlockIn addition to the supraclavicular plexus block, the intercostobrachial nerve block block will be performed without ultrasound guidance and based on the traditional method using superficial anatomy and nerve pathway by subcutaneous injection of 20 mL of bupivacaine 0.25% at the site of the pulse. | Other | Landmark Guided Intercostobrachial Nerve Block |
| Ultrasound Guided Intercostobrachial Nerve BlockThe patient's head will be turned to the opposite side while the patient is in the supine position and the shoulder to be treated will be elevated 5- 10 cm. The high-frequency linear ultrasound probe (12-4 MHz) and the region to be treated will be prepared in sterile conditions and placed transversely across the external jugular vein at 3-4 cm above the clavicle. Between the anterior and middle scalene muscles, the imaging of the brachial plexus showed three to five hypoechoic circles. The entry will be in-plane technique using an 80-mm block needle from lateral to medial. After confirming the needle insertion site with 2 mL saline solution, a 20 mL bupivacaine 0.25% will be administered. | Other | Ultrasound Guided Intercostobrachial Nerve Block |
| Serratus Plane BlockThe patient will be placed in the lateral decubitus position with the area to be treated on the upper side. The high-frequency linear ultrasound probe and the region to be treated will be sterilized. The ultrasound probe will be placed on the anterior line at the level of fourth and fifth ribs. Images of the muscle's latissimus dorsi and serratus anterior, the ribs, and the pleura will be obtained. Subsequently, with the in-plane technique, an 80-mm block needle will be advanced between the latissimus dorsi and the serratus muscles planes in a caudal to the cranial direction. There is no blood or air in aspiration. After confirming the location of the needle with 2 mL of saline solution, (20 mL of bupivacaine 0.25%) will be administered between the two muscles. | Other | Serratus Plane Block |
Primary outcome
Percent of patients who needed local anesthetic supplementation
Time frame: Intraoperatively
Number of patients who needed local anesthetic supplementation will be recorded.
2 secondary outcomes
Total amount of morphine consumption
Time frame: 24 hours postoperatively
Patient satisfaction
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Landmark Guided Intercostobrachial Nerve Block, Ultrasound Guided Intercostobrachial Nerve Block and Serratus Plane Block in people with Intercostobrachial Nerve Block and Serratus Plane Block, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients who needed local anesthetic supplementation (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.