Nerve BlockNCT07823738
Classic Versus Interfascial Axillary Block in Hand, Wrist, and Forearm Surgery
A study testing Classic Axillary Block and Interfascial Axillary Block in people with Nerve Block and Regional Anesthesia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Hand, wrist, and forearm surgeries are commonly performed procedures with significant postoperative pain potential. Regional anesthesia of the brachial plexus via the axillary approach is one of the gold-standard techniques for distal upper-limb surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nerve Block, Regional Anesthesia, Upper Extremity Surgery
- What is being tested?
- Classic Axillary Block and Interfascial Axillary Block
- 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 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18-90 years
- American society of anesthesiologists physical status I-II-III
- Scheduled for elective hand, wrist, or forearm surgery
- Written informed consent obtained
Who cannot join
- History of local anesthetic allergy
- Coagulation disorder
- BMI > 40 kg/m²
- Infection at the block site
- Chronic pain syndrome
- Pregnancy
- Inability to communicate
- Need for emergency surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110
About this study
Official title: Comparison of Axillary Block and Interfascial Axillary Block in Terms of Block Success and Intraoperative Clinical Efficacy in Hand, Wrist, and Forearm Surgery: A Prospective Randomized Study
Hand, wrist, and forearm surgeries are commonly performed procedures with significant postoperative pain potential. Regional anesthesia of the brachial plexus via the axillary approach is one of the gold-standard techniques for distal upper-limb surgery. In the conventional (classic) axillary block, the median, ulnar, and radial nerves within the axillary sheath are individually targeted under ultrasound guidance; however, anatomical septations around the axillary artery may prevent homogeneous spread of local anesthetic, leading to a patchy block and reduced intraoperative success.
The interfascial axillary block is a modified approach in which local anesthetic is deposited into the fascial planes between the axillary muscles rather than directly into the nerve sheath, aiming for passive diffusion, homogeneous spread, and fewer needle manipulations. This prospective, randomized, single-center study compares the classic axillary block with the interfascial axillary block in patients undergoing hand, wrist, and forearm surgery, primarily in terms of surgical anesthesia adequacy (block success).
Read the detailed description
This is a prospective, randomized, single-center clinical trial conducted in a Department of Anesthesiology and Reanimation. Randomization is performed using the sealed-envelope method. A total of 110 patients (55 per group) aged 18-90 years, American society of anesthesiologists physical status I-III, scheduled for elective hand, wrist, or forearm surgery under ultrasound-guided regional anesthesia will be enrolled.
Group 1 (Classic Axillary Block) receives an ultrasound-guided block targeting the median, ulnar, and radial nerves perineurally/perivascularly within the axillary sheath. Group 2 (Interfascial Axillary Block) receives an ultrasound-guided injection of local anesthetic into the potential fascial planes between the axillary muscles, relying on passive diffusion.
The primary outcome is surgical anesthesia adequacy (block success). Secondary outcomes include block application time, sensory and motor block onset, rates of additional local infiltration and conversion to general anesthesia, intraoperative additional analgesic/sedation requirements, hemodynamic parameters, patient and surgeon satisfaction, and complications.
- Conditions
- Nerve Block, Regional Anesthesia, Upper Extremity Surgery
- Being tested
- Classic Axillary Block, Interfascial Axillary Block
- Keywords
- axillary block, interfascial block, regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Classic Axillary BlockProcedure or surgery
Classic (perivascular/perineural) axillary brachial plexus block
Interfascial Axillary BlockProcedure or surgery
Interfascial (fascial-plane) axillary brachial plexus block.
| Study group | Role | What they receive |
|---|---|---|
| Classic Axillary Block | Active comparator | Ultrasound-guided classic axillary brachial plexus block. The median, ulnar, and radial nerves within the axillary sheath around the axillary artery are targeted individually by perineural/perivascular injection of local anesthetic. Receives: Procedure: Classic Axillary Block |
| Interfascial Axillary Block | Active comparator | Ultrasound-guided interfascial axillary block. Local anesthetic is injected into the potential fascial planes between the axillary muscles rather than directly into the nerve sheath, allowing passive diffusion of the drug. Receives: Procedure: Interfascial Axillary Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical anesthesia adequacy (block success)
Complete sensory and motor blockade of the surgical field, allowing the operation to be completed without additional local infiltration or conversion to general anesthesia
Measured: 30 minutes after block
Secondary outcomes (5)
Block application time
time from needle insertion to withdrawal.
Measured: intraoperative
Sensory block onset time
Pin-Prick test in the median, ulnar, radial, and musculocutaneous dermatomes (0: normal, 1: blunt, 2: no sensation).
