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Comparison of Ultrasound-Guided Infraclavicular Block and Ultrasound-Guided Axillary Block

Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Non-inferiority Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01761175
Enrollment
224
Registered
2013-01-04
Start date
2012-09-30
Completion date
2013-03-31
Last updated
2017-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

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.

PROCEDUREUltrasound-guided axillary block

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

CHU de Quebec-Universite Laval
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Number of Patients With Complete Sensory Block30 minutes after block completionComplete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.

Secondary

MeasureTime frameDescription
Time to Complete Sensory Block.5, 10, 15, 20, 25 and 30 minutes after block completionComplete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.
Time to Complete Motor Block5, 10, 15, 20, 25 and 30 minutes after block completionComplete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories.
Surgical Block Success RateEnd of surgerySurgical 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 BlockDuring the performance of the blockPerformance 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 Blocks30 minutes after block completionComplete 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 Block24 hours after surgeryAdverse 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 SurgeryThe end of surgery
Tourniquet UseThe end of surgeryNumber of participants who had a tourniquet during the surgery
Duration of TourniquetThe end of surgeryThe total time the tourniquet was left inflated
Procedure-related Pain on a Visual Analog Pain ScaleAfter 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

ArmCount
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
Total224

Baseline characteristics

CharacteristicUltrasound-guided Axillary BlockTotalUltrasound-guided Infraclavicular Block
Age, Continuous48 years
STANDARD_DEVIATION 19
50 years
STANDARD_DEVIATION 17
52 years
STANDARD_DEVIATION 16
American Society of Anesthesiologists (ASA) preoperative classification
ASA 1
60 participants133 participants73 participants
American Society of Anesthesiologists (ASA) preoperative classification
ASA 2
45 participants82 participants37 participants
American Society of Anesthesiologists (ASA) preoperative classification
ASA 3
7 participants9 participants2 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
Diabetes4 participants13 participants9 participants
Sex: Female, Male
Female
40 Participants79 Participants39 Participants
Sex: Female, Male
Male
72 Participants145 Participants73 Participants
Site of surgery
Elbow
6 participants11 participants5 participants
Site of surgery
Forearm
2 participants6 participants4 participants
Site of surgery
Hand
79 participants159 participants80 participants
Site of surgery
Wrist
25 participants48 participants23 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
3 / 1121 / 112
serious
Total, serious adverse events
0 / 1120 / 112

Outcome results

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.

Time frame: 30 minutes after block completion

Population: Statistical analyses were conducted according to the intention-to-treat principle

ArmMeasureValue (NUMBER)
Ultrasound-guided Infraclavicular BlockNumber of Patients With Complete Sensory Block91 percentage of participants
Ultrasound-guided Axillary BlockNumber of Patients With Complete Sensory Block79 percentage of participants
p-value: <0.01Chi-squared
Secondary

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.

ArmMeasureValue (MEDIAN)
Ultrasound-guided Infraclavicular BlockDuration of Surgery40 minutes
Ultrasound-guided Axillary BlockDuration of Surgery31 minutes
Secondary

Duration of Tourniquet

The total time the tourniquet was left inflated

Time frame: The end of surgery

ArmMeasureValue (MEDIAN)
Ultrasound-guided Infraclavicular BlockDuration of Tourniquet37 minutes
Ultrasound-guided Axillary BlockDuration of Tourniquet31 minutes
Secondary

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

ArmMeasureValue (NUMBER)
Ultrasound-guided Infraclavicular BlockNumber of Patients With Complete Motor Blocks71 percentage of participants
Ultrasound-guided Axillary BlockNumber of Patients With Complete Motor Blocks54 percentage of participants
p-value: <0.01Chi-squared
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.

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.

ArmMeasureValue (NUMBER)
Ultrasound-guided Infraclavicular BlockNumber of Patients With Postoperative Adverse Events Related to Nerve Block0 participants
Ultrasound-guided Axillary BlockNumber of Patients With Postoperative Adverse Events Related to Nerve Block0 participants
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.

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.

ArmMeasureValue (NUMBER)
Ultrasound-guided Infraclavicular BlockNumber of Patients With Postoperative Adverse Events Related to Nerve Block0 participants
Ultrasound-guided Axillary BlockNumber of Patients With Postoperative Adverse Events Related to Nerve Block0 participants
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).

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.

ArmMeasureValue (MEAN)
Ultrasound-guided Infraclavicular BlockPerformance Time of the Nerve Block231 seconds
Ultrasound-guided Axillary BlockPerformance Time of the Nerve Block358 seconds
p-value: <0.01Wilcoxon (Mann-Whitney)
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).

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.

ArmMeasureValue (MEDIAN)
Ultrasound-guided Infraclavicular BlockProcedure-related Pain on a Visual Analog Pain Scale2 units on a scale
Ultrasound-guided Axillary BlockProcedure-related Pain on a Visual Analog Pain Scale2 units on a scale
p-value: 0.34Wilcoxon (Mann-Whitney)
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.

Time frame: End of surgery

ArmMeasureValue (NUMBER)
Ultrasound-guided Infraclavicular BlockSurgical Block Success Rate93 percentage of participants
Ultrasound-guided Axillary BlockSurgical Block Success Rate82 percentage of participants
p-value: 0.02Chi-squared
Secondary

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.

ArmMeasureGroupValue (NUMBER)
Ultrasound-guided Infraclavicular BlockTime to Complete Motor Block5 minutes0 percentage of participants
Ultrasound-guided Infraclavicular BlockTime to Complete Motor Block10 minutes3.6 percentage of participants
Ultrasound-guided Infraclavicular BlockTime to Complete Motor Block15 minutes18 percentage of participants
Ultrasound-guided Infraclavicular BlockTime to Complete Motor Block20 minutes41 percentage of participants
Ultrasound-guided Infraclavicular BlockTime to Complete Motor Block25 minutes59 percentage of participants
Ultrasound-guided Infraclavicular BlockTime to Complete Motor Block30 minutes72 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Motor Block25 minutes37 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Motor Block5 minutes0 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Motor Block20 minutes29 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Motor Block10 minutes3.3 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Motor Block30 minutes53 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Motor Block15 minutes14 percentage of participants
p-value: <0.01Log Rank
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.

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.

ArmMeasureGroupValue (NUMBER)
Ultrasound-guided Infraclavicular BlockTime to Complete Sensory Block.5 minutes1.8 percentage of participants
Ultrasound-guided Infraclavicular BlockTime to Complete Sensory Block.10 minutes22 percentage of participants
Ultrasound-guided Infraclavicular BlockTime to Complete Sensory Block.15 minutes51 percentage of participants
Ultrasound-guided Infraclavicular BlockTime to Complete Sensory Block.20 minutes75 percentage of participants
Ultrasound-guided Infraclavicular BlockTime to Complete Sensory Block.25 minutes87 percentage of participants
Ultrasound-guided Infraclavicular BlockTime to Complete Sensory Block.30 minutes91 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Sensory Block.25 minutes70 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Sensory Block.5 minutes4 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Sensory Block.20 minutes56 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Sensory Block.10 minutes21 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Sensory Block.30 minutes79 percentage of participants
Ultrasound-guided Axillary BlockTime to Complete Sensory Block.15 minutes38 percentage of participants
p-value: <0.01Log Rank
Secondary

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.

ArmMeasureValue (NUMBER)
Ultrasound-guided Infraclavicular BlockTourniquet Use84 participants
Ultrasound-guided Axillary BlockTourniquet Use85 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026