Brachial Plexus BlocksPhase 4NCT07374952
Minimal Effective Volume 90% for Double-injection Costoclavicular Block
A Phase 4 study testing Ultrasound-guided double-injection costoclavicular nerve block with same previous volume and Ultrasound-guided double-injection costoclavicular nerve block with lower volume in people with Brachial Plexus Blocks and Lidocaine, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
In 2020, a trial demonstrated that a 2-injection technique constitutes the optimal method for the costoclavicular block. This study aims to determine the minimum amount of medication required to achieve a successful double-injection costoclavicular nerve. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Brachial Plexus Blocks, Lidocaine, Nerve Block
- What is being tested?
- Ultrasound-guided double-injection costoclavicular nerve block with same previous volume and Ultrasound-guided double-injection costoclavicular nerve block with lower volume
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jun 2026to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Age between 18 and 70 years
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 30
Who cannot join
- Adults who are unable to give their own consent
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine≥ 100)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases≥ 100)
- Allergy to LA
Show all 9Show fewer
- Pregnancy
- Prior surgery in the infraclavicular region
- Chronic pain syndromes requiring opioid intake at home
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Julián Aliste, MD, 5149341934 ext. 43261, julian.aliste@mcgill.ca
About this study
Official title: Minimum Effective Volume of Lidocaine for Double-Injection Ultrasound-Guided Costoclavicular Block
In 2020, a trial demonstrated that a 2-injection technique constitutes the optimal method for the costoclavicular block.
This study aims to determine the minimum amount of medication required to achieve a successful double-injection costoclavicular nerve.
Read more
Block dose assignment will be done using an up-and-down sequential method, called the Biased Coin Design (BCD).
The double-injection technique for US-guided costoclavicular block consists in depositing two thirds of the LA volume in the deep compartment (to anesthetize the posterior and medial cords), and one third of the injectate in the superficial compartment (to anesthetize the lateral cord).
The ED90 will be calculated using isotonic regression with a 95% confidence interval derived by bootstrapping.
Read the detailed description
With the approval of the ethics committee of McGill University Health Centre, a total of 60 patients undergoing upper extremity surgery (elbow or below elbow) will be recruited.
The costoclavicular block will be performed under direct US vision until the tip is between the medial cord and the axillary artery. Two thirds of the volume of LA will be injected in this first location. Subsequently, the needle will be advanced until its tip is positioned next to the lateral cord. The remaining third of the LA volume will be injected in this second location.
Dose assignation will be done using an up-and-down sequential method, where the dose of each subsequent patient depends on the response of the previous patient, called the Biased Coin Design. The first subject recruited will receive a total of 30 mL of lidocaine 1.5 % with epinephrine 1: 200 000. Injection will be carried out by slow increments (5 mL) with negative aspiration between each increment.
The assignment of each subsequent dose will be based on the response of the previous patient as follows: if the previous patient did not have a successful block, the patient will receive the next higher dose, which is the previous dose incremented by 3.0 ml (i.e., an increment of 2.0 mL between the medial cord and the axillary artery, and an increment of 1.0 mL next to the lateral cord). If the previous patient had a successful block, the patient will be randomized to either receive the next lower dose, which is the previous dose decremented by 3.0 ml (i.e., a decrement of 2.0 mL between the medial cord and the axillary artery, and a decrement of 1.0 mL next to the lateral cord), with a probability b = 0.11, or to receive the same previous dose, with a probability 1 - b = 0.89. These are the probabilities required for assigning doses under the BCD for estimating ED90. A maximal dose of 40 mL will not be exceeded to avoid LA toxicity. If the previous patient did not respond and had been given the maximal dose the patient will also get the maximal dose. As soon as we recruit 45 patients with random dose assignment, we will terminate the enrollment procedure.
A research assistant will prepare and administer the injectate using syringes connected to the block needle. The operator and the patient will be blinded to the volume injected.
