The Retroclavicular Approach for Regional Anesthesia

Ultrasound-Guided Brachial Plexus Regional Anesthesia by the Novel Retroclavicular Approach : A Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Describe Novel Approach to Brachial Plexus Anesthesia
• Intervention / Treatment: Procedure: Retroclavicular block

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regional anesthesia; Recruit 50 patient having elbow, forearm, wrist or hand surgery and block brachial plexus using the novel retroclavicular approach	Procedure: Retroclavicular block; Retroclavicular approach ultrasound guided regional anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success Rate of the Block	Success is defined as complete sensory loss in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand.	Assessed 30 minutes after block completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor Block Progression	Progress of the motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand at 10, 20, and 30 minutes after block completion (mepivacaine injection). The scale used is: 0: no motor block, 1: paresis, 2: paralysis. No units are attached to this scale	Assessed 10, 20, 30 minutes after the block
Patient satisfaction	Using a VAS, patients will quantify their satisfaction with the retroclavicular technique throughout the study period.	Assessed 48 hours after the block
Duration of the Block's Effects	Duration of the block will be evaluated using 3 criteria: patient's subjective opinion of when the block receded (time of the day), time at which first oral analgesia is taken, and time of first onset of pain. Units involved is time (for example "3 pm".)	Assessed 48 hours after the block
Rate of Neurostimulation Usage	At the discretion of the anesthesiologist performing the block, neurostimulation can be used to supplement ultrasound guidance. This will be recorded as a YES or NO (neurostimulation used or not). No units attached to this rate.	Assessed during the block
Surgical success rate	Success rate is defined as avoidance of rescue analgesic technique. These techniques are defined as: adding local anesthetic locally by surgeon, rescue intravenous narcotics in excess of 1 microgram per kilogram of patient weight, need for general anesthesia, rescue distal neural blockage by anesthesiologist. Data presented will be the need or not of a rescue analgesic technique	Defined at the beginning of surgery until the end of surgery
Technique duration	Number of seconds needed to complete the block, from time of local skin anesthesia until regional block needle removal (local skin anesthesia plus injection of mepivacaine)	Time required in seconds for the retroclavicular block technique completion, assessed during block performance
Needle visualization	Using the Likert standardized scale, two evaluators will individually quantify the ease of needle visualization using the video footage recorded by the ultrasound machine from all the retroclavicular blocks. Likert scale for visualization, is defined as: 1:very bad, 2: bad, 3: adequate, 4:good, 5: very good. No units are attached to this scale	Assessed after study completion, once all 50 patients will have been completed. Assessment will take place in the weeks following study completion
Patient discomfort	Using a Visual Analog Scale (VAS), patients will quantify the discomfort they experienced during the block. This assessment will take place in the minutes following mepivacaine injection and block needle withdrawal. The VAS scale is rated from 1-10, 1 being almost no pain and 10 being the worst pain ever. Assessment will be done by an independent person, not taking part in the study. The VAS has no units attached to it.	Assessed immediately after the block
Sensitive Block Progression	Progress of the sensory block in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand at 10, 20 and 30 minutes after block completion (mepivacaine injection). The scale used is: 0:no sensitive block, 1:analgesia, 2:anesthesia. No units are attached to this scale.	Assessed 10, 20, 30 minutes after the block
Complication Rate	With a phone call to the patient at 48 hours after injection of mepivacaine, complications will be searched for (pain at puncture site, paresthesia or paresis in the operated arm, signs of infection at puncture site such as redness or purulent discharge). Response is classified as YES or NO. No units attached to this scale. If patient reports paresthesia or paresis, further questioning over the phone will determine which nerve or cord is involved.	Assessed 48 hours after the block
Use of narcotic for tourniquet pain	If at any point during the surgery, patient complains of tourniquet pain, this will be noted as well as the analgesia given. Units is time of pain ("3 pm") and analgesia given ("micrograms of fentanyl").	Assessed throughout the surgery

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Investigators: Principal Investigator: Pablo Echave, Doctor, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: May 8, 2013
• First Posted (Estimate): May 13, 2013

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 9, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Infraclavicular block; Brachial Plexus; Retroclavicular Approach; Complications of retroclavicular approach; Success of retroclavicular approach
• Other Study ID Numbers: 13-020 (Fox Chase Cancer Cener)