Clinical trial NCT01761175: Comparison of Ultrasound-Guided Infraclavicular Block and Ultrasound-Guided Axillary Block
Official title: Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Non-inferiority Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients With Complete Sensory Block
timeFrame: 30 minutes after block completion
Secondary outcomes:
measure: Number of Patients With Complete Motor Blocks
timeFrame: 30 minutes after block completion
measure: Time to Complete Sensory Block.
timeFrame: 5, 10, 15, 20, 25 and 30 minutes after block completion
measure: Time to Complete Motor Block
timeFrame: 5, 10, 15, 20, 25 and 30 minutes after block completion
measure: Surgical Block Success Rate
timeFrame: End of surgery
measure: Performance Time of the Nerve Block
timeFrame: During the performance of the block
measure: Procedure-related Pain on a Visual Analog Pain Scale
timeFrame: After the nerve block procedure ended, up to 5 minutes.
measure: Number of Patients With Postoperative Adverse Events Related to Nerve Block
timeFrame: 24 hours after surgery
measure: Number of Patients With Postoperative Adverse Events Related to Nerve Block
timeFrame: 1 month after surgery
measure: Duration of Surgery
timeFrame: The end of surgery
measure: Tourniquet Use
timeFrame: The end of surgery
measure: Duration of Tourniquet
timeFrame: The end of surgery
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Hôpital de l'Enfant-Jésus
city: Québec
country: Canada
facility: Hôpital de Saint-Sacrement
Study officials:
affiliation: CHU de Québec
name: Ariane Boivin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Québec
name: Marie-Josée Nadeau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Québec
name: Nicolas Dion, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Québec
name: Simon Lévesque, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Québec
name: Pierre C. Nicole, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Québec
name: Alexis F. Turgeon, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.