ESRD (End Stage Renal Disease)ICBN/ESPNCT07754357
Ultrasound-Guided T2 Erector Spinae Plane Block Versus Intercostobrachial Block in AV Fistula Surgery.
A study testing Ultrasound Guided Intercostobrachial Nerve Block and Ultrasound Guided Erector Spinae Plane Block at T2 level in people with ESRD (End Stage Renal Disease), run by Fatma Hatem Mokhtar at 1 site in Egypt.
Trial summary
This study aims to determine whether ultrasound guided ESP block at 2nd thoracic vertebrae is non inferior to ultrasound guided ICBN block as adjunct to supraclavicular brachial plexus block in achieving complete sensory blockade of the medial upper arm during AVF superficialization Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ESRD (End Stage Renal Disease)
- What is being tested?
- Ultrasound Guided Intercostobrachial Nerve Block and Ultrasound Guided Erector Spinae Plane Block at T2 level
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jul 2026to 24 Oct 2026
- 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
- • Adults scheduled for upper extremity surgeries under regional anesthesia.
- Age: 18-65 years.
- American society of Anesthesiologists (ASA) III.
- Body Mass Index (BMI) < 35 kg/m².
Who cannot join
- •Allergy to local anesthetics.
- Coagulopathy or infection at injection sites.
- Pre-existing neuropathy or significant psychiatric disorders.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided T2 Erector Spinae Plane Block Versus Intercostobrachial Block as Adjunct to Supraclavicular Brachial Plexus Block in AV Fistula Surgery.
This study aims to determine whether ultrasound guided ESP block at 2nd thoracic vertebrae is non inferior to ultrasound guided ICBN block as adjunct to supraclavicular brachial plexus block in achieving complete sensory blockade of the medial upper arm during AVF superficialization
Read the detailed description
Arteriovenous fistula (AVF) superficialization is an essential procedure for patients with end-stage renal disease . The supraclavicular brachial plexus block is commonly used for upper extremity surgeries .Because the ICBN originates from the T2 nerve root below the C5-T1 nerve roots comprising the brachial plexus, brachial plexus blocks are ideally supplemented with an ICBN infiltration block for medial upper arm coverage.The ICBB requires precise ultrasound guidance to target the ICBN, which is small and variably located, making it technically challenging and time-intensive.
ESP block at T2 level can provide broad coverage, ease of Performance, superficial injection and requiring less technical expertise compared to the ICBB .
The patients are randomly allocated into 2 groups :
- Erector spinae plane block group (Group ESP): will receive 10 ml of 0.5% bupivacaine injected into the erector spinae plane at T2 level under ultrasound guidance.
- Intercostobrachial block group (Group ICBB): will receive 10 ml of 0.5% bupivacaine injected around intercostobrachial nerve under ultrasound guidance. • Standard Supraclavicular Brachial plexus Block will be performed for all patients using 20 ml of 0.5% bupivacaine under ultrasound guidance.
- Conditions
- ESRD (End Stage Renal Disease)
- Being tested
- Ultrasound Guided Intercostobrachial Nerve Block, Ultrasound Guided Erector Spinae Plane Block at T2 level
- Keywords
- AVF superficialization, Intercostobrachial block
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Intercostobrachial Nerve BlockProcedure or surgery
Also called ICBB
- Position: patient supine with arm abducted.
- Ultrasound setup: High frequency probe positioned at upper axillary region.
- Technique: Needle will be advanced into subcutaneous tissue, in-plane to target intercostobrachial nerve near axillary artery.
- Drug: 10 ml of 0.5% bupivacaine.
Ultrasound Guided Erector Spinae Plane Block at T2 levelProcedure or surgery
- Position: patient sitting or in lateral decubitus.
- Ultrasound setup: High frequency linear transducer will be placed in a parasagittal 2-3 cm lateral to spinous process at T2 level, erector spinae muscles will be identified superficial to the tip of T2 transverse process, patient's skin anesthetized with 3 ml of 2 % lidocaine subcutaneously, the tip of the 22- gauge 80-mm block needle(Sonoplex, Pajunk Medical, Geisingen, Germany) needle will be placed into the facial plane on the deep (anterior) aspect of erector spinae muscle. location of needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process then 10 ml of 0.5% bupivacaine will be injected into the facial plane that will be confirmed by visible hydrodissection .
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Intercostobrachial Nerve Block | Active comparator | 1. Position: patient supine with arm abducted.
2. Ultrasound setup: High frequency probe positioned at upper axillary region.
3. Technique: Needle will be advanced into subcutaneous tissue, in-plane to target intercostobrachial nerve near axillary artery.
