NCT07823738

Brief 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. 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).

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

11 months

First QC Date

September 9, 2026

Last Update Submit

September 16, 2026

Conditions

Nerve BlockRegional AnesthesiaUpper Extremity Surgery

Keywords

axillary blockinterfascial blockregional anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

    30 minutes after block

Secondary Outcomes (5)

  • Block application time

    intraoperative

  • Sensory block onset time

    5., 10., 15., 30. minutes

  • Motor block onset time

    5., 10., 15., 30. minutes

  • Intraoperative additional analgesic/sedation consumption

    intraoperative

  • Patient and surgeon satisfaction

    2nd day after surgery

Study Arms (2)

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.

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.

Procedure: Interfascial Axillary Block

Interventions

Classic Axillary BlockPROCEDURE

Classic (perivascular/perineural) axillary brachial plexus block

Classic Axillary Block
Interfascial Axillary BlockPROCEDURE

Interfascial (fascial-plane) axillary brachial plexus block.

Interfascial Axillary Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, Turkey (Türkiye)

Location

Central Study Contacts

Korgün Ökmen, PhD.

CONTACT

05057081021korgunokmen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator.PhD.MD

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 16, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

September 21, 2026

Record last verified: 2026-09

Locations

TU(1)