Clinical trial NCT03190551: Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block
Official title: A Randomized Controlled Trial Comparing Retroclavicular and Costoclavicular Approach for Infraclavicular Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Upper Extremity
Keywords: infraclavicular brachial plexus block
retroclavicular approach
costoclavicular approach
upper limb surgery
needle shaft visibility
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-06-19
Enrollment: 60
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 shaft visibility between the retroclavicular approach and costoclavicular 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 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. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with costoclavicular approach for infraclavicular brachial plexus block. 60 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Retroclavicular approach for infraclavicular block (Group I), costoclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30 min 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 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 shaft 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 24 hours after the block
measure: supplemental analgesic used
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: Hayri Fatih Metinyurt, MD
role: STUDY_DIRECTOR
affiliation: Antalya Training and Research Hospital
name: Nilgun Kavrut Ozturk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Training and Research Hospital
name: Ali Sait Kavakli, MD
role: PRINCIPAL_INVESTIGATOR
References: