Trial Outcomes & Findings for Comparison of Ultrasound-Guided Infraclavicular Block and Ultrasound-Guided Axillary Block (NCT NCT01761175)
NCT ID: NCT01761175
Last Updated: 2017-08-04
Results Overview
Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.
COMPLETED
NA
224 participants
30 minutes after block completion
2017-08-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
112
|
112
|
|
Overall Study
COMPLETED
|
112
|
112
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Ultrasound-Guided Infraclavicular Block and Ultrasound-Guided Axillary Block
Baseline characteristics by cohort
| Measure |
Ultrasound-guided Infraclavicular Block
n=112 Participants
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 Axillary Block
n=112 Participants
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
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 16 • n=5 Participants
|
48 years
STANDARD_DEVIATION 19 • n=7 Participants
|
50 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Body mass index (BMI)
|
25.3 kg/m^2
STANDARD_DEVIATION 3.8 • n=5 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 4.1 • n=7 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Diabetes
|
9 participants
n=5 Participants
|
4 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) preoperative classification
ASA 1
|
73 participants
n=5 Participants
|
60 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) preoperative classification
ASA 2
|
37 participants
n=5 Participants
|
45 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) preoperative classification
ASA 3
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Site of surgery
Hand
|
80 participants
n=5 Participants
|
79 participants
n=7 Participants
|
159 participants
n=5 Participants
|
|
Site of surgery
Wrist
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Site of surgery
Forearm
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Site of surgery
Elbow
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after block completionPopulation: Statistical analyses were conducted according to the intention-to-treat principle
Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=112 Participants
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 Axillary Block
n=112 Participants
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.
|
|---|---|---|
|
Number of Patients With Complete Sensory Block
|
91 percentage of participants
Interval 85.0 to 95.0
|
79 percentage of participants
Interval 71.0 to 85.0
|
SECONDARY outcome
Timeframe: 30 minutes after block completionComplete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=112 Participants
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 Axillary Block
n=112 Participants
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.
|
|---|---|---|
|
Number of Patients With Complete Motor Blocks
|
71 percentage of participants
Interval 61.0 to 79.0
|
54 percentage of participants
Interval 44.0 to 63.0
|
SECONDARY outcome
Timeframe: 5, 10, 15, 20, 25 and 30 minutes after block completionPopulation: 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.
Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=111 Participants
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 Axillary Block
n=112 Participants
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.
|
|---|---|---|
|
Time to Complete Sensory Block.
5 minutes
|
1.8 percentage of participants
Interval 0.5 to 7.1
|
4 percentage of participants
Interval 1.6 to 9.5
|
|
Time to Complete Sensory Block.
10 minutes
|
22 percentage of participants
Interval 15.0 to 31.0
|
21 percentage of participants
Interval 14.0 to 30.0
|
|
Time to Complete Sensory Block.
15 minutes
|
51 percentage of participants
Interval 43.0 to 62.0
|
38 percentage of participants
Interval 30.0 to 49.0
|
|
Time to Complete Sensory Block.
20 minutes
|
75 percentage of participants
Interval 67.0 to 83.0
|
56 percentage of participants
Interval 48.0 to 66.0
|
|
Time to Complete Sensory Block.
25 minutes
|
87 percentage of participants
Interval 81.0 to 94.0
|
70 percentage of participants
Interval 62.0 to 79.0
|
|
Time to Complete Sensory Block.
30 minutes
|
91 percentage of participants
Interval 84.0 to 95.0
|
79 percentage of participants
Interval 70.0 to 85.0
|
SECONDARY outcome
Timeframe: 5, 10, 15, 20, 25 and 30 minutes after block completionPopulation: 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.
Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories.
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=111 Participants
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 Axillary Block
n=112 Participants
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.
|
|---|---|---|
|
Time to Complete Motor Block
5 minutes
|
0 percentage of participants
Interval 0.0 to 0.0
|
0 percentage of participants
Interval 0.0 to 0.0
|
|
Time to Complete Motor Block
10 minutes
|
3.6 percentage of participants
Interval 1.4 to 9.4
|
3.3 percentage of participants
Interval 1.4 to 7.8
|
|
Time to Complete Motor Block
15 minutes
|
18 percentage of participants
Interval 12.0 to 27.0
|
14 percentage of participants
Interval 9.0 to 22.0
|
|
Time to Complete Motor Block
20 minutes
|
41 percentage of participants
Interval 32.0 to 51.0
|
29 percentage of participants
Interval 21.0 to 38.0
|
|
Time to Complete Motor Block
25 minutes
|
59 percentage of participants
Interval 50.0 to 68.0
|
37 percentage of participants
Interval 29.0 to 47.0
|
|
Time to Complete Motor Block
30 minutes
|
72 percentage of participants
Interval 63.0 to 80.0
|
53 percentage of participants
Interval 45.0 to 63.0
|
SECONDARY outcome
Timeframe: End 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.
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=112 Participants
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 Axillary Block
n=112 Participants
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.
|
|---|---|---|
|
Surgical Block Success Rate
|
93 percentage of participants
Interval 86.0 to 97.0
|
82 percentage of participants
Interval 74.0 to 89.0
|
SECONDARY outcome
Timeframe: During the performance of the blockPopulation: 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.
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).
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=111 Participants
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 Axillary Block
n=112 Participants
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.
|
|---|---|---|
|
Performance Time of the Nerve Block
|
231 seconds
Interval 213.0 to 250.0
|
358 seconds
Interval 332.0 to 387.0
|
SECONDARY outcome
Timeframe: 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.
Pain was evaluated by the patient on a visual analog pain scale ranging from 0 (no pain) to 10 (worst pain of their life).
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=109 Participants
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 Axillary Block
n=111 Participants
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.
|
|---|---|---|
|
Procedure-related Pain on a Visual Analog Pain Scale
|
2 units on a scale
Interval 1.0 to 4.0
|
2 units on a scale
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: 24 hours after surgeryPopulation: Four patients in the infraclavicular group and six in the axillary group could not be contacted in the pre-established time frame.
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.
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=108 Participants
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 Axillary Block
n=106 Participants
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.
|
|---|---|---|
|
Number of Patients With Postoperative Adverse Events Related to Nerve Block
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 month after surgeryPopulation: Eight patients in the infraclavicular group and five in the axillary group could not be contacted in the pre-established time frame.
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.
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=104 Participants
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 Axillary Block
n=107 Participants
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.
|
|---|---|---|
|
Number of Patients With Postoperative Adverse Events Related to Nerve Block
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: The end of surgeryPopulation: 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.
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=111 Participants
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 Axillary Block
n=112 Participants
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.
|
|---|---|---|
|
Duration of Surgery
|
40 minutes
Interval 20.0 to 55.0
|
31 minutes
Interval 15.0 to 55.0
|
SECONDARY outcome
Timeframe: The end of surgeryPopulation: 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.
Number of participants who had a tourniquet during the surgery
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=111 Participants
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 Axillary Block
n=112 Participants
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.
|
|---|---|---|
|
Tourniquet Use
|
84 participants
|
85 participants
|
SECONDARY outcome
Timeframe: The end of surgeryThe total time the tourniquet was left inflated
Outcome measures
| Measure |
Ultrasound-guided Infraclavicular Block
n=84 Participants
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 Axillary Block
n=85 Participants
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.
|
|---|---|---|
|
Duration of Tourniquet
|
37 minutes
Interval 27.0 to 49.0
|
31 minutes
Interval 18.0 to 50.0
|
Adverse Events
Ultrasound-guided Infraclavicular Block
Ultrasound-guided Axillary Block
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ultrasound-guided Infraclavicular Block
n=112 participants at risk
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 Axillary Block
n=112 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Local anesthetic toxicity
|
0.00%
0/112 • 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.
|
0.89%
1/112 • Number of events 1 • 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.
|
|
Nervous system disorders
Horner syndrome
|
1.8%
2/112 • Number of events 2 • 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.
|
0.00%
0/112 • 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.
|
|
Skin and subcutaneous tissue disorders
Hematoma
|
0.89%
1/112 • Number of events 1 • 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.
|
0.00%
0/112 • 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.
|
Additional Information
Dre Marie-Josée Nadeau
CHU de Québec, Département d'Anesthésie-Réanimation de l'Hôpital de l'Enfant-Jésus
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place