Clinical trial NCT02673086: Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block
Official title: Could the Retroclavicular Block Alternative for Ultrasound-guided Infraclavicular Block: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Upper Extremity
Keywords: retroclavicular approach
coracoid approach
ultrasound
upper limb surgery
needle visibility
infraclavicular brachial plexus block
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Needle visibility
timeFrame: 10 minutes after the needle inserted the skin
Secondary outcomes:
measure: Technique duration
timeFrame: Time required in seconds for the block completion (10 minutes)
measure: Patient satisfaction using a visual analogue scale
timeFrame: Assessed 48 hours after the block
measure: Surgical success rate
timeFrame: 6 hours after the block
measure: supplemental analgesic use
timeFrame: 90 minutes after block completion
measure: complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection
timeFrame: 24 hours
measure: motor block success rate
timeFrame: Assessed 40 minutes after block completion
measure: Success Rate of the sensorial Block
timeFrame: Assessed 30 minutes after block completion
measure: Block performance related pain
timeFrame: 10 minutes after the needle inserted the skin
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Study officials:
affiliation: Antalya Training and Research Hospital
name: Nılgun Kavrut Ozturk, MD
role: STUDY_DIRECTOR
References:
citation: 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.