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

Hand Injuries Clinical Trial

Official title:

Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02990702
• Other study ID #: 31
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 9, 2016
• Last updated: December 12, 2016
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: December 2016
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18-80 years

• BMI>30

• Forearm- Hand surgery

Exclusion Criteria:

• <18 years

• Local infection

• Coagulopaty

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Forearm Injuries
• Hand Injuries
• Wounds and Injuries

Intervention

Other:
• Ultrasound guided retroclavicular block
Ultrasound guided retroclavicular block for forearm or hand surgery
• Ultrasound guided coracoid infraclavicular block
Ultrasound guided infraclavicular block for forearm or hand surgery

Drug:
• Bupivacaine

Device:
• Ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technique duration	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.	Measured directly during the procedure with a chronometer.	No
Primary	Surgery completion under regional block	Success rate is defined as the completion of the intended surgery under regional anaesthesia with retroclavicular block without the need for a rescue technique.	Success is defined at end of surgery for which block was done, generally within 1 to 3 hours after block is performed	No
Secondary	Sensorial 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. 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).	Assessed 10, 20 and 30 minutes after block completion	No
Secondary	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. 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 completion	No
Secondary	Needle visualization	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)	Assessed one week after study completion	No