Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Disorder of Upper Extremity

Intervention / Treatment
-----------------
* Other: coracoid approach
* Other: retroclavicular approach


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retroclavicular approach, coracoid approach, ultrasound, upper limb surgery, needle visibility, infraclavicular brachial plexus block