NCT07386470

Brief Summary

This randomized clinical study aims to compare the effects of two different ultrasound-guided infraclavicular brachial plexus block techniques-costoclavicular and lateral sagittal approaches-in patients undergoing forearm, wrist, or hand surgery. The primary objective of the study is to evaluate and compare the incidence of hemidiaphragmatic dysfunction associated with these two block techniques. Secondary outcomes include sensory and motor block characteristics, postoperative pain scores, analgesic requirements, and potential block-related complications. Eligible adult patients scheduled for elective forearm or hand surgery are randomly assigned to receive either a costoclavicular or a lateral sagittal infraclavicular nerve block using bupivacaine under ultrasound guidance. Standard general anesthesia and postoperative analgesia protocols are applied. The results of this study are expected to provide evidence on the relative safety and efficacy of these two infraclavicular block approaches, particularly regarding diaphragmatic function, and to help guide anesthesiologists in selecting the most appropriate regional anesthesia technique for upper extremity surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 28, 2026

Last Update Submit

February 3, 2026

Conditions

Keywords

Infraclavicular brachial plexus blockhemidiaphragmatic paralysiscostoclavicular brachial plexus block

Outcome Measures

Primary Outcomes (1)

  • Diaphragmatic excursion

    Diaphragmatic excursion measured by ultrasound during normal and deep breathing to asses the effect of costoclavicular and lateral sagittal infraclavicular block techniques.

    Baseline(pre-block) and 30 minutes after block performance.

Secondary Outcomes (2)

  • Sensory and motor block onset time

    Within the first 30 minutes after block performance.

  • Time to first postoperative analgesic requirement

    Within the first 24 hours postoperatively.

Study Arms (2)

Costoclavicular infraclavicular block

EXPERIMENTAL

Ultrasound-guided costoclavicular infraclavicular brachial plexus block

Procedure: Ultrasound-guided Infraclavicular block

Lateral sagittal infraclavicular block

ACTIVE COMPARATOR

Ultrasound-guided lateral sagittal infraclavicular brachial plexus block

Procedure: Ultrasound-guided Infraclavicular block

Interventions

Ultrasound-guided infraclavicular brachial plexus block performed using either the costoclavicular or lateral sagittal approach with standardized local anesthetic volume.

Also known as: costoclavicular infraclavicular block, lateral sagital infraclavicular block
Costoclavicular infraclavicular blockLateral sagittal infraclavicular block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-80 years
  • ASA physical status I-III
  • Scheduled for forearm, wrist, or hand surgery
  • Planned infraclavicular brachial plexus block

You may not qualify if:

  • Refusal of regional anesthesia
  • Known allergy to local anesthetics
  • Infection at the block site
  • Pre-existing neurological deficit in the operative limb
  • Severe pulmonary disease
  • Coagulopathy or sepsis
  • BMI \> 40 kg/m²
  • Psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Medicine, Department of Anesthesiology and Reanimation

Ankara, Ankara, 06560, Turkey (Türkiye)

Location

Study Officials

  • Irfan Güngör, MD

    Gazi University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This was a prospective, randomized, parallel group study comparing two ultrasound guided infraclavicular block techniques
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 4, 2026

Study Start

October 15, 2022

Primary Completion

April 15, 2023

Study Completion

April 15, 2023

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations