AnesthesiaNCT04757896
Costoclavicular Blockage for Upper Limb Surgery
A study testing Lateral costoclavicular approach and Medial costoclavicular approach in people with Anesthesia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the success of surgical anesthesia of lateral and medial approaches of the costoclavicular block in patients undergoing upper extremity surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Lateral costoclavicular approach and Medial costoclavicular approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2020to 28 Apr 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective or emergency upper limb surgery
- Between 18 to 80 years old
- ASA I-IV
Who cannot join
- <18 years old/ >80 Years old
- >ASA IV
- Any serious illness
- Anticoagulant/antiaggregate treatments
- Any allergies to the drugs that used in study
- İnfections or open wounds at the operation area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound Guided Medial Approach and Lateral Approach of the Costoclavicular Blockage: A Prospective Randomised Study
To evaluate the success of surgical anesthesia of lateral and medial approaches of the costoclavicular block in patients undergoing upper extremity surgery.
Read the detailed description
Introduction:Upper limb surgeries are used on various pathology cases including tendon injuries, carpal tunnel syndrome, tenosynovitis, fractures secondary to trauma, contractures and vascular injuries. In many of such operations local anaesthesia becomes insufficient, and general or regional anaesthesia is required for comfort of the patient and the surgeon. Today, widespread use of nerve stimulators and ultrasound, the availability of post-operative pain management options, applicability of regional anaesthesia where there is risk of complications with general anaesthesia and its applicability along with general anaesthesia for pain management has made regional anaesthesia an attractive solution.The costoclavicular cavity lies in the depth and back of the median of clavicular. It connects to subclavius and clavicular terminus of pectoralis major muscle at the anterior and to the anterior chest wall at the posterior. The cavity is cranially continuous with the supraclavicular fossa and caudally continuous with the medial infraclavicular fossa above the upper border of the pectoralis minor muscle. Unlike the lateral infraclavicular fossa, the cords lie in the costoclavicular cavity in a relatively superficial form in a bundled triangular arrangement. Anatomical layout of cords in the costoclavicular cavity makes this an attractive area for ultrasound imaging and infraclavicular brachial plexus blockage. After placing the linear ultrasound probe on the midclavicular line and even in parallel to the clavicular, the three cords are imaged along with the axillary artery, whereupon local anaesthetic injection can be made with in-plane technique, directing the needle from lateral to medial.
Medial approach to costoclavicular block defined by Nieuwveld involves placement of the linear ultrasound probe on the midclavicular line in parallel with the clavicular, as in the lateral approach, followed by imaging of the three cords alongside the axillary artery, whereupon the needle is directed from the medial to the lateral with the in-plane technique and applying local anaesthetic injection to the midpoint of three cords.
The sample size calculation is done based on the time for establishing total anaesthesia and anaesthesia lead time variables in reference to the study conducted by Prangmalee Leurcharusmee et al. Calculating for 16±5 for lateral approach and 21±7 for medial approach, it is calculated that each group should include 44 patients at 80% power and 95% reliability rate for a meaningful difference at 5 minutes, requiring a total of 88 patients.After obtaining approval of the local ethics board, 88 patients who are considered for emergency or elective superior extremity surgery, in ASA I-IV group, in 18 to 75 age group, who do not have any known serious illness and who consent to participate will be included in the study.
Material and Method:Patients in ASA IV group and above, patients taking anticoagulant/antiaggregate treatments, patients with nervous disorders, patients with infections or open wounds at the operation area and patients with allergies against any drug to be used in the study will be excluded from the study.
Patients participating in the study will be randomly divided into 2 separate groups. These groups will be referred to as the Group M (Medial approach group) and Group L (Lateral approach group).
Patients will be reviewed before being taken to operating room, they will be informed regarding the considered operation and their consent will be taken. Patients will be moved to regional anaesthesia room before the operation, where they will be equipped with fingertip oxygen saturation monitoring and 20-22 gauge intravenous channel. After confirming operation area sterilisation will be done with skin antiseptic, the operation area will be covered with sterilised cover and linear USG probe will be prepared in sterile conditions. All procedures will be implemented by an experienced anaesthesiologist. A blind researcher will review the patients and the surgical team will also be kept blind regarding the type of procedure.
In Group M, after the patient will be taken to the regional anaesthesia room and preparations will be made, the blockage procedure will be applied by an anaesthesiologist who is not blind. The patient will be brought to supine position, the arm subject to procedure will be taken to 90° abduction with the palm looking at the ceiling. The Linear USG probe will be positioned on the midclavicular line and the chronometer will be started to record the scanning procedure time as the time elapsed until imaging of the axillary artery alongside with the three cords. After achieving optimum imaging skin infiltration will be applied with 1% lidocaine and an 80-100 mm needle will be directed from the medial to the lateral with the in-plane technique and the blockage procedure will be completed by injecting a combination of 10 cc 2% lidocaine and 10 cc 0.5% bupivacaine in the exact midpoint of the three cords.
In Group L, again the patient will be taken to the regional anaesthesia room and preparations will be made, and the blockage procedure will be applied by an anaesthesiologist who is not blind. The patient will be brought to supine position, the arm subject to procedure will be taken to 90° abduction with the palm looking at the ceiling. The Linear USG probe will be positioned on the midclavicular line and the chronometer will be started to record the scanning procedure time as the time elapsed until imaging of the axillary artery alongside with the three cords. After achieving optimum imaging skin infiltration will be applied with 1% lidocaine and an 80-100 mm needle will be directed from the medial to the lateral with the in-plane technique and the blockage procedure will be completed by injecting a combination of 10 cc 2% lidocaine and 10 cc 0.5% bupivacaine in the exact midpoint of the three cords.
The total procedure time, the complications arising during procedure, the local anaesthetic toxicity, the paraesthesia arising during the procedure, the distance between the needle tip and the pleura and the number of needle passes will be recorded for each procedure. A blind researcher will evaluate sensory blockage by checking radial, musculocutaneous, medial and ulnar nerve dermatomes with ice using triple point scale (0= no blockage, patient completely feels the cold; 1= analgesia, the patient does not feel the cold but feels the touch; 2= anaesthesia, the patient does not feel the touch) once per 5 minutes for 30/45 minutes taking the moment of needle removal as the 0 point. Motor block will also be evaluated by triple point scale (0=no blockage; 1=paraesthesia established; 2=paralysis established) once per 5 minutes for 30 minutes. Motor blockage at musculocutaneous, radial, median and ulnar nerves will be evaluated by elbow flexion, thumb abduction, thumb opposition and thumb adduction, in this order. Sensory and motor blockage starting time points and total anaesthesia establishment time points will be recorded. At 20/30 minutes point convex (M mode) USG probe will be used to evaluate diaphragmatic paralysis. Once surgical anaesthesia is established the operation will be started, the patient will be monitored throughout the operation, additional analgesia-sedation needs, returns to general anaesthesia and total surgery times will be recorded. After surgical operation is completed, patient and surgeon satisfaction will be questioned.
- Conditions
- Anesthesia
- Being tested
- Lateral costoclavicular approach, Medial costoclavicular approach
- Keywords
- brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral costoclavicular approachProcedure or surgery
USG guided lateral costoclavicular approach for brachial plexus block
Medial costoclavicular approachProcedure or surgery
USG guided medial costoclavicular approach for brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| Costoclavicular block lateral aproach | Active comparator | An 80-100 mm needle will be directed from the lateral to the medial with the ultrasound guided in-plane technique and the blockage procedure will be completed by injecting Receives: Procedure: Lateral costoclavicular approach |
| Costoclavicular block medial aproach | Active comparator | An 80-100 mm needle will be directed from the medial to the lateral with the ultrasound guided in-plane technique and the blockage procedure will be completed by injecting Receives: Procedure: Medial costoclavicular approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
success in providing surgical anesthesia via triple point scale evaluation
The triple point scale (0= no blockage, patient completely feels the cold; 1= analgesia, the patient does not feel the cold but feels the touch; 2= anaesthesia, the patient does not feel the touch) once per 5 minutes for 30/45 minutes taking the moment of needle removal as the 0 point. Motor block will also be evaluated by triple point scale (0=no blockage; 1=paraesthesia established; 2=paralysis established) once per 5 minutes for 30 minutes.
Measured: 30 minutes
Secondary outcomes (1)
Initiation time of block
Sensory and motor block initiation time
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start25 Dec 2020
- Primary completion30 Mar 2021
- Study completion28 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Assignment
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Ince, Ataturk University
- Investigators
- ataturk unıversity, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757896
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/540
- Status last verified
- Apr 2021
- First submitted
- 1 Feb 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.
PubMed 25899958Nieuwveld D, Mojica V, Herrera AE, Pomes J, Prats A, Sala-Blanch X. Medial approach of ultrasound-guided costoclavicular plexus block and its effects on regional perfussion. Rev Esp Anestesiol Reanim. 2017 Apr;64(4):198-205. doi: 10.1016/j.redar.2016.09.010. Epub 2016 Dec 9. English, Spanish.