4. Drug: 10 ml of 0.5% bupivacaine. Receives: Procedure: Ultrasound Guided Intercostobrachial Nerve Block |
| Ultrasound Guided Erector Spinae Plane Block at T2 level | Active comparator | 1. Position: patient sitting or in lateral decubitus.
2. Ultrasound setup: High frequency linear transducer will be placed in a parasagittal 2-3 cm lateral to spinous process at T2 level, erector spinae muscles will be identified superficial to the tip of T2 transverse process, patient's skin anesthetized with 3 ml of 2 % lidocaine subcutaneously, the tip of the 22- gauge 80-mm block needle (Sonoplex, Pajunk Medical, Geisingen, Germany) needle will be placed into the facial plane on the deep (anterior) aspect of erector spinae muscle. location of needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process then 10 ml of 0.5% bupivacaine will be injected into the facial plane that will be confirmed by visible hydrodissection . Receives: Procedure: Ultrasound Guided Erector Spinae Plane Block at T2 level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving complete sensory blockade within 30 minutes without conversion to general anesthesia, irrespective of rescue sedation.
Complete sensory blockade was assessed 30 minutes after completion of the block procedure. Success was defined as achievement of adequate sensory blockade without conversion to general anesthesia, irrespective of rescue sedation. The outcome was recorded as the number and proportion of participants meeting all success criteria in each treatment group.
Measured: 30 minutes after completion of the block procedure
Secondary outcomes (5)
Time to achieve complete sensory blockade.
Time, in minutes, from completion of block placement to achievement of complete sensory blockade, as assessed by the study's sensory-testing procedure.
Measured: From completion of block placement until complete sensory blockade is achieved, assessed up to 30 minutes.
Patient's satisfaction (assessed using Likert scale).
Patient satisfaction assessed using the 5-point Likert scale and the EVAN-LR perioperative satisfaction questionnaire, as specified in the study protocol. The scoring range, interpretation of higher scores, and whether both measures were analyzed separately should be explicitly stated.
Measured: At 24 hours; the postoperative assessment.
Total opioid consumption in 24 hours
Total opioid consumption in 24 hours postoperative in mg /kg
Measured: in the first 24 hours
The visual analog scale(VAS)
measure a patient pain intensty ,commonly used interpretation is 0:no pain,1-3 :mild pain.4-6:moderate pain,7-10 :sever pain
Measured: in the first 12 hours
the proportion of participants achieving complete sensory blockade within 30 minutes, without discomfort requiring rescue sedation and without conversion to general anesthesia.
the proportion of participants achieving complete sensory blockade within 30 minutes, without discomfort requiring rescue sedation and without conversion to general anesthesia.
Measured: 30 minutes after completion of the block procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start29 Jul 2026
- Primary completion23 Oct 2026
- Study completion24 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRD (End Stage Renal Disease)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatma Hatem Mokhtar
- Sponsor type
- University, hospital or other
- Collaborators
- Aswan University Hospital
- Responsible party
- Sponsor-investigator, Fatma Hatem Mokhtar, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754357
- Sponsor's protocol ID
- 1118/6/25
- Acronym
- ICBN/ESP
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided T2 Erector Spinae Plane Block Versus Intercostobrachial Block as Adjunct to Supraclavicular Brachial Plexus Block in AV Fistula Surgery.
- ClinicalTrials.gov ID
- NCT07754357
- Acronym / sponsor ID
- ICBN/ESP / 1118/6/25
- Conditions
- ESRD (End Stage Renal Disease)
- Keywords
- AVF superficialization, Intercostobrachial block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Fatma Hatem MokhtarUniversity, hospital or other
- Collaborators
- Aswan University Hospital
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 23 Oct 2026 (actual)
- Study completion
- 24 Oct 2026 (actual)
- First posted
- 10 Aug 2026 (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 determine whether ultrasound guided ESP block at 2nd thoracic vertebrae is non inferior to ultrasound guided ICBN block as adjunct to supraclavicular brachial plexus block in achieving complete sensory blockade of the medial upper arm during AVF superficialization
Detailed description
Arteriovenous fistula (AVF) superficialization is an essential procedure for patients with end-stage renal disease . The supraclavicular brachial plexus block is commonly used for upper extremity surgeries .Because the ICBN originates from the T2 nerve root below the C5-T1 nerve roots comprising the brachial plexus, brachial plexus blocks are ideally supplemented with an ICBN infiltration block for medial upper arm coverage.The ICBB requires precise ultrasound guidance to target the ICBN, which is small and variably located, making it technically challenging and time-intensive.
ESP block at T2 level can provide broad coverage, ease of Performance, superficial injection and requiring less technical expertise compared to the ICBB .
