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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Ultrasound-guided infraclavicular block; Procedure: Ultrasound-guided axillary block

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound-guided infraclavicular block; Ultrasound-guided single injection infraclavicular block	Procedure: 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.
Active Comparator: Ultrasound-guided axillary block; Ultrasound-guided double injection axillary block	Procedure: Ultrasound-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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Investigators: Principal Investigator: Ariane Boivin, MD, CHU de Québec; Principal Investigator: Marie-Josée Nadeau, MD, CHU de Québec; Principal Investigator: Nicolas Dion, MD, CHU de Québec; Principal Investigator: Simon Lévesque, MD, CHU de Québec; Principal Investigator: Pierre C. Nicole, MD, CHU de Québec; Principal Investigator: Alexis F. Turgeon, MD, Msc, CHU de Québec

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: January 3, 2013
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimate): January 4, 2013

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: PEJ-666