NCT07852351

Brief Summary

The present clinical study will be undertaken to evaluate and compare the clinical efficacy of two different volumes of distal ICBN block when combined with a baseline supraclavicular brachial plexus block during superficialization of upper arm arteriovenous fistula

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Oct 2026

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

Study Progress1%
Oct 2026Mar 2028

First Submitted

Initial submission to the registry

September 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1.2 years

First QC Date

September 24, 2026

Last Update Submit

September 30, 2026

Conditions

Keywords

esrdSupraclavicular Plexus Block Procedure (SCPB)

Outcome Measures

Primary Outcomes (1)

  • Comparing the incidence of successful complete sensory block

    successful complete sensory block between the two techniques at 30 minutes after injection using cold sensitivity test.

    baseline

Study Arms (2)

Supraclavicular Plexus Block Procedure (SCPB)

EXPERIMENTAL
Procedure: Supraclavicular Plexus Block Procedure (SCPB)

Distal Intercostobrachial Nerve Block

EXPERIMENTAL
Procedure: Distal Intercostobrachial Nerve Block

Interventions

Ultrasound Positioning and Administration: The transducer will be placed transversely across the inner aspect of the arm, directly beneath where the pectoralis major muscle attaches. Infiltration Technique: Probe transversely across the axillary fold/proximal medial arm. Identify pectoralis major anteriorly and latissimus dorsi posteriorly. The target is the subcutaneous plane superficial to the brachial fascia, spanning between these muscular boundaries. Patients will be divided into two equal groups. Group H will be injected with 12 milliliters of bupivacaine 0.25%, and Group L will be injected with 6 milliliters of bupivacaine 0.25%, while advancing the needle so the LA forms a continuous subcutaneous spread from the pectoralis major side toward the latissimus dorsi side

Distal Intercostobrachial Nerve Block

supine with the head turned approximately 30° away from the surgical side, and a small towel will be positioned between the scapulae to optimize access. After aseptic preparation, a high-frequency linear US probe (6 - 12 MHz) covered with a sterile sheath will be 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. Using an in-plane lateral-to-medial approach, a 22-G, 80-mm insulated block needle will be 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, Ten mL of bupivacaine 0.3% will be injected into the corner pocket. needle will be redirected to deposit additional 3 - 5 mL

Supraclavicular Plexus Block Procedure (SCPB)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients aged 18 to 65 years of either sex
  • Patients scheduled for elective upper-arm AVF superficialization (brachiobasilic or brachiocephalic)
  • ASA physical status II, III (common in chronic kidney disease patients)

You may not qualify if:

  • Pre-existing peripheral neuropathy or severe neurological deficits in the operative upper extremity.
  • Cognitive impairment, psychiatric disorders, or an inability to comprehend and communicate the pain scoring scales
  • Patients on chronic opioid use
  • Local infection, severe dermatitis, or anatomical distortions at the proposed needle insertion sites.
  • Known allergy or hypersensitivity to local anesthetics.
  • Patient refusal of regional anesthesia techniques.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 24, 2026

First Posted

October 1, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

October 1, 2026

Record last verified: 2026-09