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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01761175
Recruitment Status : Completed
First Posted : January 4, 2013
Results First Posted : August 4, 2017
Last Update Posted : August 4, 2017
Sponsor:
Information provided by (Responsible Party):
Ariane Boivin, CHU de Quebec-Universite Laval

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Anesthesia
Interventions Procedure: Ultrasound-guided infraclavicular block
Procedure: Ultrasound-guided axillary block
Enrollment 224
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 112 112
Completed 112 112
Not Completed 0 0
Arm/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 112 112 224
Hide Baseline Analysis Population Description
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  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 112 participants 224 participants
52  (16) 48  (19) 50  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 112 participants 224 participants
Female
39
  34.8%
40
  35.7%
79
  35.3%
Male
73
  65.2%
72
  64.3%
145
  64.7%
Body mass index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 112 participants 112 participants 224 participants
25.3  (3.8) 26.4  (4.1) 25.8  (4.0)
Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants 112 participants 224 participants
9 4 13
American Society of Anesthesiologists (ASA) preoperative classification   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants 112 participants 224 participants
ASA 1 73 60 133
ASA 2 37 45 82
ASA 3 2 7 9
[1]
Measure Description: 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
Site of surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 112 participants 112 participants 224 participants
Hand 80 79 159
Wrist 23 25 48
Forearm 4 2 6
Elbow 5 6 11
1.Primary Outcome
Title Number of Patients With Complete Sensory Block
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Statistical analyses were conducted according to the intention-to-treat principle
Arm/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 112 112
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
91
(85 to 95)
79
(71 to 85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultrasound-guided Infraclavicular Block, Ultrasound-guided Axillary Block
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Number of Patients With Complete Motor Blocks
Hide Description Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.
Time Frame 30 minutes after block completion
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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 looking for a crescent shape distribution around the artery.

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.

Overall Number of Participants Analyzed 112 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
71
(61 to 79)
54
(44 to 63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultrasound-guided Infraclavicular Block, Ultrasound-guided Axillary Block
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Time to Complete Sensory Block.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 111 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5 minutes
1.8
(0.5 to 7.1)
4
(1.6 to 9.5)
10 minutes
22
(15 to 31)
21
(14 to 30)
15 minutes
51
(43 to 62)
38
(30 to 49)
20 minutes
75
(67 to 83)
56
(48 to 66)
25 minutes
87
(81 to 94)
70
(62 to 79)
30 minutes
91
(84 to 95)
79
(70 to 85)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultrasound-guided Infraclavicular Block, Ultrasound-guided Axillary Block
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Time to Complete Motor Block
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 111 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5 minutes
0
(0 to 0)
0
(0 to 0)
10 minutes
3.6
(1.4 to 9.4)
3.3
(1.4 to 7.8)
15 minutes
18
(12 to 27)
14
(9 to 22)
20 minutes
41
(32 to 51)
29
(21 to 38)
25 minutes
59
(50 to 68)
37
(29 to 47)
30 minutes
72
(63 to 80)
53
(45 to 63)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultrasound-guided Infraclavicular Block, Ultrasound-guided Axillary Block
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title Surgical Block Success Rate
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 112 112
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93
(86 to 97)
82
(74 to 89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultrasound-guided Infraclavicular Block, Ultrasound-guided Axillary Block
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title Performance Time of the Nerve Block
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 111 112
Mean (95% Confidence Interval)
Unit of Measure: seconds
231
(213 to 250)
358
(332 to 387)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultrasound-guided Infraclavicular Block, Ultrasound-guided Axillary Block
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Procedure-related Pain on a Visual Analog Pain Scale
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 109 111
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
2
(1 to 4)
2
(1 to 4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ultrasound-guided Infraclavicular Block, Ultrasound-guided Axillary Block
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Number of Patients With Postoperative Adverse Events Related to Nerve Block
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Four patients in the infraclavicular group and six in the axillary group could not be contacted in the pre-established time frame.
Arm/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 108 106
Measure Type: Number
Unit of Measure: participants
0 0
9.Secondary Outcome
Title Number of Patients With Postoperative Adverse Events Related to Nerve Block
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Eight patients in the infraclavicular group and five in the axillary group could not be contacted in the pre-established time frame.
Arm/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 104 107
Measure Type: Number
Unit of Measure: participants
0 0
10.Secondary Outcome
Title Duration of Surgery
Hide Description [Not Specified]
Time Frame The end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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 looking for a crescent shape distribution around the artery.

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.

Overall Number of Participants Analyzed 111 112
Median (Inter-Quartile Range)
Unit of Measure: minutes
40
(20 to 55)
31
(15 to 55)
11.Secondary Outcome
Title Tourniquet Use
Hide Description Number of participants who had a tourniquet during the surgery
Time Frame The end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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 looking for a crescent shape distribution around the artery.

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.

Overall Number of Participants Analyzed 111 112
Measure Type: Number
Unit of Measure: participants
84 85
12.Secondary Outcome
Title Duration of Tourniquet
Hide Description The total time the tourniquet was left inflated
Time Frame The end of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description:

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 looking for a crescent shape distribution around the artery.

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.

Overall Number of Participants Analyzed 84 85
Median (Inter-Quartile Range)
Unit of Measure: minutes
37
(27 to 49)
31
(18 to 50)
Time Frame 1 month
Adverse Event Reporting Description 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.
 
Arm/Group Title Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/112 (0.00%)      0/112 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ultrasound-guided Infraclavicular Block Ultrasound-guided Axillary Block
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/112 (2.68%)      1/112 (0.89%)    
Nervous system disorders     
Local anesthetic toxicity  [1]  0/112 (0.00%)  0 1/112 (0.89%)  1
Horner syndrome * [2]  2/112 (1.79%)  2 0/112 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hematoma  [3]  1/112 (0.89%)  1 0/112 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Mild signs of local anesthetic toxicity including tinnitus, circumoral numbness, drowsiness, lightheadedness or metallic taste.
[2]
Ptosis, miosis, and anhidrosis of the side of the face ipsilateral to the block performed
[3]
Hematoma at the puncture site
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dre Marie-Josée Nadeau
Organization: CHU de Québec, Département d'Anesthésie-Réanimation de l'Hôpital de l'Enfant-Jésus
Phone: 418 649-5807
EMail: marie-josee.nadeau@fmed.ulaval.ca
Layout table for additonal information
Responsible Party: Ariane Boivin, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT01761175    
Other Study ID Numbers: PEJ-666
First Submitted: January 3, 2013
First Posted: January 4, 2013
Results First Submitted: March 28, 2014
Results First Posted: August 4, 2017
Last Update Posted: August 4, 2017