Disorder of Upper ExtremityNCT02673086
Retroclavicular Versus Coracoid Approach for Infraclavicular Brachial Plexus Block
A study testing coracoid approach and retroclavicular approach in people with Disorder of Upper Extremity, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to compare needle tip visibility between the coracoid approach and retroclavicular approach for infraclavicular brachial plexus block in patients undergoing elective upper limb surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Disorder of Upper Extremity
- What is being tested?
- coracoid approach and retroclavicular approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2015to Jun 2016
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
- American Society of Anesthesiologists class 1 to 3
- Ability to consent
Who cannot join
- History of allergic reaction to local anaesthetics
- Peripheral neuropathy
- Renal or hepatic insufficiency
- Coagulation disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, 07100
About this study
Official title: Could the Retroclavicular Block Alternative for Ultrasound-guided Infraclavicular Block: A Prospective Randomized Controlled Trial
The primary aim of this study is to compare needle tip visibility between the coracoid approach and retroclavicular approach for infraclavicular brachial plexus block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the differences between the two groups in the needle shaft visibility, sensorial block success rate, block performance time, block performance related pain, motor block success rate, surgical success rate, complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.
Read the detailed description
Infraclavicular blocks are performed with different approaches. Infraclavicular block is usually traditionally performed at coracoid approach. Different approaches has been described for this block such as vertical approach. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with traditionally coracoid approach for infraclavicular brachial plexus block. 100 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Coracoid approach for infraclavicular block (Group I), retroclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 10 minutes until 30min after local anesthetic injection.Success rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects, the needle tip and shaft visibility, procedure time,duration of the block's effect, use of supplemental local anesthetic, use of analgesic.are compared with both groups.
- Conditions
- Disorder of Upper Extremity
- Being tested
- coracoid approach, retroclavicular approach
- Keywords
- retroclavicular approach, coracoid approach, ultrasound, upper limb surgery, needle visibility, infraclavicular brachial plexus block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coracoid approachOther
Coracoid approach for ultrasound guided infraclavicular brachial plexus block
retroclavicular approachOther
retroclavicular approach for ultrasound guided infraclavicular brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| coracoid approach | Active comparator | Patients in this group will be randomized to receive an coracoid approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block . Receives: Other: coracoid approach |
| retroclavicular approach | Active comparator | Patients in this group will be randomized to receive an retroclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block . Receives: Other: retroclavicular approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle visibility
To assess the needle visibility will be reviewed by two anesthesiologists using a 5-point Likert scale.
Measured: 10 minutes after the needle inserted the skin
Secondary outcomes (8)
Technique duration
Number of seconds needed to complete the block, from time the first insertion of the blocking needle to its removal.
Measured: Time required in seconds for the block completion (10 minutes)
Patient satisfaction using a visual analogue scale
Using a visual analogue scale , patients will quantify their satisfaction with the retroclavicular coracoid technique.
Measured: Assessed 48 hours after the block
Surgical success rate
Surgical success is defined as no requirement for additional local anesthetic and the use of intravenous analgesic, rescue blocks, or general anesthesia during the surgery.
Measured: 6 hours after the block
supplemental analgesic use
the need for additional intravenous analgesic
Measured: 90 minutes after block completion
complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection
Patients are asked about possible complications and all the patients studied is evaluated by performing bedside ultrasound examinations of the chest before discharge.
Measured: 24 hours
motor block success rate
Motor function is evaluate for flexion of the elbow, opposition of the thumb, and adduction of the thumb based on a three point scale (0 = normal strength, 1 = paresis, 2 = paralysis)
Measured: Assessed 40 minutes after block completion
Success Rate of the sensorial Block
Sensory assessments are performed every 5 minutes after needle removal for 30 minute in the regions of the radial, median, ulnar, musculocutaneous of the forearm based on a three point scale with cold test ( 0: normal sensation, 1:analgesia, 2: anesthesia).
Measured: Assessed 30 minutes after block completion
Block performance related pain
Block performance related pain is evaluated with a verbal rating scale score after the removel of the needle.
Measured: 10 minutes after the needle inserted the skin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of Upper ExtremityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nılgun Kavrut Ozturk, MD, Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673086
- Sponsor's protocol ID
- AntalyaTRH 010
- Status last verified
- Aug 2016
- First submitted
- 19 Jan 2016
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28421316
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could the Retroclavicular Block Alternative for Ultrasound-guided Infraclavicular Block: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02673086
- Acronym / sponsor ID
- AntalyaTRH 010
- Conditions
- Disorder of Upper Extremity
- Keywords
- retroclavicular approach, coracoid approach, ultrasound, upper limb surgery, needle visibility, infraclavicular brachial plexus block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Dec 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Feb 2016 (estimated)
- 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.
The primary aim of this study is to compare needle tip visibility between the coracoid approach and retroclavicular approach for infraclavicular brachial plexus block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the differences between the two groups in the needle shaft visibility, sensorial block success rate, block performance time, block performance related pain, motor block success rate, surgical success rate, complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.
Detailed description
Infraclavicular blocks are performed with different approaches. Infraclavicular block is usually traditionally performed at coracoid approach. Different approaches has been described for this block such as vertical approach. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with traditionally coracoid approach for infraclavicular brachial plexus block. 100 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Coracoid approach for infraclavicular block (Group I), retroclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 10 minutes until 30min after local anesthetic injection.Success rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and incidence rate of adverse effects, the needle tip and shaft visibility, procedure time,duration of the block's effect, use of supplemental local anesthetic, use of analgesic.are compared with both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| coracoid approach | Active comparator | Other: coracoid approachPatients in this group will be randomized to receive an coracoid approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block . |
| retroclavicular approach | Active comparator | Other: retroclavicular approachPatients in this group will be randomized to receive an retroclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients who undergo elective forearm or hand surgery under infraclavicular brachial plexus block
- American Society of Anesthesiologists class 1 to 3
- Ability to consent
Key exclusion criteria (4 listed)
- History of allergic reaction to local anaesthetics
- Peripheral neuropathy
- Renal or hepatic insufficiency
- Coagulation disorders
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 |
|---|---|---|
| coracoid approachCoracoid approach for ultrasound guided infraclavicular brachial plexus block | Other | coracoid approach |
| retroclavicular approachretroclavicular approach for ultrasound guided infraclavicular brachial plexus block | Other | retroclavicular approach |
Primary outcome
Needle visibility
Time frame: 10 minutes after the needle inserted the skin
To assess the needle visibility will be reviewed by two anesthesiologists using a 5-point Likert scale.
8 secondary outcomes
Technique duration
Time frame: Time required in seconds for the block completion (10 minutes)
Patient satisfaction using a visual analogue scale
Time frame: Assessed 48 hours after the block
Surgical success rate
Time frame: 6 hours after the block
supplemental analgesic use
Time frame: 90 minutes after block completion
complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection
Time frame: 24 hours
motor block success rate
Time frame: Assessed 40 minutes after block completion
Success Rate of the sensorial Block
Time frame: Assessed 30 minutes after block completion
Block performance related pain
Time frame: 10 minutes after the needle inserted the skin
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 19 Jun 2017.
- Derived from this study: PubMed 28421316Kavrut 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.
- Individual participant dataSharing planned: No
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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.
Nılgun Kavrut Ozturk, MD study director
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coracoid approach and retroclavicular approach in people with Disorder of Upper Extremity, run by Antalya 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 4 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 19 Jun 2017. 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?
Needle visibility (time frame: 10 minutes after the needle inserted the skin). 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 NCT02673086, which also lists 1 linked publication.
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 19 Jun 2017.