Clinical trial NCT04102358: The Need for Supplemental Blocks in Infraclavicular Brachial Plexus Blocks
Official title: The Need for Supplemental Blocks in Single Versus Triple Injections in Infraclavicular Brachial Plexus Blocks With Medial Approach: A Clinical and an Anatomical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Regional
Keywords: Vertical infraclavicular block
brachial plexus anatomy
Lead sponsor: Derince Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 139
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent surgery for upper extremity under medial approach infraclavicular block between October 2017 and March 2019

Brief summary: Theoretically, all surgeries below mid-humerus can be done under infraclavicular (IC) blocks. Following the introduction of ultrasonography (USG) to clinical anesthesia, plexus, and nerve blocks under the guidance of USG have gained wide acceptance for the high rates of block success and low risk of complications (1). In this study, the main aim is to evaluate the single injection and triple injection techniques in IC blocks with a USG-guided medial approach in terms of block success and the need for supplementary blocks. The secondary goals are to compare the complication rates and sensory block durations and to discuss the possible reasons for the failure of the blocks.

Detailed description: Theoretically all surgeries below mid-humerus can be done under infraclavicular (IC) blocks. Following the introduction of ultrasonography (USG) to the clinical anesthesia, plexus and nerve blocks under the guidance of USG have gained wide acceptance for the high rates of block success, and low risk of complications. At the same time, it was also shown that USG-guided IC blocks can shorten procedural times and accelerate the onset of the blocks.

Several methods for IC blocks have been described. Based on the anatomical knowledge, we hypothesized that in medial approaches the need for supplementary blocks would be low with single injections as well as triple injections. In this study, the main aim is to evaluate the single injection and triple injection techniques in IC blocks with a USG-guided medial approach in terms of block success and the need for supplementary blocks. The secondary goals are to compare the complication rates and sensory block durations and to discuss the possible reasons for the failure of the blocks.

Medical records of 139 patients scheduled for elective or emergent hand, wrist, forearm, elbow, and distal arm surgery were analyzed. Patients older than 14 years with ASA physical status I-III who underwent surgery between October 2017 and March 2019 were retrospectively evaluated. Exclusion criteria included non-cooperative patients, refusal of the regional anesthesia, known neuropathy that could prevent the evaluation of the efficacy of the block, different techniques used for infraclavicular brachial plexus blocks (lateral sagittal, coracoid, ...etc.), and known allergy to local anesthetic drugs.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-III
* upper extremity surgery
* blocks were performed by the same anesthesiologist

Exclusion Criteria:

* non-cooperative patients
* refusal of the regional anesthesia
* known neuropathy
* different technique used for infraclavicular brachial plexus blocks (lateral sagittal, coracoid, ...etc.)
* known allergy to local anesthetic drugs.

Primary outcomes:
measure: Supplemented blocks
timeFrame: 1 hour
Secondary outcomes:
measure: Complete Failure
timeFrame: 30 minutes
measure: Recovery of sensory block
timeFrame: 24 hours
measure: Discomfort during IC block
timeFrame: 1 hour
measure: Inadvertent vascular puncture
timeFrame: 1 hour
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Derince Training and Research Hospital
state: Derince
Study officials:
affiliation: Kocaeli University
name: Tuncay Colak, Prof
role: STUDY_CHAIR
References:
citation: Abrahams MS, Aziz MF, Fu RF, Horn JL. Ultrasound guidance compared with electrical neurostimulation for peripheral nerve block: a systematic review and meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Mar;102(3):408-17. doi: 10.1093/bja/aen384. Epub 2009 Jan 26.
citation: Li JW, Songthamwat B, Samy W, Sala-Blanch X, Karmakar MK. Ultrasound-Guided Costoclavicular Brachial Plexus Block: Sonoanatomy, Technique, and Block Dynamics. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):233-240. doi: 10.1097/AAP.0000000000000566.
citation: Kilka HG, Geiger P, Mehrkens HH. [Infraclavicular vertical brachial plexus blockade. A new method for anesthesia of the upper extremity. An anatomical and clinical study]. Anaesthesist. 1995 May;44(5):339-44. doi: 10.1007/s001010050162. German.