Clinical trial NCT04356521: Lateral Sagittal vs Costoclavicular Approach for Ultrasound-Guided Infraclavicular Block
Official title: Lateral Sagittal Versus Costoclavicular Approach for Ultrasound-Guided Infraclavicular Brachial Plexus Block: Comparison of Block Dynamics and Patient Comfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Nerve Block
Brachial Plexus Block
Keywords: Anesthesia, Conduction
Ultrasound
Brachial Plexus Block/methods
Infraclavicular
Costoclavicular approach
Lateral Sagittal approach
Upper Extremity
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2020-04-22
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An ultrasound-guided infraclavicular block performed with the costoclavicular (CC) approach and the lateral sagittal (LS) approach will be compared in patients scheduled for forearm and hand surgery.

Detailed description: The CC approach is a recently introduced infraclavicular approach that targets three cords (medial, lateral and posterior) located lateral to the axillary artery in the costoclavicular space. Cords in this space are located more superficially than with the classical approach at the lateral infraclavicular fossa and are clustered but maintain a consistent anatomical relationship with each other.

Patients will be divided into two groups:

Group LS: Ultrasound-guided infraclavicular block - lateral sagittal approach (20 ml 0.5% bupivacaine)

Group CC: Ultrasound-guided infraclavicular block - costoclavicular approach (20 ml 0.5% bupivacaine)

Eligibility criteria: Inclusion Criteria:

* Age 18 years to 65 years
* Patients scheduled for elective forearm and hand surgeries
* Patients with American Society of Anesthesiologists (ASA) 1-3

Exclusion Criteria:

* Patients not consenting/unwilling to participate
* Age \<18 years or \>65 years
* Patients with ASA 4
* Obesity (BMI \>30 kg/m2)
* Regional anesthesia contraindicated (thrombocytopenia, infection at injection site)
* Severe renal, cardiac, or hepatic disease
* History of hypersensitivity or allergy to local anesthetics
* History of opioid or steroid use for more than 4 weeks
* History of psychiatric disorders
* Analgesic treatment in the last 48 hours preoperatively
* Operations lasting less than 60 minutes and more than 180 minutes
* Patients who converted to general anesthesia

Primary outcomes:
measure: Performance time of the operator
timeFrame: During the block procedure
measure: Duration of start of motor block
timeFrame: 45 minutes after the block procedure
measure: Start time of the nervous block
timeFrame: 45 minutes after the block procedure
Secondary outcomes:
measure: Time of sensory block
timeFrame: Postoperative Day 1
measure: Time of motor block
timeFrame: Postoperative Day 1
measure: Patient Satisfaction
timeFrame: Postoperative Day 1
measure: Surgeon Satisfaction
timeFrame: Postoperative Day 1
measure: Number of needle redirections
timeFrame: During the block procedure
measure: Number of needle attempts
timeFrame: During the block procedure
measure: Number of patients who required a rescue block
timeFrame: 45 minutes after the block procedure
measure: Time of first analgesic request
timeFrame: Postoperative Day 1
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: BURHAN DOST
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leurcharusmee P, Elgueta MF, Tiyaprasertkul W, Sotthisopha T, Samerchua A, Gordon A, Aliste J, Finlayson RJ, Tran DQH. A randomized comparison between costoclavicular and paracoracoid ultrasound-guided infraclavicular block for upper limb surgery. Can J Anaesth. 2017 Jun;64(6):617-625. doi: 10.1007/s12630-017-0842-z. Epub 2017 Feb 15.
citation: Songthamwat B, Karmakar MK, Li JW, Samy W, Mok LYH. Ultrasound-Guided Infraclavicular Brachial Plexus Block: Prospective Randomized Comparison of the Lateral Sagittal and Costoclavicular Approach. Reg Anesth Pain Med. 2018 Nov;43(8):825-831. doi: 10.1097/AAP.0000000000000822.
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.
citation: Oh C, Noh C, Eom H, Lee S, Park S, Lee S, Shin YS, Ko Y, Chung W, Hong B. Costoclavicular brachial plexus block reduces hemidiaphragmatic paralysis more than supraclavicular brachial plexus block: retrospective, propensity score matched cohort study. Korean J Pain. 2020 Apr 1;33(2):144-152. doi: 10.3344/kjp.2020.33.2.144.
citation: Layera S, Aliste J, Bravo D, Fernandez D, Garcia A, Finlayson RJ, Tran DQ. Single- versus double-injection costoclavicular block: a randomized comparison. Reg Anesth Pain Med. 2020 Mar;45(3):209-213. doi: 10.1136/rapm-2019-101167. Epub 2020 Jan 14.
citation: Mistry T, Balavenkatasubhramanian J, Natarajan V, Kuppusamy E. Ultrasound-guided bilateral costoclavicular brachial plexus blocks for single-stage bilateral upper limb surgeries: Abstain or indulge. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):556-557. doi: 10.4103/joacp.JOACP_222_18. No abstract available.
citation: Monzo E, Hadzic A. Costoclavicular approach to the brachial plexus block: simple or double injection? Reg Anesth Pain Med. 2019 Sep 29:rapm-2019-100852. doi: 10.1136/rapm-2019-100852. Online ahead of print. No abstract available.
citation: Silva GR, Borges DG, Lopes IF, Ruzi RA, Costa PRRM, Mandim BLDS. [Ultrasound-guided costoclavicular block as an alternative for upper limb anesthesia in obese patients]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):510-513. doi: 10.1016/j.bjan.2019.01.004. Epub 2019 Sep 10.