AnesthesiaNCT05260736
Comparison of Costoclavicular and Paracoracoid Approaches to Infraclavicular Brachial Plexus Blocks
A study testing Infraclavicular brachial plexus block in people with Anesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Infraclavicular block has taken its place in the literature as a proven technique in the anesthetic management of upper extremity surgeries. Compared to general anesthesia; The prominent advantages of regional anesthesia are that it provides longer perioperative pain control, reduces the incidence of postoperative… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Infraclavicular brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 2 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective upper extremity surgeries (Arm, upper-arm and hand)
Who cannot join
- Patients with bleeding diathesis Presence of infection on the intervention site Patients requiring continous anticoagulation therapy due to the existing comorbidities Patients with history of local anesthetic allergy Pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Meltem Savran Karadeniz
Istanbul, Fatih, 34000
About this study
Official title: Comparison of Costoclavicular Lateral, Costoclavicular Medial and Lateral Sagittal Approaches to Infraclavicular Brachial Plexus Block in Upper Extremity Surgery
Infraclavicular block has taken its place in the literature as a proven technique in the anesthetic management of upper extremity surgeries. Compared to general anesthesia; The prominent advantages of regional anesthesia are that it provides longer perioperative pain control, reduces the incidence of postoperative nausea and vomiting, reduces opioid consumption and reduces the cost of hospitalization. The widespread use of ultrasonography (USG) in the last two decades has facilitated the application of the method and allowed the investigation of different injection methods.
Regional blocks are planned according to the surgery to be performed. For anesthesia of arm, forearm and hand operations; brachial plexus can be blocked in the axillary, infraclavicular, supraclavicular or interscalene region. The infraclavicular technique, on the other hand, is roughly divided into three types: costoclavicular lateral, costoclavicular medial and paracoracoid (Lateral sagittal). The image obtained by placing the ultrasonography probe in the relevant anatomical region serves as a guide for the orientation of the peripheral block needle and performing the intervention by observing the vascular structures in the existing region provides a great advantage in terms of patient safety.
In this study, we aimed to examine 3 different infraclavicular block methods; lateral costoclavicular, medial costoclavicular and lateral sagittal (Paracoracoid) approach, in terms of ease of application and motor/sensory block efficiency. Our hypothesis is that the sensory block will begin in a shorter time with costoclavicular methods compared to the lateral sagittal method. We are also planning to compare performance difficulties (needle maneuver numbers, subjective block exertion, block performance time etc.) for each type of intervention.
- Conditions
- Anesthesia
- Being tested
- Infraclavicular brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular brachial plexus blockProcedure or surgery
Named after the anatomical site; patients will be applied infraclavicular brachial plexus block with costoclavicular lateral, costoclavicular medial or lateral sagittal approach.
| Study group | Role | What they receive |
|---|---|---|
| Group Costoclavicular Lateral (CL) | Active comparator | Patients anesthetized with costoclavicular lateral infraclavicular brachial plexus block. Receives: Procedure: Infraclavicular brachial plexus block |
| Group Costoclavicular Medial (CM) | Active comparator | Patients anesthetized with costoclavicular medial infraclavicular brachial plexus block. Receives: Procedure: Infraclavicular brachial plexus block |
| Group Lateral Sagittal (LS) | Active comparator | Patients anesthetized with lateral sagittal infraclavicular brachial plexus block. Receives: Procedure: Infraclavicular brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory block onset time
Separately evaluated sensorial examination for four nerves (n. medianus, n. radialis, n. ulnaris, n. musculocutaneus), a total number of 6 points is accepted as "settled sensory block". 0= absent sensory block (feels pain), 1= partial sensory block (feels touch), 2= complete sensory block (no sense). Patients will be evaluated every 5 minutes after intervention.
Measured: Up to 45 minutes.
Secondary outcomes (11)
Ideal USG guided brachial plexus cords visualization / needle pathway planning time
Practitioner's ideal image acquisition time
Measured: Up to 15 minutes
Needle tip and shaft imaging visualization difficulty
Likert Scale: 1-5 (1:very hard; 5: very easy)
Measured: Up to 15 minutes
Requirement of additional maneuver due to insufficient local anesthetic distribution
Extra needle redirection to cover neural structure
Measured: Up to 15 minutes
Total procedure difficulty according to anesthesiologist
Likert Scale: 1-5 (1:Very hard; 5: Very easy)
Measured: Up to 15 minutes
Patient number requiring rescue analgesics
If a ≥ 20% increase above preinduction values in MAP or HR was observed during the perioperative period, additional fentanyl dose (1 μg/kg) was applied intravenously
Measured: Intraoperative 2-4 hours
Motor blockade onset time
Separately evaluated motor examination for four nerves (n. medianus, n. radialis, n. ulnaris, n. musculocutaneus), a total number of 6 points is accepted as "settled motor block". 0= absent motor block (Full movement), 1= partial motor block (free movement only), 2= complete motor block (no movement). Patients will be evaluated every 5 minutes after intervention.
Measured: Up to 45 minutes
Time to postoperative first pain
Time to first intravenous analgesic administration which is requested by the patient
Measured: Up to 24 hours
Patient number requiring postoperative additional analgesic
Number of patients who require paracetamol (15 mg/kg) and tramadol (1mg/kg) IV
Measured: Up to 24 hours
Complications / Side effects
Possible complications related to infraclavicular block (such as vascular puncture, hematoma, pneumothorax, diaphragma palsy...)
Measured: Up to 24 hours
Patient satisfaction
Satisfaction score: 0: very unsatisfied 3: very satisfied
Measured: Up to 24 hours
Surgeon satisfaction
Satisfaction score: 0: very unsatisfied, 3: very satisfied
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Jun 2022
- Primary completion1 May 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Prospective, Interventional
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260736
- Sponsor's protocol ID
- 2022/151
- Status last verified
- May 2023
- First submitted
- 20 Feb 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bingul ES, Canbaz M, Guzel M, Salviz EA, Akalin BE, Berkoz O, Emre Demirel E, Sungur Z, Savran Karadeniz M. Comparing the clinical features of lateral and medial approaches of costoclavicular technique versus traditional lateral sagittal technique as infraclavicular brachial plexus block methods: a randomized controlled trial. BMC Anesthesiol. 2024 Jul 25;24(1):254. doi: 10.1186/s12871-024-02645-z.
PubMed 39054425
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Costoclavicular Lateral, Costoclavicular Medial and Lateral Sagittal Approaches to Infraclavicular Brachial Plexus Block in Upper Extremity Surgery
- ClinicalTrials.gov ID
- NCT05260736
- Acronym / sponsor ID
- 2022/151
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infraclavicular block has taken its place in the literature as a proven technique in the anesthetic management of upper extremity surgeries. Compared to general anesthesia; The prominent advantages of regional anesthesia are that it provides longer perioperative pain control, reduces the incidence of postoperative nausea and vomiting, reduces opioid consumption and reduces the cost of hospitalization. The widespread use of ultrasonography (USG) in the last two decades has facilitated the application of the method and allowed the investigation of different injection methods.
Regional blocks are planned according to the surgery to be performed. For anesthesia of arm, forearm and hand operations; brachial plexus can be blocked in the axillary, infraclavicular, supraclavicular or interscalene region. The infraclavicular technique, on the other hand, is roughly divided into three types: costoclavicular lateral, costoclavicular medial and paracoracoid (Lateral sagittal). The image obtained by placing the ultrasonography probe in the relevant anatomical region serves as a guide for the orientation of the peripheral block needle and performing the intervention by observing the vascular structures in the existing region provides a great advantage in terms of patient safety.
In this study, we aimed to examine 3 different infraclavicular block methods; lateral costoclavicular, medial costoclavicular and lateral sagittal (Paracoracoid) approach, in terms of ease of application and motor/sensory block efficiency. Our hypothesis is that the sensory block will begin in a shorter time with costoclavicular methods compared to the lateral sagittal method. We are also planning to compare performance difficulties (needle maneuver numbers, subjective block exertion, block performance time etc.) for each type of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, Double-Blind, Prospective, Interventional
| Arm | Type | Receives |
|---|---|---|
| Group Costoclavicular Lateral (CL) | Active comparator | Procedure: Infraclavicular brachial plexus blockPatients anesthetized with costoclavicular lateral infraclavicular brachial plexus block. |
| Group Costoclavicular Medial (CM) | Active comparator | Procedure: Infraclavicular brachial plexus blockPatients anesthetized with costoclavicular medial infraclavicular brachial plexus block. |
| Group Lateral Sagittal (LS) | Active comparator | Procedure: Infraclavicular brachial plexus blockPatients anesthetized with lateral sagittal infraclavicular brachial plexus block. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective upper extremity surgeries (Arm, upper-arm and hand)
Key exclusion criteria (1 listed)
- Patients with bleeding diathesis Presence of infection on the intervention site Patients requiring continous anticoagulation therapy due to the existing comorbidities Patients with history of local anesthetic allergy Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infraclavicular brachial plexus blockNamed after the anatomical site; patients will be applied infraclavicular brachial plexus block with costoclavicular lateral, costoclavicular medial or lateral sagittal approach. | Procedure or surgery | Group Costoclavicular Lateral (CL), Group Costoclavicular Medial (CM), Group Lateral Sagittal (LS) |
Primary outcome
Sensory block onset time
Time frame: Up to 45 minutes.
Separately evaluated sensorial examination for four nerves (n. medianus, n. radialis, n. ulnaris, n. musculocutaneus), a total number of 6 points is accepted as "settled sensory block". 0= absent sensory block (feels pain), 1= partial sensory block (feels touch), 2= complete sensory block (no sense). Patients will be evaluated every 5 minutes after intervention.
11 secondary outcomes
Ideal USG guided brachial plexus cords visualization / needle pathway planning time
Time frame: Up to 15 minutes
Needle tip and shaft imaging visualization difficulty
Time frame: Up to 15 minutes
Requirement of additional maneuver due to insufficient local anesthetic distribution
Time frame: Up to 15 minutes
Total procedure difficulty according to anesthesiologist
Time frame: Up to 15 minutes
Patient number requiring rescue analgesics
Time frame: Intraoperative 2-4 hours
Motor blockade onset time
Time frame: Up to 45 minutes
Time to postoperative first pain
Time frame: Up to 24 hours
Patient number requiring postoperative additional analgesic
Time frame: Up to 24 hours
Complications / Side effects
Time frame: Up to 24 hours
Patient satisfaction
Time frame: Up to 24 hours
Surgeon satisfaction
Time frame: Up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 39054425Bingul ES, Canbaz M, Guzel M, Salviz EA, Akalin BE, Berkoz O, Emre Demirel E, Sungur Z, Savran Karadeniz M. Comparing the clinical features of lateral and medial approaches of costoclavicular technique versus traditional lateral sagittal technique as infraclavicular brachial plexus block methods: a randomized controlled trial. BMC Anesthesiol. 2024 Jul 25;24(1):254. doi: 10.1186/s12871-024-02645-z.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraclavicular brachial plexus block in people with Anesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory block onset time (time frame: Up to 45 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05260736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.