Comparison Between Ultrasound-Guided Costoclavicular and Lateral-Sagittal Infraclavicular Brachial Plexus Blocks in Adult Distal Upper Limb Surgeries : A Randomized Controlled Trial

April 2, 2026 updated by: Ain Shams University
The aim of the study is to compare the onset time of the costoclavicular approach of brachial plexus block with that of the lateral-sagittal infraclavicular approach in adults distal upper limb surgeries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Regional anesthesia is commonly used for distal upper limb surgeries as it provides effective surgical anesthesia, reduces opioid consumption, and offers prolonged postoperative analgesia. Ultrasound-guided infraclavicular brachial plexus block is a well-established technique for these procedures. The traditional lateral-sagittal infraclavicular approach (LS-ICB) provides reliable anesthesia but may require multiple needle redirections to achieve adequate spread of local anesthetic around the cords of the brachial plexus. The costoclavicular (CC) approach is a newer ultrasound-guided infraclavicular technique in which the three cords of the brachial plexus are clustered together in the costoclavicular space, potentially allowing easier needle placement and faster spread of local anesthetic.

This prospective randomized controlled trial will include 50 adult patients undergoing distal upper limb surgery under regional anesthesia. Participants will be randomly assigned into two equal groups (25 patients each). Group CC will receive an ultrasound-guided costoclavicular brachial plexus block, while Group ICB will receive an ultrasound-guided lateral-sagittal infraclavicular brachial plexus block.

In both groups, the block will be performed using a mixture of 2% lidocaine and 0.5% bupivacaine in a 1:1 ratio with a total volume of 0.3 mL/kg, administered under real-time ultrasound guidance.

The primary outcome of the study is the time to onset of complete sensory and motor blockade after injection of the local anesthetic solution. Sensory block will be assessed using pinprick testing in the distributions of the median, ulnar, radial, and musculocutaneous nerves.

Secondary outcomes include block performance time, block success rate, incidence of complications (such as vascular puncture, pneumothorax, or local anesthetic systemic toxicity), postoperative pain scores, and total analgesic consumption during the first 24 hours after surgery. The findings of this study may help identify the most effective and safe infraclavicular block technique for distal upper limb surgeries.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Ain shams university hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA physical status I-III
  • Distal upper limb surgery requiring brachial plexus block.
  • Patient approval after written and informed consent to participate.

Exclusion Criteria:

  • Patient refusal.
  • Allergy to drugs used.
  • Infection at puncture site.
  • Coagulopathy or anticoagulant therapy.
  • Pre-existing neuropathy or neurological deficit in the affected limb.
  • Severe pulmonary disease.
  • BMI > 40 kg/m².

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Lateral-sagittal infraclavicular block (LS-ICB) group
Drug : A mixture of 2% lidocaine and 0.5% bupivacaine with volume of 0.3 mL/kg and a ratio of 1:1.
Procedure: Lateral-sagittal infraclavicular brachial plexus block
Ultrasound-guided lateral-sagittal infraclavicular brachial plexus block performed using a high-frequency linear probe. A mixture of 2% lidocaine and 0.5% bupivacaine (1:1 ratio) with a total volume of 0.3 mL/kg is injected around the cords of the brachial plexus under real-time ultrasound guidance.
Active Comparator: Costoclavicular block brachial plexus (CC) group
Procedure: Costoclavicular brachial plexus block
Ultrasound-guided costoclavicular brachial plexus block performed using a high-frequency linear probe. A mixture of 2% lidocaine and 0.5% bupivacaine (1:1 ratio) with a total volume of 0.3 mL/kg is injected in the costoclavicular space around the cords of the brachial plexus under real-time ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to onset of complete sensory and motor block
Time Frame: From completion of injection up to 30 minutes after block performance
Time from completion of local anesthetic injection to achievement of complete sensory and motor blockade. Sensory block will be assessed using pinprick testing in the distributions of the median, ulnar, radial, and musculocutaneous nerves. Motor block will be graded using a standardized motor scale. And time will be in minutes and seconds.
From completion of injection up to 30 minutes after block performance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FMASU MS 101/2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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