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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

224 participants

Primary outcome timeframe

30 minutes after block completion

Results posted on

2017-08-04

Participant Flow

Participant milestones

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

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 completion

Population: 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

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 completion

Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories.

Outcome measures

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 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.

Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories.

Outcome measures

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 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.

Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories.

Outcome measures

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 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.

Outcome measures

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 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.

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

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

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 surgery

Population: 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

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 surgery

Population: 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

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 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.

Outcome measures

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 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.

Number of participants who had a tourniquet during the surgery

Outcome measures

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 surgery

The total time the tourniquet was left inflated

Outcome measures

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

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Ultrasound-guided Axillary Block

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Phone: 418 649-5807

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place