The Retroclavicular Approach for Regional Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pablo Echave, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01852396
First received: April 22, 2013
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Describe Novel Approach to Brachial Plexus Anesthesia
Procedure: Retroclavicular block
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Ultrasound-Guided Brachial Plexus Regional Anesthesia by the Novel Retroclavicular Approach : A Feasibility Study

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Success Rate of the Block [ Time Frame: Assessed 30 minutes after block completion ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Surgical success rate [ Time Frame: Defined at the beginning of surgery until the end of surgery ] [ Designated as safety issue: No ]
    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

  • Technique duration [ Time Frame: Time required in seconds for the retroclavicular block technique completion, assessed during block performance ] [ Designated as safety issue: No ]
    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)

  • Needle visualization [ Time Frame: Assessed after study completion, once all 50 patients will have been completed. Assessment will take place in the weeks following study completion ] [ Designated as safety issue: No ]
    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

  • Patient discomfort [ Time Frame: Assessed immediately after the block ] [ Designated as safety issue: No ]

    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.


  • Patient satisfaction [ Time Frame: Assessed 48 hours after the block ] [ Designated as safety issue: No ]
    Using a VAS, patients will quantify their satisfaction with the retroclavicular technique throughout the study period.

  • Sensitive Block Progression [ Time Frame: Assessed 10, 20, 30 minutes after the block ] [ Designated as safety issue: No ]
    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.

  • Motor Block Progression [ Time Frame: Assessed 10, 20, 30 minutes after the block ] [ Designated as safety issue: No ]
    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

  • Complication Rate [ Time Frame: Assessed 48 hours after the block ] [ Designated as safety issue: Yes ]
    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.

  • Duration of the Block's Effects [ Time Frame: Assessed 48 hours after the block ] [ Designated as safety issue: No ]
    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".)

  • Use of narcotic for tourniquet pain [ Time Frame: Assessed throughout the surgery ] [ Designated as safety issue: No ]
    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").

  • Rate of Neurostimulation Usage [ Time Frame: Assessed during the block ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: April 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852396

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Pablo Echave, Doctor Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Pablo Echave, Anesthesiologist, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01852396     History of Changes
Other Study ID Numbers: 13-020
Study First Received: April 22, 2013
Last Updated: August 9, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Université de Sherbrooke:
Infraclavicular block
Brachial Plexus
Retroclavicular Approach
Complications of retroclavicular approach
Success of retroclavicular approach

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014