The patients are randomly allocated into 2 groups :
- Erector spinae plane block group (Group ESP): will receive 10 ml of 0.5% bupivacaine injected into the erector spinae plane at T2 level under ultrasound guidance.
- Intercostobrachial block group (Group ICBB): will receive 10 ml of 0.5% bupivacaine injected around intercostobrachial nerve under ultrasound guidance. • Standard Supraclavicular Brachial plexus Block will be performed for all patients using 20 ml of 0.5% bupivacaine under ultrasound guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Intercostobrachial Nerve Block | Active comparator | Procedure: Ultrasound Guided Intercostobrachial Nerve Block1. Position: patient supine with arm abducted. 2. Ultrasound setup: High frequency probe positioned at upper axillary region. 3. Technique: Needle will be advanced into subcutaneous tissue, in-plane to target intercostobrachial nerve near axillary artery. 4. Drug: 10 ml of 0.5% bupivacaine. |
| Ultrasound Guided Erector Spinae Plane Block at T2 level | Active comparator | Procedure: Ultrasound Guided Erector Spinae Plane Block at T2 level1. Position: patient sitting or in lateral decubitus. 2. Ultrasound setup: High frequency linear transducer will be placed in a parasagittal 2-3 cm lateral to spinous process at T2 level, erector spinae muscles will be identified superficial to the tip of T2 transverse process, patient's skin anesthetized with 3 ml of 2 % lidocaine subcutaneously, the tip of the 22- gauge 80-mm block needle (Sonoplex, Pajunk Medical, Geisingen, Germany) needle will be placed into the facial plane on the deep (anterior) aspect of erector spinae muscle. location of needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process then 10 ml of 0.5% bupivacaine will be injected into the facial plane that will be confirmed by visible hydrodissection . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Adults scheduled for upper extremity surgeries under regional anesthesia.
Key exclusion criteria (4 listed)
- •Allergy to local anesthetics.
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 |
|---|---|---|
| Ultrasound Guided Intercostobrachial Nerve BlockAlso: ICBB1. Position: patient supine with arm abducted. 2. Ultrasound setup: High frequency probe positioned at upper axillary region. 3. Technique: Needle will be advanced into subcutaneous tissue, in-plane to target intercostobrachial nerve near axillary artery. 4. Drug: 10 ml of 0.5% bupivacaine. | Procedure or surgery | Ultrasound Guided Intercostobrachial Nerve Block |
| Ultrasound Guided Erector Spinae Plane Block at T2 level1. Position: patient sitting or in lateral decubitus. 2. Ultrasound setup: High frequency linear transducer will be placed in a parasagittal 2-3 cm lateral to spinous process at T2 level, erector spinae muscles will be identified superficial to the tip of T2 transverse process, patient's skin anesthetized with 3 ml of 2 % lidocaine subcutaneously, the tip of the 22- gauge 80-mm block needle(Sonoplex, Pajunk Medical, Geisingen, Germany) needle will be placed into the facial plane on the deep (anterior) aspect of erector spinae muscle. location of needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process then 10 ml of 0.5% bupivacaine will be injected into the facial plane that will be confirmed by visible hydrodissection . | Procedure or surgery | Ultrasound Guided Erector Spinae Plane Block at T2 level |
Primary outcome
Proportion of Participants Achieving complete sensory blockade within 30 minutes without conversion to general anesthesia, irrespective of rescue sedation.
Time frame: 30 minutes after completion of the block procedure
Complete sensory blockade was assessed 30 minutes after completion of the block procedure. Success was defined as achievement of adequate sensory blockade without conversion to general anesthesia, irrespective of rescue sedation. The outcome was recorded as the number and proportion of participants meeting all success criteria in each treatment group.
5 secondary outcomes
Time to achieve complete sensory blockade.
Time frame: From completion of block placement until complete sensory blockade is achieved, assessed up to 30 minutes.
Patient's satisfaction (assessed using Likert scale).
Time frame: At 24 hours; the postoperative assessment.
Total opioid consumption in 24 hours
Time frame: in the first 24 hours
The visual analog scale(VAS)
Time frame: in the first 12 hours
the proportion of participants achieving complete sensory blockade within 30 minutes, without discomfort requiring rescue sedation and without conversion to general anesthesia.
Time frame: 30 minutes after completion of the block procedure
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 28 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 Ultrasound Guided Intercostobrachial Nerve Block and Ultrasound Guided Erector Spinae Plane Block at T2 level in people with ESRD (End Stage Renal Disease), run by Fatma Hatem Mokhtar 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 4 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 28 Oct 2026. 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?
Proportion of Participants Achieving complete sensory blockade within 30 minutes without conversion to general anesthesia, irrespective of rescue sedation. (time frame: 30 minutes after completion of the block procedure). 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 28 Oct 2026.