PubMed 27938934Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15.
PubMed 28205117
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Medial Approach and Lateral Approach of the Costoclavicular Blockage: A Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT04757896
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/540
- Conditions
- Anesthesia
- Keywords
- brachial plexus block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 Dec 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 28 Apr 2021 (actual)
- First posted
- 17 Feb 2021 (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.
To evaluate the success of surgical anesthesia of lateral and medial approaches of the costoclavicular block in patients undergoing upper extremity surgery.
Detailed description
Introduction:Upper limb surgeries are used on various pathology cases including tendon injuries, carpal tunnel syndrome, tenosynovitis, fractures secondary to trauma, contractures and vascular injuries. In many of such operations local anaesthesia becomes insufficient, and general or regional anaesthesia is required for comfort of the patient and the surgeon. Today, widespread use of nerve stimulators and ultrasound, the availability of post-operative pain management options, applicability of regional anaesthesia where there is risk of complications with general anaesthesia and its applicability along with general anaesthesia for pain management has made regional anaesthesia an attractive solution.The costoclavicular cavity lies in the depth and back of the median of clavicular. It connects to subclavius and clavicular terminus of pectoralis major muscle at the anterior and to the anterior chest wall at the posterior. The cavity is cranially continuous with the supraclavicular fossa and caudally continuous with the medial infraclavicular fossa above the upper border of the pectoralis minor muscle. Unlike the lateral infraclavicular fossa, the cords lie in the costoclavicular cavity in a relatively superficial form in a bundled triangular arrangement. Anatomical layout of cords in the costoclavicular cavity makes this an attractive area for ultrasound imaging and infraclavicular brachial plexus blockage. After placing the linear ultrasound probe on the midclavicular line and even in parallel to the clavicular, the three cords are imaged along with the axillary artery, whereupon local anaesthetic injection can be made with in-plane technique, directing the needle from lateral to medial.
Medial approach to costoclavicular block defined by Nieuwveld involves placement of the linear ultrasound probe on the midclavicular line in parallel with the clavicular, as in the lateral approach, followed by imaging of the three cords alongside the axillary artery, whereupon the needle is directed from the medial to the lateral with the in-plane technique and applying local anaesthetic injection to the midpoint of three cords.
The sample size calculation is done based on the time for establishing total anaesthesia and anaesthesia lead time variables in reference to the study conducted by Prangmalee Leurcharusmee et al. Calculating for 16±5 for lateral approach and 21±7 for medial approach, it is calculated that each group should include 44 patients at 80% power and 95% reliability rate for a meaningful difference at 5 minutes, requiring a total of 88 patients.After obtaining approval of the local ethics board, 88 patients who are considered for emergency or elective superior extremity surgery, in ASA I-IV group, in 18 to 75 age group, who do not have any known serious illness and who consent to participate will be included in the study.
Material and Method:Patients in ASA IV group and above, patients taking anticoagulant/antiaggregate treatments, patients with nervous disorders, patients with infections or open wounds at the operation area and patients with allergies against any drug to be used in the study will be excluded from the study.
Patients participating in the study will be randomly divided into 2 separate groups. These groups will be referred to as the Group M (Medial approach group) and Group L (Lateral approach group).
Patients will be reviewed before being taken to operating room, they will be informed regarding the considered operation and their consent will be taken. Patients will be moved to regional anaesthesia room before the operation, where they will be equipped with fingertip oxygen saturation monitoring and 20-22 gauge intravenous channel. After confirming operation area sterilisation will be done with skin antiseptic, the operation area will be covered with sterilised cover and linear USG probe will be prepared in sterile conditions. All procedures will be implemented by an experienced anaesthesiologist. A blind researcher will review the patients and the surgical team will also be kept blind regarding the type of procedure.
In Group M, after the patient will be taken to the regional anaesthesia room and preparations will be made, the blockage procedure will be applied by an anaesthesiologist who is not blind. The patient will be brought to supine position, the arm subject to procedure will be taken to 90° abduction with the palm looking at the ceiling. The Linear USG probe will be positioned on the midclavicular line and the chronometer will be started to record the scanning procedure time as the time elapsed until imaging of the axillary artery alongside with the three cords. After achieving optimum imaging skin infiltration will be applied with 1% lidocaine and an 80-100 mm needle will be directed from the medial to the lateral with the in-plane technique and the blockage procedure will be completed by injecting a combination of 10 cc 2% lidocaine and 10 cc 0.5% bupivacaine in the exact midpoint of the three cords.
