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CompletedNCT01761175Updated Aug 4, 2017Results posted

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

An interventional study of Ultrasound-guided infraclavicular block and Ultrasound-guided axillary block in Anesthesia, sponsored by CHU de Quebec-Universite Laval. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-04.

Sponsored by CHU de Quebec-Universite Laval · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

CHU de Quebec-Universite Laval is the lead sponsor of 134 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
224 participants (actual)

Study arms

  • Active comparator
    Ultrasound-guided infraclavicular block

    Ultrasound-guided single injection infraclavicular block

    Procedure: Ultrasound-guided infraclavicular block

  • Active comparator
    Ultrasound-guided axillary block

    Ultrasound-guided double injection axillary block

    Procedure: Ultrasound-guided axillary block

Interventions

  • ProcedureUltrasound-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.

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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

  9. Duration of Surgery

    Time frame: The end of surgery

  10. Tourniquet Use

    Number of participants who had a tourniquet during the surgery

    Time frame: The end of surgery

  11. Duration of Tourniquet

    The total time the tourniquet was left inflated

    Time frame: The end of surgery

07

Results

Posted Aug 4, 2017

Participant flow

Participant flow — Overall Study
MilestoneUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Started112112
Completed112112
Not completed00

Outcome measures

PrimaryNumber 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
Reported as:
Number · percentage of participants
Number of Patients With Complete Sensory Block
percentage of participantsUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Number of Patients With Complete Sensory Block91 (85 to 95)79 (71 to 85)
Statistical analysis
  • Ultrasound-guided Infraclavicular Block vs Ultrasound-guided Axillary Block · Chi-squared · p = <0.01
SecondaryNumber 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
Reported as:
Number · percentage of participants
Number of Patients With Complete Motor Blocks
percentage of participantsUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Number of Patients With Complete Motor Blocks71 (61 to 79)54 (44 to 63)
Statistical analysis
  • Ultrasound-guided Infraclavicular Block vs Ultrasound-guided Axillary Block · Chi-squared · p = <0.01
SecondaryTime 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
Reported as:
Number · percentage of participants
Time to Complete Sensory Block.
percentage of participantsUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
5 minutes1.8 (0.5 to 7.1)4 (1.6 to 9.5)
10 minutes22 (15 to 31)21 (14 to 30)
15 minutes51 (43 to 62)38 (30 to 49)
20 minutes75 (67 to 83)56 (48 to 66)
25 minutes87 (81 to 94)70 (62 to 79)
30 minutes91 (84 to 95)79 (70 to 85)
Statistical analysis
  • Ultrasound-guided Infraclavicular Block vs Ultrasound-guided Axillary Block · Log Rank · p = <0.01
SecondaryTime 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
Reported as:
Number · percentage of participants
Time to Complete Motor Block
percentage of participantsUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
5 minutes0 (0 to 0)0 (0 to 0)
10 minutes3.6 (1.4 to 9.4)3.3 (1.4 to 7.8)
15 minutes18 (12 to 27)14 (9 to 22)
20 minutes41 (32 to 51)29 (21 to 38)
25 minutes59 (50 to 68)37 (29 to 47)
30 minutes72 (63 to 80)53 (45 to 63)
Statistical analysis
  • Ultrasound-guided Infraclavicular Block vs Ultrasound-guided Axillary Block · Log Rank · p = <0.01
SecondarySurgical 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
Reported as:
Number · percentage of participants
Surgical Block Success Rate
percentage of participantsUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Surgical Block Success Rate93 (86 to 97)82 (74 to 89)
Statistical analysis
  • Ultrasound-guided Infraclavicular Block vs Ultrasound-guided Axillary Block · Chi-squared · p = 0.02
SecondaryPerformance 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
Reported as:
Mean · seconds
Performance Time of the Nerve Block
secondsUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Performance Time of the Nerve Block231 (213 to 250)358 (332 to 387)
Statistical analysis
  • Ultrasound-guided Infraclavicular Block vs Ultrasound-guided Axillary Block · Wilcoxon (Mann-Whitney) · p = <0.01
SecondaryProcedure-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.
Reported as:
Median · units on a scale
Procedure-related Pain on a Visual Analog Pain Scale
units on a scaleUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Procedure-related Pain on a Visual Analog Pain Scale2 (1 to 4)2 (1 to 4)
Statistical analysis
  • Ultrasound-guided Infraclavicular Block vs Ultrasound-guided Axillary Block · Wilcoxon (Mann-Whitney) · p = 0.34
SecondaryNumber 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
Reported as:
Number · participants
Number of Patients With Postoperative Adverse Events Related to Nerve Block
participantsUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Number of Patients With Postoperative Adverse Events Related to Nerve Block00
SecondaryNumber 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
Reported as:
Number · participants
Number of Patients With Postoperative Adverse Events Related to Nerve Block
participantsUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Number of Patients With Postoperative Adverse Events Related to Nerve Block00
SecondaryDuration of Surgery
Time frame:
The end of surgery
Reported as:
Median · minutes
Duration of Surgery
minutesUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Duration of Surgery40 (20 to 55)31 (15 to 55)
SecondaryTourniquet Use

