- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04102358
The Need for Supplemental Blocks in Infraclavicular Brachial Plexus Blocks
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 Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Derince
-
Kocaeli, Derince, Turkey, 41900
- Derince Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Single injection
Patients who received an infraclavicular block with a single injection technique were included in Group-S.
|
infraclavicular blocks performed with single injection
|
|
Triple injection
Patients who received an infraclavicular block with a triple injection technique were included in Group-T.
|
infraclavicular blocks performed with triple injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Supplemented blocks
Time Frame: 1 hour
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complete Failure
Time Frame: 30 minutes
|
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
|
|
Recovery of sensory block
Time Frame: 24 hours
|
the first time of the need for analgesics
|
24 hours
|
|
Discomfort during IC block
Time Frame: 1 hour
|
paresthesia during the infraclavicular block
|
1 hour
|
|
Inadvertent vascular puncture
Time Frame: 1 hour
|
inadvertent vascular puncture during the infraclavicular block
|
1 hour
|
Collaborators and Investigators
Investigators
- Study Chair: Tuncay Colak, Prof, Kocaeli University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- U1111-1240-8832
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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