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

Retroclavicular Approach vs Infraclavicular Approach for Brachial Plexus Block in Obese

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.

Study Overview

• Status: Unknown
• Conditions: Forearm Injuries; Hand Injuries
• Intervention / Treatment: Drug: Bupivacaine; Device: Ultrasound; Other: Ultrasound guided retroclavicular block; Other: Ultrasound guided coracoid infraclavicular 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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• <18 years
• Local infection
• Coagulopaty

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guided retroclavicular block; Ultrasound guided retroclavicular block group patients (Group R) will receive 30 cc %0.5 Bupivacaine	Drug: Bupivacaine; Device: Ultrasound; Other: Ultrasound guided retroclavicular block; Ultrasound guided retroclavicular block for forearm or hand surgery; Other Names: Group R; Other: Ultrasound guided coracoid infraclavicular block; Ultrasound guided infraclavicular block for forearm or hand surgery; Other Names: Group C
Active Comparator: Ultrasound guided infraclavicular block; Ultrasound guided coracoid infraclavicular block group patients (Group C) will receive 30 cc %0.5 Bupivacaine	Drug: Bupivacaine; Device: Ultrasound; Other: Ultrasound guided retroclavicular block; Ultrasound guided retroclavicular block for forearm or hand surgery; Other Names: Group R; Other: Ultrasound guided coracoid infraclavicular block; Ultrasound guided infraclavicular block for forearm or hand surgery; Other Names: Group C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Anticipated): May 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: December 9, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Estimate): December 13, 2016
• Last Update Submitted That Met QC Criteria: December 12, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Ultrasound; Infraclavicular block; Retroclavicular block
• Additional Relevant MeSH Terms: Arm Injuries; Wounds and Injuries; Hand Injuries; Forearm Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 31 (Other Identifier: IASO Thessalias)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO