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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: Ultrasound-guided infraclavicular block
* Procedure: Ultrasound-guided axillary block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older American Society of Anesthesiologists Class 1 to 3 Undergoing a surgery at the elbow, forearm, wrist or hand under regional anesthesia Exclusion Criteria: Age less than 18 years Body mass index more than 40 kg/m2 Weight less than 45 kg Patient refusal Contraindication to regional anesthesia (coagulopathy, local infection at the puncture site, systemic infection) Previous neurological deficit in the operated arm Severe renal or hepatic failure Prior surgery in the axillary or infraclavicular area Pregnancy or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound-guided infraclavicular block<br>Ultrasound-guided single injection infraclavicular block | Procedure: Ultrasound-guided infraclavicular block<br>* 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.<br>|
| Active Comparator: Ultrasound-guided axillary block<br>Ultrasound-guided double injection axillary block | Procedure: Ultrasound-guided axillary block<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 minutes after block completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Complete Motor Blocks | Complete motor block is defined by paralysis in the ulnar, radial, median and musculocutaneous nerves territories. | 30 minutes after block completion | 
| Time to Complete Sensory Block. | Complete sensory block is defined by anesthesia to cold sensation in the median, ulnar, radial and musculocutaneous nerves territories. | 5, 10, 15, 20, 25 and 30 minutes after block completion | 
| Time to Complete Motor Block | Complete motor block is defined by paralysis in the median, ulnar, radial and musculocutaneous nerves territories. | 5, 10, 15, 20, 25 and 30 minutes after block completion | 
| 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. | End of surgery | 
| 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). | During the performance of the block | 
| 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). | After the nerve block procedure ended, up to 5 minutes. | 
| 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. | 24 hours after surgery | 
| 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. | 1 month after surgery | 
| Duration of Surgery |  | The end of surgery | 
| Tourniquet Use | Number of participants who had a tourniquet during the surgery | The end of surgery | 
| Duration of Tourniquet | The total time the tourniquet was left inflated | The end of surgery |