Clinical trial NCT01852396: The Retroclavicular Approach for Regional Anesthesia
Official title: Ultrasound-Guided Brachial Plexus Regional Anesthesia by the Novel Retroclavicular Approach : A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Describe Novel Approach to Brachial Plexus Anesthesia
Keywords: Infraclavicular block
Brachial Plexus
Retroclavicular Approach
Complications of retroclavicular approach
Success of retroclavicular approach
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to demonstrate that the novel retroclavicular approach is a safe, fast and effective technique for ultrasound-guided brachial plexus anesthesia.

Detailed description: Classic infraclavicular approach of the brachial plexus involves a needle puncture below the clavicle and advancing the needle with a 45-60 degree angle from cephalad to caudad. The aim is to advanced the block needle posterior to the axillary artery and to deposit the local anesthetic at that point, near the posterior cord. A "U" shaped spread around the artery should ensure distribution around all three cords. Ultrasound guidance is highly recommended and neurostimulation is optional.

The retroclavicular approach is a variant to this classical technique. Ultrasound probe is positioned initially below the clavicle in a manner similar to the classic approach but is then rotated in a clockwise fashion (right arm) or counter-clockwise fashion (left arm) for about 25-35 degrees. The puncture site is just behind the clavicle at the most lateral point available. If initial entry point is optimal, needle direction is then parallel to ultrasound probe. The final aim and position of block needle is identical to classical approach. Entry point ensures a parallel alignment of the needle and the ultrasound beam, thus enabling almost perfect visualization of both artery, cords and block needle. This is turn optimizes safety, rapidity of technique, efficiency and efficacy.

Eligibility criteria: Inclusion Criteria:

* Elective or Urgent Surgery of the hand, wrist or forearm
* 18 years and older
* Ability to consent
* American Society of Anesthesiologists class 1 to 3

Exclusion Criteria:

* Infection at the site of infection
* Abnormal anatomy at the site of infection
* Coagulopathy
* Severe Pulmonary Disease
* Preexisting neurological symptom(s) in the operated arm
* Pregnant patients
* Patients weighing less than 50 kg
* Allergy to amide type local anesthetics

Primary outcomes:
measure: Success Rate of the Block
timeFrame: Assessed 30 minutes after block completion
Secondary outcomes:
measure: Surgical success rate
timeFrame: Defined at the beginning of surgery until the end of surgery
measure: Technique duration
timeFrame: Time required in seconds for the retroclavicular block technique completion, assessed during block performance
measure: Needle visualization
timeFrame: Assessed after study completion, once all 50 patients will have been completed. Assessment will take place in the weeks following study completion
measure: Patient discomfort
timeFrame: Assessed immediately after the block
measure: Patient satisfaction
timeFrame: Assessed 48 hours after the block
measure: Sensitive Block Progression
timeFrame: Assessed 10, 20, 30 minutes after the block
measure: Motor Block Progression
timeFrame: Assessed 10, 20, 30 minutes after the block
measure: Complication Rate
timeFrame: Assessed 48 hours after the block
measure: Duration of the Block's Effects
timeFrame: Assessed 48 hours after the block
measure: Use of narcotic for tourniquet pain
timeFrame: Assessed throughout the surgery
measure: Rate of Neurostimulation Usage
timeFrame: Assessed during the block
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Pablo Echave, Doctor
role: PRINCIPAL_INVESTIGATOR
References: