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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04102358
Other study ID # U1111-1240-8832
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date May 30, 2019

Study information

Verified date February 2024
Source Derince Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 139
Est. completion date May 30, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Medial approach infraclavicular block with single injection
infraclavicular blocks performed with single injection
Medial approach infraclavicular block with triple injection
infraclavicular blocks performed with triple injection

Locations

Country Name City State
Turkey Derince Training and Research Hospital Kocaeli Derince

Sponsors (1)

Lead Sponsor Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Supplemented blocks 30 minutes after the block, if one or two of the median, radial, ulnar or musculocutaneous nerves were still unblocked, these nerves were located either with a peripheric nerve stimulator or an ultrasound, in the axilla or on the more distal parts of their traces on arm and forearm and then supplemented. 1 hour
Secondary Complete Failure If more than two of these nerves (median, radial, ulnar or musculocutaneous) were remained unblocked, no supplementary blocks were applied, then it was considered as having a failed block and general anesthesia was administered. 30 minutes
Secondary Recovery of sensory block the first time of the need for analgesics 24 hours
Secondary Discomfort during IC block paresthesia during the infraclavicular block 1 hour
Secondary Inadvertent vascular puncture inadvertent vascular puncture during the infraclavicular block 1 hour
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