Number of participants who had a tourniquet during the surgery

Time frame:
The end of surgery
Reported as:
Number · participants
Tourniquet Use
participantsUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Tourniquet Use8485
SecondaryDuration of Tourniquet

The total time the tourniquet was left inflated

Time frame:
The end of surgery
Reported as:
Median · minutes
Duration of Tourniquet
minutesUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Duration of Tourniquet37 (27 to 49)31 (18 to 50)

Adverse events

Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ultrasound-guided Infraclavicular Block—0/112 (0%)3/112 (2.7%)
Ultrasound-guided Axillary Block—0/112 (0%)1/112 (0.9%)
Most frequent other events
Most frequent other events
EventUltrasound-guided Infraclavicular BlockUltrasound-guided Axillary Block
Horner syndromeNervous system disorders2/1120/112
Local anesthetic toxicityNervous system disorders0/1121/112
HematomaSkin and subcutaneous tissue disorders1/1120/112

Baseline characteristics

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).

Age, Continuous
Age, Continuous(years)Ultrasound-guided Infraclavicular BlockUltrasound-guided Axillary BlockTotal
Mean52 ± 1648 ± 1950 ± 17
Sex: Female, Male
Sex: Female, Male(Participants)Ultrasound-guided Infraclavicular BlockUltrasound-guided Axillary BlockTotal
Female394079
Male7372145
Body mass index (BMI)
Body mass index (BMI)(kg/m^2)Ultrasound-guided Infraclavicular BlockUltrasound-guided Axillary BlockTotal
Mean25.3 ± 3.826.4 ± 4.125.8 ± 4.0
Diabetes
Diabetes(participants)Ultrasound-guided Infraclavicular BlockUltrasound-guided Axillary BlockTotal
Number9413
American Society of Anesthesiologists (ASA) preoperative classification
American Society of Anesthesiologists (ASA) preoperative classification(participants)Ultrasound-guided Infraclavicular BlockUltrasound-guided Axillary BlockTotal
ASA 17360133
ASA 2374582
ASA 3279
Site of surgery
Site of surgery(participants)Ultrasound-guided Infraclavicular BlockUltrasound-guided Axillary BlockTotal
Hand8079159
Wrist232548
Forearm426
Elbow5611
08

Study locations

2 sites
  • Hôpital de l'Enfant-Jésus
    Québec, G1J 1Z4, Canada
  • Hôpital de Saint-Sacrement
    Québec, G1S 4L8, Canada
09

References and documents

Publications

  • 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. PubMed 26516803 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01761175
Lead sponsor
CHU de Quebec-Universite Laval
Responsible party
Ariane Boivin (MD, CHU de Quebec-Universite Laval) — Principal investigator
First posted
Jan 4, 2013
Start date
Sep 2012
Primary completion
Feb 2013
Completion
Mar 2013
Results posted
Aug 4, 2017
Last update
Aug 4, 2017

Study contacts

Ariane Boivin, MD
principal investigator · CHU de Québec
Marie-Josée Nadeau, MD
principal investigator · CHU de Québec
Nicolas Dion, MD
principal investigator · CHU de Québec
Simon Lévesque, MD
principal investigator · CHU de Québec
Pierre C. Nicole, MD
principal investigator · CHU de Québec
Alexis F. Turgeon, MD, Msc
principal investigator · CHU de Québec

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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