Anesthesia
Conditions
Brief summary
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* 18 years or older * American Society of Anesthesiologists Class 1 to 3 * Undergoing a surgery at the elbow, forearm, wrist or hand under regional anesthesia
Exclusion criteria
* Age less than 18 years * Body mass index more than 40 kg/m2 * Weight less than 45 kg * Patient refusal * Contraindication to regional anesthesia (coagulopathy, local infection at the puncture site, systemic infection) * Previous neurological deficit in the operated arm * Severe renal or hepatic failure * Prior surgery in the axillary or infraclavicular area * Pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Complete Sensory Block | 30 minutes after block completion | Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Sensory Block. | 5, 10, 15, 20, 25 and 30 minutes after block completion | Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories. |
| Time to Complete Motor Block | 5, 10, 15, 20, 25 and 30 minutes after block completion | Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories. |
| Surgical Block Success Rate | End of surgery | 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. |
| Performance Time of the Nerve Block | During the performance of the 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). |
| Number of Patients With Complete Motor Blocks | 30 minutes after block completion | Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories. |
| Number of Patients With Postoperative Adverse Events Related to Nerve Block | 24 hours after surgery | 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. |
| Duration of Surgery | The end of surgery | — |
| Tourniquet Use | The end of surgery | Number of participants who had a tourniquet during the surgery |
| Duration of Tourniquet | The end of surgery | The total time the tourniquet was left inflated |
| Procedure-related Pain on a Visual Analog Pain Scale | After the nerve block procedure ended, up to 5 minutes. | Pain was evaluated by the patient on a visual analog pain scale ranging from 0 (no pain) to 10 (worst pain of their life). |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| 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. | 112 |
| Total | 224 |
Baseline characteristics
| Characteristic | Ultrasound-guided Axillary Block | Total | Ultrasound-guided Infraclavicular Block |
|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 19 | 50 years STANDARD_DEVIATION 17 | 52 years STANDARD_DEVIATION 16 |
| American Society of Anesthesiologists (ASA) preoperative classification ASA 1 | 60 participants | 133 participants | 73 participants |
| American Society of Anesthesiologists (ASA) preoperative classification ASA 2 | 45 participants | 82 participants | 37 participants |
| American Society of Anesthesiologists (ASA) preoperative classification ASA 3 | 7 participants | 9 participants | 2 participants |
| Body mass index (BMI) | 26.4 kg/m^2 STANDARD_DEVIATION 4.1 | 25.8 kg/m^2 STANDARD_DEVIATION 4 | 25.3 kg/m^2 STANDARD_DEVIATION 3.8 |
| Diabetes | 4 participants | 13 participants | 9 participants |
| Sex: Female, Male Female | 40 Participants | 79 Participants | 39 Participants |
| Sex: Female, Male Male | 72 Participants | 145 Participants | 73 Participants |
| Site of surgery Elbow | 6 participants | 11 participants | 5 participants |
| Site of surgery Forearm | 2 participants | 6 participants | 4 participants |
| Site of surgery Hand | 79 participants | 159 participants | 80 participants |
| Site of surgery Wrist | 25 participants | 48 participants | 23 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 112 | 1 / 112 |
| serious Total, serious adverse events | 0 / 112 | 0 / 112 |
Outcome results
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.
Time frame: 30 minutes after block completion
Population: Statistical analyses were conducted according to the intention-to-treat principle
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrasound-guided Infraclavicular Block | Number of Patients With Complete Sensory Block | 91 percentage of participants |
| Ultrasound-guided Axillary Block | Number of Patients With Complete Sensory Block | 79 percentage of participants |
Duration of Surgery
Time frame: The end of surgery
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound-guided Infraclavicular Block | Duration of Surgery | 40 minutes |
| Ultrasound-guided Axillary Block | Duration of Surgery | 31 minutes |
Duration of Tourniquet
The total time the tourniquet was left inflated
Time frame: The end of surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound-guided Infraclavicular Block | Duration of Tourniquet | 37 minutes |
| Ultrasound-guided Axillary Block | Duration of Tourniquet | 31 minutes |
Number of Patients With Complete Motor Blocks
Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.
Time frame: 30 minutes after block completion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrasound-guided Infraclavicular Block | Number of Patients With Complete Motor Blocks | 71 percentage of participants |
| Ultrasound-guided Axillary Block | Number of Patients With Complete Motor Blocks | 54 percentage of participants |
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.