Measured: 5., 10., 15., 30. minutes
Motor block onset time
Measured: 5., 10., 15., 30. minutes
Intraoperative additional analgesic/sedation consumption
Measured: intraoperative
Patient and surgeon satisfaction
4-point Likert scale (1: very poor, 4: very good)
Measured: 2nd day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07823738
- Sponsor's protocol ID
- BursaYIEAH-2026-1
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Axillary Block and Interfascial Axillary Block in Terms of Block Success and Intraoperative Clinical Efficacy in Hand, Wrist, and Forearm Surgery: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07823738
- Acronym / sponsor ID
- BursaYIEAH-2026-1
- Conditions
- Nerve Block, Regional Anesthesia, Upper Extremity Surgery
- Keywords
- axillary block, interfascial block, regional anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 16 Sep 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.
Hand, wrist, and forearm surgeries are commonly performed procedures with significant postoperative pain potential. Regional anesthesia of the brachial plexus via the axillary approach is one of the gold-standard techniques for distal upper-limb surgery. In the conventional (classic) axillary block, the median, ulnar, and radial nerves within the axillary sheath are individually targeted under ultrasound guidance; however, anatomical septations around the axillary artery may prevent homogeneous spread of local anesthetic, leading to a patchy block and reduced intraoperative success.
The interfascial axillary block is a modified approach in which local anesthetic is deposited into the fascial planes between the axillary muscles rather than directly into the nerve sheath, aiming for passive diffusion, homogeneous spread, and fewer needle manipulations. This prospective, randomized, single-center study compares the classic axillary block with the interfascial axillary block in patients undergoing hand, wrist, and forearm surgery, primarily in terms of surgical anesthesia adequacy (block success).
Detailed description
This is a prospective, randomized, single-center clinical trial conducted in a Department of Anesthesiology and Reanimation. Randomization is performed using the sealed-envelope method. A total of 110 patients (55 per group) aged 18-90 years, American society of anesthesiologists physical status I-III, scheduled for elective hand, wrist, or forearm surgery under ultrasound-guided regional anesthesia will be enrolled.
Group 1 (Classic Axillary Block) receives an ultrasound-guided block targeting the median, ulnar, and radial nerves perineurally/perivascularly within the axillary sheath. Group 2 (Interfascial Axillary Block) receives an ultrasound-guided injection of local anesthetic into the potential fascial planes between the axillary muscles, relying on passive diffusion.
The primary outcome is surgical anesthesia adequacy (block success). Secondary outcomes include block application time, sensory and motor block onset, rates of additional local infiltration and conversion to general anesthesia, intraoperative additional analgesic/sedation requirements, hemodynamic parameters, patient and surgeon satisfaction, and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic Axillary Block | Active comparator | Procedure: Classic Axillary BlockUltrasound-guided classic axillary brachial plexus block. The median, ulnar, and radial nerves within the axillary sheath around the axillary artery are targeted individually by perineural/perivascular injection of local anesthetic. |
| Interfascial Axillary Block | Active comparator | Procedure: Interfascial Axillary BlockUltrasound-guided interfascial axillary block. Local anesthetic is injected into the potential fascial planes between the axillary muscles rather than directly into the nerve sheath, allowing passive diffusion of the drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-90 years
- American society of anesthesiologists physical status I-II-III
- Scheduled for elective hand, wrist, or forearm surgery
- Written informed consent obtained
Key exclusion criteria (8 listed)
- History of local anesthetic allergy
- Coagulation disorder
- BMI > 40 kg/m²
- Infection at the block site
- Chronic pain syndrome
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 |
|---|---|---|
| Classic Axillary BlockClassic (perivascular/perineural) axillary brachial plexus block | Procedure or surgery | Classic Axillary Block |
| Interfascial Axillary BlockInterfascial (fascial-plane) axillary brachial plexus block. | Procedure or surgery | Interfascial Axillary Block |
Primary outcome
Surgical anesthesia adequacy (block success)
Time frame: 30 minutes after block
Complete sensory and motor blockade of the surgical field, allowing the operation to be completed without additional local infiltration or conversion to general anesthesia
5 secondary outcomes
Block application time
Time frame: intraoperative
Sensory block onset time
Time frame: 5., 10., 15., 30. minutes
Motor block onset time
Time frame: 5., 10., 15., 30. minutes
Intraoperative additional analgesic/sedation consumption
Time frame: intraoperative
Patient and surgeon satisfaction
Time frame: 2nd day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Classic Axillary Block and Interfascial Axillary Block in people with Nerve Block and Regional Anesthesia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 8 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: opening soon, as of the sponsor's last update on 21 Sep 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Korgün Ökmen, PhD. (05057081021, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical anesthesia adequacy (block success) (time frame: 30 minutes after block). 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 21 Sep 2026.