Prospective Randomized Clinical Trial Comparing Infraclavicular Versus Axillary Approach to Brachial Plexus Block.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- postoperative analgesia
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ultrasound: Axillary block
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.
Intervention: Ropivacaine (Drug)
Ultrasound: Infraclavicular block
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.
Intervention: Ropivacaine (Drug)
Outcomes
Primary Outcomes
postoperative analgesia
Time Frame: first postoperative day
All patients will be contacted on the first postoperative day to tell the time of onset of pain postoperatively. The duration of postoperative analgesia is defined as the interval between the end of local anesthetic injection and the onset of postoperative pain reported by the patient.
Secondary Outcomes
- local anesthetic pharmacokinetics(During the procedure)
Investigators
Leonardo Henrique Cunha Ferraro
MD
Federal University of São Paulo