Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 .
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Costoclavicular block with lower volume | Experimental | This group will be randomized to receive a fixed lower volume than the previously successful block. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided double-injection costoclavicular nerve block with same previous volume | Procedure | ultrasound-guided double-injection costoclavicular nerve block with the same volume used in the previous successful block |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Operator level of experience | expert vs. trainee | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of nerve block side effects | The presence of Horner syndrome, paresthesia, vascular puncture, hematoma, pneumothorax, or local anesthetic systemic toxicity after the nerve block. | From skin anesthesia to 60 minutes after the nerve block |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julián Aliste, M.D. | Contact | +15149341934-43795 | julian.aliste@mcgill.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal General Hospital | Recruiting | Montreal | Quebec | H3G 1A4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11890313 | Background | 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. | |
| 9192462 | Background | Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Lidocaine dose finding study with an up-and-down methodology
Not provided
Not provided
A research assistant (a licensed anesthesiologist) will prepare the local anesthetic (lidocaine) solutions according to the sequential allocation. The operator, patient, and outcome assessor will remain blinded to the assignment.
| Ultrasound-guided double-injection costoclavicular nerve block with lower volume | Procedure | Ultrasound-guided double-injection costoclavicular nerve block with lower volume than the previous successful block |
|
| 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) | 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. | 1 hour before surgery |
| Total anesthesia-related time | Sum of: 1- the performance time and 2- the onset time | 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. | 1 hour before surgery |
| Phrenic nerve block | presence of dyspnea in postanesthetic care unit | 1 hour after arrival to post anesthesia care unit |
| 25304484 | Background | Saranteas 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. |
| 31941792 | Background | Layera 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. |
| 28157792 | Background | Li 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. |
| 25899958 | Background | 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. |