Time frame: 24 hours after surgery
Population: Four patients in the infraclavicular group and six in the axillary group could not be contacted in the pre-established time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrasound-guided Infraclavicular Block | Number of Patients With Postoperative Adverse Events Related to Nerve Block | 0 participants |
| Ultrasound-guided Axillary Block | Number of Patients With Postoperative Adverse Events Related to Nerve Block | 0 participants |
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.
Time frame: 1 month after surgery
Population: Eight patients in the infraclavicular group and five in the axillary group could not be contacted in the pre-established time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrasound-guided Infraclavicular Block | Number of Patients With Postoperative Adverse Events Related to Nerve Block | 0 participants |
| Ultrasound-guided Axillary Block | Number of Patients With Postoperative Adverse Events Related to Nerve Block | 0 participants |
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).
Time frame: During the performance of the block
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ultrasound-guided Infraclavicular Block | Performance Time of the Nerve Block | 231 seconds |
| Ultrasound-guided Axillary Block | Performance Time of the Nerve Block | 358 seconds |
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).
Time frame: After the nerve block procedure ended, up to 5 minutes.
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound-guided Infraclavicular Block | Procedure-related Pain on a Visual Analog Pain Scale | 2 units on a scale |
| Ultrasound-guided Axillary Block | Procedure-related Pain on a Visual Analog Pain Scale | 2 units on a scale |
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.
Time frame: End of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrasound-guided Infraclavicular Block | Surgical Block Success Rate | 93 percentage of participants |
| Ultrasound-guided Axillary Block | Surgical Block Success Rate | 82 percentage of participants |
Time to Complete Motor Block
Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories.
Time frame: 5, 10, 15, 20, 25 and 30 minutes after block completion
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultrasound-guided Infraclavicular Block | Time to Complete Motor Block | 5 minutes | 0 percentage of participants |
| Ultrasound-guided Infraclavicular Block | Time to Complete Motor Block | 10 minutes | 3.6 percentage of participants |
| Ultrasound-guided Infraclavicular Block | Time to Complete Motor Block | 15 minutes | 18 percentage of participants |
| Ultrasound-guided Infraclavicular Block | Time to Complete Motor Block | 20 minutes | 41 percentage of participants |
| Ultrasound-guided Infraclavicular Block | Time to Complete Motor Block | 25 minutes | 59 percentage of participants |
| Ultrasound-guided Infraclavicular Block | Time to Complete Motor Block | 30 minutes | 72 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Motor Block | 25 minutes | 37 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Motor Block | 5 minutes | 0 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Motor Block | 20 minutes | 29 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Motor Block | 10 minutes | 3.3 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Motor Block | 30 minutes | 53 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Motor Block | 15 minutes | 14 percentage of participants |
Time to Complete Sensory Block.
Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.
Time frame: 5, 10, 15, 20, 25 and 30 minutes after block completion
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultrasound-guided Infraclavicular Block | Time to Complete Sensory Block. | 5 minutes | 1.8 percentage of participants |
| Ultrasound-guided Infraclavicular Block | Time to Complete Sensory Block. | 10 minutes | 22 percentage of participants |
| Ultrasound-guided Infraclavicular Block | Time to Complete Sensory Block. | 15 minutes | 51 percentage of participants |
| Ultrasound-guided Infraclavicular Block | Time to Complete Sensory Block. | 20 minutes | 75 percentage of participants |
| Ultrasound-guided Infraclavicular Block | Time to Complete Sensory Block. | 25 minutes | 87 percentage of participants |
| Ultrasound-guided Infraclavicular Block | Time to Complete Sensory Block. | 30 minutes | 91 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Sensory Block. | 25 minutes | 70 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Sensory Block. | 5 minutes | 4 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Sensory Block. | 20 minutes | 56 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Sensory Block. | 10 minutes | 21 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Sensory Block. | 30 minutes | 79 percentage of participants |
| Ultrasound-guided Axillary Block | Time to Complete Sensory Block. | 15 minutes | 38 percentage of participants |
Tourniquet Use
Number of participants who had a tourniquet during the surgery
Time frame: The end of surgery
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ultrasound-guided Infraclavicular Block | Tourniquet Use | 84 participants |
| Ultrasound-guided Axillary Block | Tourniquet Use | 85 participants |