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The purpose of this study is to compare the rate of complete sensory block at 30 minutes following ultrasound-guided single injection infraclavicular block and ultrasound-guided double injection axillary block. The investigators research hypothesis is that both blocks will show comparable rates of complete sensory block at 30 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound-guided infraclavicular block | Active Comparator | Ultrasound-guided single injection infraclavicular block |
|
| Ultrasound-guided axillary block | Active Comparator | Ultrasound-guided double injection axillary block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound-guided infraclavicular block | Procedure | Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Complete Sensory Block | Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories. | 30 minutes after block completion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Complete Motor Blocks | Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories. | 30 minutes after block completion |
| Time to Complete Sensory Block. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariane Boivin, MD | CHU de Québec | Principal Investigator |
| Marie-Josée Nadeau, MD | CHU de Québec | Principal Investigator |
| Nicolas Dion, MD | CHU de Québec | Principal Investigator |
| Simon Lévesque, MD | CHU de Québec | Principal Investigator |
| Pierre C. Nicole, MD | CHU de Québec | Principal Investigator |
| Alexis F. Turgeon, MD, Msc | CHU de Québec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de l'Enfant-Jésus | Québec | G1J 1Z4 | Canada | |||
| Hôpital de Saint-Sacrement |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26516803 | Derived | Boivin A, Nadeau MJ, Dion N, Levesque S, Nicole PC, Turgeon AF. Ultrasound-Guided Single-Injection Infraclavicular Block Versus Ultrasound-Guided Double-Injection Axillary Block: A Noninferiority Randomized Controlled Trial. Anesth Analg. 2016 Jan;122(1):273-8. doi: 10.1213/ANE.0000000000001017. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound-guided Infraclavicular Block | Ultrasound-guided single injection infraclavicular block Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery. |
| FG001 | Ultrasound-guided Axillary Block | Ultrasound-guided double injection axillary block Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Considering a rate of complete sensory block of 90% for the infraclavicular block and a noninferiority margin of 10%, a sample size of 224 patients was needed to evaluate the noninferiority of the axillary block in comparison to the infraclavicular block at 30 minutes, with a power of 80% and an alpha error of 5% (one-sided hypothesis).
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound-guided Infraclavicular Block | Ultrasound-guided single injection infraclavicular block Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Complete Sensory Block | Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories. | Statistical analyses were conducted according to the intention-to-treat principle | Posted | Number | 90% Confidence Interval | percentage of participants | 30 minutes after block completion |
|
1 month
Patients were contacted at 24 hours and 1 month following their surgery by an investigator blinded to the technique. Standardized questions were asked about potential complications including signs of injection of hematoma at the puncture site or residual numbness, loss of sensitivity or weakness in the operated limb related to block performance.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasound-guided Infraclavicular Block | Ultrasound-guided single injection infraclavicular block Ultrasound-guided infraclavicular block: Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery looking for a crescent-shaped distribution around the artery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local anesthetic toxicity | Nervous system disorders | Systematic Assessment | Mild signs of local anesthetic toxicity including tinnitus, circumoral numbness, drowsiness, lightheadedness or metallic taste. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dre Marie-Josée Nadeau | CHU de Québec, Département d'Anesthésie-Réanimation de l'Hôpital de l'Enfant-Jésus | 418 649-5807 | marie-josee.nadeau@fmed.ulaval.ca |
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| Ultrasound-guided axillary block | Procedure | Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected postero-medial to the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve. |
|
Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.
