- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07386470
Comparison of Costoclavicular and Lateral Sagittal Infraclavicular Blocks (CCLS-ICB)
Effect of Costoclavicular Versus Lateral Sagittal Infraclavicular Block on Hemidiaphragmatic Function: A Randomized Clinical Study
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Ankara, Ankara, Turkey (Türkiye), 06560
- Gazi University Faculty of Medicine, Department of Anesthesiology and Reanimation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-80 years
- ASA physical status I-III
- Scheduled for forearm, wrist, or hand surgery
- Planned infraclavicular brachial plexus block
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Costoclavicular infraclavicular block
Ultrasound-guided costoclavicular infraclavicular brachial plexus block
|
Ultrasound-guided infraclavicular brachial plexus block performed using either the costoclavicular or lateral sagittal approach with standardized local anesthetic volume.
Other Names:
|
|
Active Comparator: Lateral sagittal infraclavicular block
Ultrasound-guided lateral sagittal infraclavicular brachial plexus block
|
Ultrasound-guided infraclavicular brachial plexus block performed using either the costoclavicular or lateral sagittal approach with standardized local anesthetic volume.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diaphragmatic excursion
Time Frame: Baseline(pre-block) and 30 minutes after block performance.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensory and motor block onset time
Time Frame: Within the first 30 minutes after block performance.
|
Time from completion of the infraclavicular block to achievement of complete sensory and motor block in the radial, median, ulnar, and musculocutaneous nerve distributions.
Sensory and motor function were assessed every 5 minutes for up to 30 minutes after block performance, and block onset time was defined as the time to complete block.
|
Within the first 30 minutes after block performance.
|
|
Time to first postoperative analgesic requirement
Time Frame: Within the first 24 hours postoperatively.
|
Time from the end of the surgery to the first analgesic requirement.
|
Within the first 24 hours postoperatively.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Irfan Güngör, MD, Gazi University Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ICB-CC-LS-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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