After LA injection at the second site, a catheter will be advanced 3 cm past the needle tip and secured to the skin. The purpose of the catheter is to allow LA supplementation for unsuccessful blocks, LA reinjection for lengthy surgical procedures or postoperative LA infusion for pain control.
The primary outcome is success rate which is defined as a minimal composite score of at least 14 points (out of a maximum of 16) is achieved at 30 minutes. The ED90 will be calculated using isotonic regression with a 95% confidence interval derived by bootstrapping .
- Being tested
- Ultrasound-guided double-injection costoclavicular nerve block with same previous volume, Ultrasound-guided double-injection costoclavicular nerve block with lower volume
- Keywords
- costoclavicular block, double injection technique, dose finding, nerve block, lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided double-injection costoclavicular nerve block with same previous volumeProcedure or surgery
ultrasound-guided double-injection costoclavicular nerve block with the same volume used in the previous successful block
Ultrasound-guided double-injection costoclavicular nerve block with lower volumeProcedure or surgery
Ultrasound-guided double-injection costoclavicular nerve block with lower volume than the previous successful block
| Study group | Role | What they receive |
|---|---|---|
| Costoclavicular block with same previous successful volume | Active comparator | Patients randomized to this group will receive the same volume that was successful in the previous recruitment. Receives: Procedure: Ultrasound-guided double-injection costoclavicular nerve block with same previous volume |
| Costoclavicular block with lower volume | Experimental | This group will be randomized to receive a fixed lower volume than the previously successful block. Receives: Procedure: Ultrasound-guided double-injection costoclavicular nerve block with lower volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate
The primary outcome is success rate evaluated by the sensorimotor block which is defined as a minimal composite score of at least 14 points (out of a maximum of 16) is achieved at 30 minutes.
The sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, median, radial, and ulnar nerves.
Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch.
The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis.
Successful blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 14 points out of 16.
Measured: 30 minutes
Secondary outcomes (7)
Operator level of experience
expert vs. trainee
Measured: 1 hour before surgery
The number of needle passes
The number of times the needle had to be withdrawn by ≥1 cm before redirecting to achieve the final position for local anesthetic injection.
Measured: 1 hour before surgery
Block performance time
Sum of: 1- the acquisition time of the ultrasonographic image. and 2- the time to perform the block itself (from the skin anesthesia to the end of local anesthetic injection)
Measured: 1 hour before surgery
Block onset time
Time required to reach a minimal sensorimotor composite score of 14 points out of a maximum of 16 points. The sensorimotor score is described in primary outcome.
Measured: 1 hour before surgery
Total anesthesia-related time
Sum of: 1- the performance time and 2- the onset time
Measured: 1 hour before surgery
Intensity of pain during block procedure
Evaluated with the Numeric Rating Scale for Pain. This scale is graduated from 0 to 10 points. A 0-point score represents the absence of pain, and a 10-points score represents the worst imaginable pain. Patients will be asked to rate their pain verbally with this scale. The blinded assessor will register the score reported.
Measured: 1 hour before surgery
Phrenic nerve block
presence of dyspnea in postanesthetic care unit
Measured: 1 hour after arrival to post anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start16 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Brachial Plexus BlocksStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Lidocaine dose finding study with an up-and-down methodology
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julián Aliste, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374952
- Sponsor's protocol ID
- COSTOCLAV DF 2026-11651
- Status last verified
- Jul 2026
- First submitted
- 21 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics. 2002 Mar;58(1):171-7. doi: 10.1111/j.0006-341x.2002.00171.x.
PubMed 11890313Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60.
PubMed 9192462Saranteas T, Finlayson RJ, Tran DQ. Dose-finding methodology for peripheral nerve blocks. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):550-5. doi: 10.1097/AAP.0000000000000157.
PubMed 25304484Layera S, Aliste J, Bravo D, Fernandez D, Garcia A, Finlayson RJ, Tran DQ. Single- versus double-injection costoclavicular block: a randomized comparison. Reg Anesth Pain Med. 2020 Mar;45(3):209-213. doi: 10.1136/rapm-2019-101167. Epub 2020 Jan 14.
