Disorder of Upper ExtremityNCT03190551
Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block
A study testing retroclavicular approach and costoclavicular 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 shaft visibility between the retroclavicular approach and costoclavicular 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?
- retroclavicular approach and costoclavicular approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2017to Apr 2017
- 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: A Randomized Controlled Trial Comparing Retroclavicular and Costoclavicular Approach for Infraclavicular Brachial Plexus Block
The primary aim of this study is to compare needle shaft visibility between the retroclavicular approach and costoclavicular 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 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. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with costoclavicular approach for infraclavicular brachial plexus block. 60 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Retroclavicular approach for infraclavicular block (Group I), costoclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30 min 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 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
- retroclavicular approach, costoclavicular approach
- Keywords
- infraclavicular brachial plexus block, retroclavicular approach, costoclavicular approach, upper limb surgery, needle shaft visibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retroclavicular approachOther
Retroclavicular approach for ultrasound guided infraclavicular brachial plexus block
costoclavicular approachOther
costoclavicular approach for ultrasound guided infraclavicular brachial plexus block
| Study group | Role | What they receive |
|---|---|---|
| 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 |
| costoclavicular approach | Active comparator | Patients in this group will be randomized to receive an costoclavicular approach to Ultrasound Guided Infraclavicular Brachial Plexus Nerve Block . Receives: Other: costoclavicular approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needle shaft visibility
Needle visibility reviewed by two anesthesiologists using a 5-point Likert scale
Measured: 10 minutes after the needle inserted the skin
Secondary outcomes (7)
Technique duration
Number of seconds needed to complete the block, from time of local skin anesthesia until regional block needle removal.
Measured: Time required in seconds for the block completion (10 minutes)
Patient satisfaction using a visual analogue scale
Using a visual analog scala, patients will quantify their satisfaction with the retroclavicular and costaclavicular technique .
Measured: Assessed 24 hours after the block
supplemental analgesic used
The use of supplementary local anesthetic and the use of intravenous narcotics were recorded.
Measured: 90 minutes after block completion
complications such as pneumothorax, hemothorax, intraarterial injection, intravenous injection
Asked about possible complications
Measured: 24 hours
motor block success rate
Success is defined as complete motor block in the distribution of the radial, median, ulnar, musculocutaneous nerves of the forearm and hand
Measured: Assessed 40 minutes after block completion
Success Rate of the sensorial Block
Success is defined as complete sensory loss in the distribution of the radial, median, ulnar, musculocutaneous, and medial cutaneous nerves of the forearm and hand
Measured: Assessed 30 minutes after block completion
Block performance related pain
Block performance related pain was evaluated with a visual analog scala after the removal 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 posted19 Jun 2017
- Study startJan 2017
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hayri Fatih Metinyurt, MD, Study director, Antalya Training and Research HospitalNilgun Kavrut Ozturk, MD, Principal investigator, Antalya Training and Research HospitalAli Sait Kavakli, MD, Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190551
- Sponsor's protocol ID
- AntalyaTRH15
- Status last verified
- Jun 2017
- First submitted
- 12 Jun 2017
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- A Randomized Controlled Trial Comparing Retroclavicular and Costoclavicular Approach for Infraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT03190551
- Acronym / sponsor ID
- AntalyaTRH15
- Conditions
- Disorder of Upper Extremity
- Keywords
- infraclavicular brachial plexus block, retroclavicular approach, costoclavicular approach, upper limb surgery, needle shaft visibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Jan 2017 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 19 Jun 2017 (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.
The primary aim of this study is to compare needle shaft visibility between the retroclavicular approach and costoclavicular 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 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. This study evaluated the effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared with costoclavicular approach for infraclavicular brachial plexus block. 60 patients scheduled for elective upper limb surgery were recruited and randomized into two groups: Retroclavicular approach for infraclavicular block (Group I), costoclavicular approach for infraclavicular block (Group R). Sensory block, adverse effects and complications were evaluated and recorded every 5 minutes until 30 min 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 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 |
|---|---|---|
| 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 . |
| costoclavicular approach | Active comparator | Other: costoclavicular approachPatients in this group will be randomized to receive an costoclavicular 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 |
|---|---|---|
| retroclavicular approachRetroclavicular approach for ultrasound guided infraclavicular brachial plexus block | Other | retroclavicular approach |
| costoclavicular approachcostoclavicular approach for ultrasound guided infraclavicular brachial plexus block | Other | costoclavicular approach |
Primary outcome
Needle shaft visibility
Time frame: 10 minutes after the needle inserted the skin
Needle visibility reviewed by two anesthesiologists using a 5-point Likert scale
7 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 24 hours after the block
supplemental analgesic used
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.
- 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.
Hayri Fatih Metinyurt, MD study director
Antalya Training and Research Hospital
Nilgun Kavrut Ozturk, MD principal investigator
Antalya Training and Research Hospital
Ali Sait Kavakli, MD principal investigator
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 retroclavicular approach and costoclavicular 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 shaft 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?
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.