This trial is active, not recruiting.

Conditions scaphoid fractures, distal radius fractures, wrist injury arthrodesis
Treatments ultrasound: axillary block, ultrasound: infraclavicular block, ropivacaine
Sponsor Federal University of São Paulo
Start date February 2014
End date March 2015
Trial size 46 participants
Trial identifier NCT02208245, Infra Study


The brachial plexus block is an anesthetic technique often used for surgical procedures of the upper limb. To get the brachial plexus block, several routes can be used, including the axillary and infraclavicular approach.

Few studies have compared these techniques, considering the time to perform the block, the onset time and success rate, with conflicting results. Furthermore, there is little information in the literature comparing the length of postoperative analgesia provided by these techniques.

Therefore, the investigators designed this study in order to elucidate the differences between these two techniques to assist the anesthesiologist to choose the best of them in clinical practice.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
For the axillary group, the ultrasound probe will be placed upright in the armpit to obtain a cross section of this region. After visualization of the nerves form the brachial plexus by ultrasound, 5 mL of ropivacaine 0.5% will be injected around each nerve to be blocked (median, ulnar, radial and musculocutaneous). If resistance to the injection of the solution is present or the patient complains of severe pain, the needle will be immediately repositioned.
ultrasound: axillary block
Ultrasound guided axillary block
20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)
(Active Comparator)
For the infraclavicular group, the ultrasound probe will be placed in the infraclavicular region (the junction between the clavicle and the coracoid process) to obtain a cross-sectional imaging of the axillary artery. After visualization of the axillary artery by ultrasound, the block will be performed using the technique in plan for visualization of the needle. The needle is placed in position 6-8 hours of the artery, and 20 mL of ropivacaine 0.5% will be injected, observing a dispersal of local anesthetic around the artery.
ultrasound: infraclavicular block
Ultrasound guided infraclvicular block
20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)

Primary Outcomes

postoperative analgesia
time frame: first postoperative day

Secondary Outcomes

local anesthetic pharmacokinetics
time frame: During the procedure

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - age older than 18 years and less than 70 years - consent informed signed by the patient - candidates for surgical intervention of scaphoid fractures, distal radius fractures and wrist arthrodesis - American Society of Anesthesiology physical status I, II and III - body mass index (BMI) <35 kg / m². Exclusion Criteria: - cognitive impairment or active psychiatric condition - infection at the puncture site - bleeding disorders - history of allergy to ropivacaine

Additional Information

Official title Prospective Randomized Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Federal University of São Paulo.