PubMed 31941792Li JW, Songthamwat B, Samy W, Sala-Blanch X, Karmakar MK. Ultrasound-Guided Costoclavicular Brachial Plexus Block: Sonoanatomy, Technique, and Block Dynamics. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):233-240. doi: 10.1097/AAP.0000000000000566.
PubMed 28157792Karmakar 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 25899958
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Effective Volume of Lidocaine for Double-Injection Ultrasound-Guided Costoclavicular Block
- ClinicalTrials.gov ID
- NCT07374952
- Acronym / sponsor ID
- COSTOCLAV DF 2026-11651
- Keywords
- costoclavicular block, double injection technique, dose finding, nerve block, lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2026 (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.
In 2020, a trial demonstrated that a 2-injection technique constitutes the optimal method for the costoclavicular block.
This study aims to determine the minimum amount of medication required to achieve a successful double-injection costoclavicular nerve.
Block dose assignment will be done using an up-and-down sequential method, called the Biased Coin Design (BCD).
The double-injection technique for US-guided costoclavicular block consists in depositing two thirds of the LA volume in the deep compartment (to anesthetize the posterior and medial cords), and one third of the injectate in the superficial compartment (to anesthetize the lateral cord).
The ED90 will be calculated using isotonic regression with a 95% confidence interval derived by bootstrapping.
Detailed description
With the approval of the ethics committee of McGill University Health Centre, a total of 60 patients undergoing upper extremity surgery (elbow or below elbow) will be recruited.
The costoclavicular block will be performed under direct US vision until the tip is between the medial cord and the axillary artery. Two thirds of the volume of LA will be injected in this first location. Subsequently, the needle will be advanced until its tip is positioned next to the lateral cord. The remaining third of the LA volume will be injected in this second location.
Dose assignation will be done using an up-and-down sequential method, where the dose of each subsequent patient depends on the response of the previous patient, called the Biased Coin Design. The first subject recruited will receive a total of 30 mL of lidocaine 1.5 % with epinephrine 1: 200 000. Injection will be carried out by slow increments (5 mL) with negative aspiration between each increment.
The assignment of each subsequent dose will be based on the response of the previous patient as follows: if the previous patient did not have a successful block, the patient will receive the next higher dose, which is the previous dose incremented by 3.0 ml (i.e., an increment of 2.0 mL between the medial cord and the axillary artery, and an increment of 1.0 mL next to the lateral cord). If the previous patient had a successful block, the patient will be randomized to either receive the next lower dose, which is the previous dose decremented by 3.0 ml (i.e., a decrement of 2.0 mL between the medial cord and the axillary artery, and a decrement of 1.0 mL next to the lateral cord), with a probability b = 0.11, or to receive the same previous dose, with a probability 1 - b = 0.89. These are the probabilities required for assigning doses under the BCD for estimating ED90. A maximal dose of 40 mL will not be exceeded to avoid LA toxicity. If the previous patient did not respond and had been given the maximal dose the patient will also get the maximal dose. As soon as we recruit 45 patients with random dose assignment, we will terminate the enrollment procedure.
A research assistant will prepare and administer the injectate using syringes connected to the block needle. The operator and the patient will be blinded to the volume injected.
After LA injection at the second site, a catheter will be advanced 3 cm past the needle tip and secured to the skin. The purpose of the catheter is to allow LA supplementation for unsuccessful blocks, LA reinjection for lengthy surgical procedures or postoperative LA infusion for pain control.
