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Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese Patients

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ClinicalTrials.gov Identifier: NCT02990702
Recruitment Status : Unknown
Verified December 2016 by Bora Bilal, Kahramanmaras Sutcu Imam University.
Recruitment status was:  Not yet recruiting
First Posted : December 13, 2016
Last Update Posted : December 13, 2016
Sponsor:
Information provided by (Responsible Party):
Bora Bilal, Kahramanmaras Sutcu Imam University

Brief Summary:
The retroclavicular approach for brachial plexus anesthesia requires an optimal angle between the needle and the ultrasound beam. Retroclavicular approach has already been proven effective and safe in the past. The general objective is to provide a formal comparison between the retroclavicular approach and coracoid infraclavicular approach for brachial plexus anaesthesia. This study should represent the differences between the two techniques.

Condition or disease Intervention/treatment Phase
Forearm Injuries Hand Injuries Other: Ultrasound guided retroclavicular block Other: Ultrasound guided coracoid infraclavicular block Drug: Bupivacaine Device: Ultrasound Phase 4

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.

It is recognized that regional anesthesia is more difficult to perform in obese patients. Anatomic landmarks are harder to localize in this population and ultrasound guidance is more difficult because of the attenuation of the ultrasound beam by adipose tissue. The complication rate of regional techniques is also reported to be higher in the obese patient population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Official Title: Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese
Study Start Date : January 2017
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: Ultrasound guided retroclavicular block
Ultrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine
Other: Ultrasound guided retroclavicular block
Ultrasound guided retroclavicular block for forearm or hand surgery
Other Name: Group R

Other: Ultrasound guided coracoid infraclavicular block
Ultrasound guided infraclavicular block for forearm or hand surgery
Other Name: Group C

Drug: Bupivacaine
Device: Ultrasound
Active Comparator: Ultrasound guided infraclavicular block
Ultrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine
Other: Ultrasound guided retroclavicular block
Ultrasound guided retroclavicular block for forearm or hand surgery
Other Name: Group R

Other: Ultrasound guided coracoid infraclavicular block
Ultrasound guided infraclavicular block for forearm or hand surgery
Other Name: Group C

Drug: Bupivacaine
Device: Ultrasound



Primary Outcome Measures :
  1. Technique duration [ Time Frame: Measured directly during the procedure with a chronometer. ]
    The performance time corresponds to the sum of imaging time and needling time. It is expressed in minutes. Analysis of the primary outcome: performance time will be analyzed with a non-inferiority test of the averages, with the objective of finding that the experimental retroclavicular approach is no longer to perform than the coracoid infraclavicular approach.

  2. Surgery completion under regional block [ Time Frame: Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed ]
    Success rate is defined as the completion of the intended surgery under regional anaesthesia with retroclavicular block without the need for a rescue technique.


Secondary Outcome Measures :
  1. Sensorial block progression [ Time Frame: Assessed 10, 20 and 30 minutes after block completion ]
    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. The scale used is: 0:no sensitive block, 1:analgesia (loss of pain but not tactile sensation), 2:anesthesia (loss of pain and tactile sensation).

  2. Motor Block Progression [ Time Frame: Assessed 10, 20, 30 minutes after the block completion ]
    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. The scale used is: 0: no motor block, 1: paresis, 2: paralysis. No units are attached to this scale.

  3. Needle visualization [ Time Frame: Assessed one week after study completion ]
    Procedures will be recorded and reviewed simultaneously after study completion by 2 independent anesthesiologists skilled in US-guided regional anesthesia using a 5-point Likert scale to rate needle visibility (1=very poor,2=poor,3=fair,4=good,5=very good)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-80 years
  • BMI>30
  • Forearm- Hand surgery

Exclusion Criteria:

  • <18 years
  • Local infection
  • Coagulopaty
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Responsible Party: Bora Bilal, Assistant Proffesor, Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT02990702    
Other Study ID Numbers: 31
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Bora Bilal, Kahramanmaras Sutcu Imam University:
Infraclavicular block
Retroclavicular block
Ultrasound
Additional relevant MeSH terms:
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Wounds and Injuries
Hand Injuries
Forearm Injuries
Arm Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents