The Retroclavicular Approach for Regional Anesthesia
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|ClinicalTrials.gov Identifier: NCT01852396|
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : August 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Describe Novel Approach to Brachial Plexus Anesthesia||Procedure: Retroclavicular block||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Ultrasound-Guided Brachial Plexus Regional Anesthesia by the Novel Retroclavicular Approach : A Feasibility Study|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
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
- Success Rate of the Block [ Time Frame: Assessed 30 minutes after block completion ]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.
- Surgical success rate [ Time Frame: Defined at the beginning of surgery until the end of surgery ]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 ]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 ]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 ]
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 ]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 ]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 ]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 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852396
|Centre Hospitalier Universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Pablo Echave, Doctor||Université de Sherbrooke|