The primary outcome is success rate which is defined as a minimal composite score of at least 14 points (out of a maximum of 16) is achieved at 30 minutes. The ED90 will be calculated using isotonic regression with a 95% confidence interval derived by bootstrapping .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Lidocaine dose finding study with an up-and-down methodology
| Arm | Type | Receives |
|---|---|---|
| Costoclavicular block with same previous successful volume | Active comparator | Procedure: Ultrasound-guided double-injection costoclavicular nerve block with same previous volumePatients randomized to this group will receive the same volume that was successful in the previous recruitment. |
| Costoclavicular block with lower volume | Experimental | Procedure: Ultrasound-guided double-injection costoclavicular nerve block with lower volumeThis group will be randomized to receive a fixed lower volume than the previously successful block. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 70 years
- American Society of Anesthesiologists classification 1-3
- Body mass index between 20 and 30
Key exclusion criteria (9 listed)
- Adults who are unable to give their own consent
- Pre-existing neuropathy (assessed by history and physical examination)
- Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
- Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine≥ 100)
- Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases≥ 100)
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 |
|---|---|---|
| Ultrasound-guided double-injection costoclavicular nerve block with same previous volumeultrasound-guided double-injection costoclavicular nerve block with the same volume used in the previous successful block | Procedure or surgery | Costoclavicular block with same previous successful volume |
| Ultrasound-guided double-injection costoclavicular nerve block with lower volumeUltrasound-guided double-injection costoclavicular nerve block with lower volume than the previous successful block | Procedure or surgery | Costoclavicular block with lower volume |
Primary outcome
Success rate
Time frame: 30 minutes
The primary outcome is success rate evaluated by the sensorimotor block which is defined as a minimal composite score of at least 14 points (out of a maximum of 16) is achieved at 30 minutes. The sensorimotor block will be assessed every 5 minutes until 30 minutes after the end of local anesthetic injection using a 16-point composite score evaluating sensory and motor block of musculocutaneous, median, radial, and ulnar nerves. Sensation will be assessed with ice in each nerve territory with a 0 to 2 point scale. 0= no block, patients can feel cold; 1= analgesic block, the patient can feel touch but not cold; 2= anesthetic block, the patient cannot feel cold or touch. The motor function will be assessed for each nerve with a 0 to 2 points scale where 0= no motor block; 1= paresis; 2= paralysis. Successful blocks at 30 minutes correlate with a final score ( sum of all individual sensory and motor scores) of at least 14 points out of 16.
7 secondary outcomes
Operator level of experience
Time frame: 1 hour before surgery
The number of needle passes
Time frame: 1 hour before surgery
Block performance time
Time frame: 1 hour before surgery
Block onset time
Time frame: 1 hour before surgery
Total anesthesia-related time
Time frame: 1 hour before surgery
Intensity of pain during block procedure
Time frame: 1 hour before surgery
Phrenic nerve block
Time frame: 1 hour after arrival to post anesthesia care unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 11890313Stylianou M, Flournoy N. Dose finding using the biased coin up-and-down design and isotonic regression. Biometrics. 2002 Mar;58(1):171-7. doi: 10.1111/j.0006-341x.2002.00171.x.
- Background: PubMed 9192462Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60.
- Background: PubMed 25304484Saranteas T, Finlayson RJ, Tran DQ. Dose-finding methodology for peripheral nerve blocks. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):550-5. doi: 10.1097/AAP.0000000000000157.
- Background: PubMed 31941792Layera S, Aliste J, Bravo D, Fernandez D, Garcia A, Finlayson RJ, Tran DQ. Single- versus double-injection costoclavicular block: a randomized comparison. Reg Anesth Pain Med. 2020 Mar;45(3):209-213. doi: 10.1136/rapm-2019-101167. Epub 2020 Jan 14.
- Background: PubMed 28157792Li JW, Songthamwat B, Samy W, Sala-Blanch X, Karmakar MK. Ultrasound-Guided Costoclavicular Brachial Plexus Block: Sonoanatomy, Technique, and Block Dynamics. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):233-240. doi: 10.1097/AAP.0000000000000566.
- 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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound-guided double-injection costoclavicular nerve block with same previous volume and Ultrasound-guided double-injection costoclavicular nerve block with lower volume in people with Brachial Plexus Blocks and Lidocaine, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 9 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julián Aliste, M.D. (+15149341934-43795, julian.aliste@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate (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 NCT07374952, which also lists 6 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 7 Jul 2026.