Anesthesia, RegionalNCT04102358
The Need for Supplemental Blocks in Infraclavicular Brachial Plexus Blocks
An observational study of Anesthesia, Regional, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Anesthesia, Regional
- What is being tested?
- Medial approach infraclavicular block with single injection and Medial approach infraclavicular block with triple injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 139 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2017to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients underwent surgery for upper extremity under medial approach infraclavicular block between October 2017 and March 2019
Who may be able to join
- ASA physical status I-III
- upper extremity surgery
- blocks were performed by the same anesthesiologist
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Training and Research Hospital
Kocaeli, Derince, 41900
About this study
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
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.
Read the 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.
- Conditions
- Anesthesia, Regional
- Being tested
- Medial approach infraclavicular block with single injection, Medial approach infraclavicular block with triple injection
- Keywords
- Vertical infraclavicular block, brachial plexus anatomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial approach infraclavicular block with single injectionProcedure or surgery
infraclavicular blocks performed with single injection
Medial approach infraclavicular block with triple injectionProcedure or surgery
infraclavicular blocks performed with triple injection
| Study group | Role | What they receive |
|---|---|---|
| Single injection | Patients who received an infraclavicular block with a single injection technique were included in Group-S. Receives: Procedure: Medial approach infraclavicular block with single injection | |
| Triple injection | Patients who received an infraclavicular block with a triple injection technique were included in Group-T. Receives: Procedure: Medial approach infraclavicular block with triple injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (4)
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.
Measured: 30 minutes
Recovery of sensory block
the first time of the need for analgesics
Measured: 24 hours
Discomfort during IC block
paresthesia during the infraclavicular block
Measured: 1 hour
Inadvertent vascular puncture
inadvertent vascular puncture during the infraclavicular block
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start1 Oct 2017
- Primary completion31 Mar 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, RegionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hande Gurbuz, Derince Training and Research Hospital
- Investigators
- Tuncay Colak, Prof, Study chair, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102358
- Sponsor's protocol ID
- U1111-1240-8832
- Status last verified
- Feb 2024
- First submitted
- 23 Sep 2019
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
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.
PubMed 19174373Li 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.
PubMed 28157792Kilka 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.
PubMed 7611581
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04102358
- Acronym / sponsor ID
- U1111-1240-8832
- Conditions
- Anesthesia, Regional
- Keywords
- Vertical infraclavicular block, brachial plexus anatomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single injection | – | Procedure: Medial approach infraclavicular block with single injectionPatients who received an infraclavicular block with a single injection technique were included in Group-S. |
| Triple injection | – | Procedure: Medial approach infraclavicular block with triple injectionPatients who received an infraclavicular block with a triple injection technique were included in Group-T. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients underwent surgery for upper extremity under medial approach infraclavicular block between October 2017 and March 2019
Key inclusion criteria (3 listed)
- ASA physical status I-III
- upper extremity surgery
- blocks were performed by the same anesthesiologist
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medial approach infraclavicular block with single injectioninfraclavicular blocks performed with single injection | Procedure or surgery | Single injection |
| Medial approach infraclavicular block with triple injectioninfraclavicular blocks performed with triple injection | Procedure or surgery | Triple injection |
Primary outcome
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.
4 secondary outcomes
Complete Failure
Time frame: 30 minutes
Recovery of sensory block
Time frame: 24 hours
Discomfort during IC block
Time frame: 1 hour
Inadvertent vascular puncture
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 19174373Abrahams 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.
- Background: PubMed 28157792Li 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.
- Background: PubMed 7611581Kilka 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuncay Colak, Prof study chair
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, Regional, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supplemented blocks (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04102358, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.