| 5, 10, 15, 20, 25 and 30 minutes after block completion |
| Time to Complete Motor Block | Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories. | 5, 10, 15, 20, 25 and 30 minutes after block completion |
| Surgical Block Success Rate | Surgical block success is defined by a nerve block allowing surgery without a rescue block, an infiltration of local anesthetics by the surgeon, administration of analgesics for pain in the surgical field or a general anesthesia. | End of surgery |
| Performance Time of the Nerve Block | Performance time is defined as the sum of imaging time (defined as the time elapsed from the moment the Doppler probe is in contact with the patient to the insertion of the Tuohy needle) and needling time (from the insertion of the needle to its complete removal). | During the performance of the block |
| Procedure-related Pain on a Visual Analog Pain Scale | Pain was evaluated by the patient on a visual analog pain scale ranging from 0 (no pain) to 10 (worst pain of their life). | After the nerve block procedure ended, up to 5 minutes. |
| Number of Patients With Postoperative Adverse Events Related to Nerve Block | Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site. | 24 hours after surgery |
| Number of Patients With Postoperative Adverse Events Related to Nerve Block | Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site. | 1 month after surgery |
| Duration of Surgery | The end of surgery |
| Tourniquet Use | Number of participants who had a tourniquet during the surgery | The end of surgery |
| Duration of Tourniquet | The total time the tourniquet was left inflated | The end of surgery |
| Québec |
| G1S 4L8 |
| Canada |
| BG001 |
| Ultrasound-guided Axillary Block |
Ultrasound-guided double injection axillary block Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes | Number | participants |
|
| American Society of Anesthesiologists (ASA) preoperative classification | ASA 1: A normal healthy patient ASA 2: A patient with mild systemic disease with no functional limitation ASA 3: A patient with severe systemic disease and functional limitations | Number | participants |
|
| Site of surgery | Number | participants |
|
| Ultrasound-guided Axillary Block |
Ultrasound-guided double injection axillary block Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve. |
|
|
|
| Secondary | Number of Patients With Complete Motor Blocks | Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories. | Posted | Number | 95% Confidence Interval | percentage of participants | 30 minutes after block completion |
|
|
|
|
| Secondary | Time to Complete Sensory Block. | Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories. | One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes. | Posted | Number | 95% Confidence Interval | percentage of participants | 5, 10, 15, 20, 25 and 30 minutes after block completion |
|
|
|
|
| Secondary | Time to Complete Motor Block | Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories. | One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes. | Posted | Number | 95% Confidence Interval | percentage of participants | 5, 10, 15, 20, 25 and 30 minutes after block completion |
|
|
|
|
| Secondary | Surgical Block Success Rate | Surgical block success is defined by a nerve block allowing surgery without a rescue block, an infiltration of local anesthetics by the surgeon, administration of analgesics for pain in the surgical field or a general anesthesia. | Posted | Number | 95% Confidence Interval | percentage of participants | End of surgery |
|
|
|
|
| Secondary | Performance Time of the Nerve Block | Performance time is defined as the sum of imaging time (defined as the time elapsed from the moment the Doppler probe is in contact with the patient to the insertion of the Tuohy needle) and needling time (from the insertion of the needle to its complete removal). | One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes. | Posted | Mean | 95% Confidence Interval | seconds | During the performance of the block |
|
|
|
|
| Secondary | Procedure-related Pain on a Visual Analog Pain Scale | Pain was evaluated by the patient on a visual analog pain scale ranging from 0 (no pain) to 10 (worst pain of their life). | One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success. This patient was not included in the other secondary outcomes. 3 other participants had missing data for this outcome. | Posted | Median | Inter-Quartile Range | units on a scale | After the nerve block procedure ended, up to 5 minutes. |
|
|
|
|
| Secondary | Number of Patients With Postoperative Adverse Events Related to Nerve Block | Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site. | Four patients in the infraclavicular group and six in the axillary group could not be contacted in the pre-established time frame. | Posted | Number | participants | 24 hours after surgery |
|
|
|
| Secondary | Number of Patients With Postoperative Adverse Events Related to Nerve Block | Adverse events were defined by residual numbness, loss of sensitivity or weakness in the operated arm related to block performance or signs of hematoma or infection at the puncture site. | Eight patients in the infraclavicular group and five in the axillary group could not be contacted in the pre-established time frame. | Posted | Number | participants | 1 month after surgery |
|
|
|
| Secondary | Duration of Surgery | One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes. | Posted | Median | Inter-Quartile Range | minutes | The end of surgery |
|
|
|
| Secondary | Tourniquet Use | Number of participants who had a tourniquet during the surgery | One patient in the infraclavicular block had an anatomic variation precluding block performance. He was considered a block failure for the primary outcome and for the secondary outcomes of complete motor block and surgical success, on the basis of an intention-to-treat analysis. This patient was not included in the remaining secondary outcomes. | Posted | Number | participants | The end of surgery |
|
|
|
| Secondary | Duration of Tourniquet | The total time the tourniquet was left inflated | Posted | Median | Inter-Quartile Range | minutes | The end of surgery |
|
|
|
| 0 |
| 112 |
| 3 |
| 112 |
| EG001 | Ultrasound-guided Axillary Block | Ultrasound-guided double injection axillary block Ultrasound-guided axillary block: Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected in order to obtain a postero-medial spread around the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve. | 0 | 112 | 1 | 112 |
|
| Horner syndrome | Nervous system disorders | Non-systematic Assessment | Ptosis, miosis, and anhidrosis of the side of the face ipsilateral to the block performed |
|
| Hematoma | Skin and subcutaneous tissue disorders | Systematic Assessment | Hematoma at the puncture site |
|
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| 15 minutes |
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| 20 minutes |
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| 25 minutes |
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| 30 minutes |
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| 15 minutes |
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| 20 minutes |
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| 25 minutes |
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| 30 minutes |
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