Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block

Could the Retroclavicular Block Alternative for Ultrasound-guided Infraclavicular Block: A Prospective Randomized Controlled Trial

The primary aim of this study is to compare needle tip visibility between the coracoid approach and retroclavicular approach for infraclavicular brachial plexus block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the differences between the two groups in the needle shaft visibility, sensorial block success rate, block performance time, block performance related pain, motor block success rate, surgical success rate, complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.

Study Overview

• Status: Completed
• Conditions: Disorder of Upper Extremity
• Intervention / Treatment: Other: coracoid approach; Other: retroclavicular approach

Detailed Description

Infraclavicular blocks are performed with different approaches. Infraclavicular block is usually traditionally performed at coracoid approach. Different approaches has been described for this block such as vertical approach. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with traditionally coracoid approach for infraclavicular brachial plexus block. 100 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Coracoid approach for infraclavicular block (Group I), retroclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 10 minutes until 30min after local anesthetic injection.Success rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects, the needle tip and shaft visibility, procedure time,duration of the block's effect, use of supplemental local anesthetic, use of analgesic.are compared with both groups.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07100
    • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
• American Society of Anesthesiologists class 1 to 3
• Ability to consent

Exclusion Criteria:

• History of allergic reaction to local anaesthetics
• Peripheral neuropathy
• Renal or hepatic insufficiency
• Coagulation disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: retroclavicular approach; Patients in this group will be randomized to receive an retroclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .	Other: retroclavicular approach; retroclavicular approach for ultrasound guided infraclavicular brachial plexus block
Active Comparator: coracoid approach; Patients in this group will be randomized to receive an coracoid approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block .	Other: coracoid approach; Coracoid approach for ultrasound guided infraclavicular brachial plexus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Needle visibility	To assess the needle visibility will be reviewed by two anesthesiologists using a 5-point Likert scale.	10 minutes after the needle inserted the skin

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technique duration	Number of seconds needed to complete the block, from time the first insertion of the blocking needle to its removal.	Time required in seconds for the block completion (10 minutes)
Patient satisfaction using a visual analogue scale	Using a visual analogue scale , patients will quantify their satisfaction with the retroclavicular coracoid technique.	Assessed 48 hours after the block
Surgical success rate	Surgical success is defined as no requirement for additional local anesthetic and the use of intravenous analgesic, rescue blocks, or general anesthesia during the surgery.	6 hours after the block
supplemental analgesic use	the need for additional intravenous analgesic	90 minutes after block completion
complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection	Patients are asked about possible complications and all the patients studied is evaluated by performing bedside ultrasound examinations of the chest before discharge.	24 hours
motor block success rate	Motor function is evaluate for flexion of the elbow, opposition of the thumb, and adduction of the thumb based on a three point scale (0 = normal strength, 1 = paresis, 2 = paralysis)	Assessed 40 minutes after block completion
Success Rate of the sensorial Block	Sensory assessments are performed every 5 minutes after needle removal for 30 minute in the regions of the radial, median, ulnar, musculocutaneous of the forearm based on a three point scale with cold test ( 0: normal sensation, 1:analgesia, 2: anesthesia).	Assessed 30 minutes after block completion
Block performance related pain	Block performance related pain is evaluated with a verbal rating scale score after the removel of the needle.	10 minutes after the needle inserted the skin

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Study Director: Nılgun Kavrut Ozturk, MD, Antalya Training And Research Hospital

Publications and helpful links

General Publications

• Kavrut Ozturk N, Kavakli AS. Comparison of the coracoid and retroclavicular approaches for ultrasound-guided infraclavicular brachial plexus block. J Anesth. 2017 Aug;31(4):572-578. doi: 10.1007/s00540-017-2359-6. Epub 2017 Apr 18.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 19, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 3, 2016

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: June 15, 2017
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: ultrasound; infraclavicular brachial plexus block; retroclavicular approach; upper limb surgery; coracoid approach; needle visibility
• Other Study ID Numbers: AntalyaTRH 010

Plan for Individual participant data (IPD)

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