In Group L, again the patient will be taken to the regional anaesthesia room and preparations will be made, and the blockage procedure will be applied by an anaesthesiologist who is not blind. The patient will be brought to supine position, the arm subject to procedure will be taken to 90° abduction with the palm looking at the ceiling. The Linear USG probe will be positioned on the midclavicular line and the chronometer will be started to record the scanning procedure time as the time elapsed until imaging of the axillary artery alongside with the three cords. After achieving optimum imaging skin infiltration will be applied with 1% lidocaine and an 80-100 mm needle will be directed from the medial to the lateral with the in-plane technique and the blockage procedure will be completed by injecting a combination of 10 cc 2% lidocaine and 10 cc 0.5% bupivacaine in the exact midpoint of the three cords.
The total procedure time, the complications arising during procedure, the local anaesthetic toxicity, the paraesthesia arising during the procedure, the distance between the needle tip and the pleura and the number of needle passes will be recorded for each procedure. A blind researcher will evaluate sensory blockage by checking radial, musculocutaneous, medial and ulnar nerve dermatomes with ice using triple point scale (0= no blockage, patient completely feels the cold; 1= analgesia, the patient does not feel the cold but feels the touch; 2= anaesthesia, the patient does not feel the touch) once per 5 minutes for 30/45 minutes taking the moment of needle removal as the 0 point. Motor block will also be evaluated by triple point scale (0=no blockage; 1=paraesthesia established; 2=paralysis established) once per 5 minutes for 30 minutes. Motor blockage at musculocutaneous, radial, median and ulnar nerves will be evaluated by elbow flexion, thumb abduction, thumb opposition and thumb adduction, in this order. Sensory and motor blockage starting time points and total anaesthesia establishment time points will be recorded. At 20/30 minutes point convex (M mode) USG probe will be used to evaluate diaphragmatic paralysis. Once surgical anaesthesia is established the operation will be started, the patient will be monitored throughout the operation, additional analgesia-sedation needs, returns to general anaesthesia and total surgery times will be recorded. After surgical operation is completed, patient and surgeon satisfaction will be questioned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Costoclavicular block lateral aproach | Active comparator | Procedure: Lateral costoclavicular approachAn 80-100 mm needle will be directed from the lateral to the medial with the ultrasound guided in-plane technique and the blockage procedure will be completed by injecting |
| Costoclavicular block medial aproach | Active comparator | Procedure: Medial costoclavicular approachAn 80-100 mm needle will be directed from the medial to the lateral with the ultrasound guided in-plane technique and the blockage procedure will be completed by injecting |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective or emergency upper limb surgery
- Between 18 to 80 years old
- ASA I-IV
Key exclusion criteria (6 listed)
- <18 years old/ >80 Years old
- >ASA IV
- Any serious illness
- Anticoagulant/antiaggregate treatments
- Any allergies to the drugs that used in study
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 |
|---|---|---|
| Lateral costoclavicular approachUSG guided lateral costoclavicular approach for brachial plexus block | Procedure or surgery | Costoclavicular block lateral aproach |
| Medial costoclavicular approachUSG guided medial costoclavicular approach for brachial plexus block | Procedure or surgery | Costoclavicular block medial aproach |
Primary outcome
success in providing surgical anesthesia via triple point scale evaluation
Time frame: 30 minutes
The triple point scale (0= no blockage, patient completely feels the cold; 1= analgesia, the patient does not feel the cold but feels the touch; 2= anaesthesia, the patient does not feel the touch) once per 5 minutes for 30/45 minutes taking the moment of needle removal as the 0 point. Motor block will also be evaluated by triple point scale (0=no blockage; 1=paraesthesia established; 2=paralysis established) once per 5 minutes for 30 minutes.
1 secondary outcome
Initiation time of block
Time frame: 30 minutes
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 30 Apr 2021.
- Background: PubMed 25899958Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.
- Background: PubMed 27938934Nieuwveld D, Mojica V, Herrera AE, Pomes J, Prats A, Sala-Blanch X. Medial approach of ultrasound-guided costoclavicular plexus block and its effects on regional perfussion. Rev Esp Anestesiol Reanim. 2017 Apr;64(4):198-205. doi: 10.1016/j.redar.2016.09.010. Epub 2016 Dec 9. English, Spanish.
- Background: PubMed 28205117Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15.
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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.
ataturk unıversity principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral costoclavicular approach and Medial costoclavicular approach in people with Anesthesia, run by Ataturk 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 3 inclusion and 6 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 30 Apr 2021. 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?
success in providing surgical anesthesia via triple point scale evaluation (time frame: 30 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 NCT04757896, which also lists 3 linked publications.
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 30 Apr 2021.