Brachial Plexus BlockNCT03484247
Injection Optimization of Infraclavicular and Axillary Brachial Plexus Block
A study testing Infraclavicular brachial plexus block and axillary brachial plexus block in people with Brachial Plexus Block, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In upper extremity surgery, brachial plexus block (BPB) is routinely applied successfully as general anesthesia (GA). However, BPB is less invasive technique than GA. Peripheral nerve blocks have some potential benefits, such as lower risk of nausea and vomiting, early ambulation, early discharge, and better control… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brachial Plexus Block
- What is being tested?
- Infraclavicular brachial plexus block and axillary brachial plexus block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Apr 2018to 1 Jul 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Axillary or infraclavicular brachial plexus block who underwent forearm or hand surgery
- ASA score I-II-III
- Body weight> 45 kg or BMI <40 kg / m2
Who cannot join
- Under 18 years old or over 75 years old
- Body weight <45 kg or BMI> 40 kg / m2
- ASA score above III
- Pregnant or lactating
- Coagulopathy or anticoagulant medication
- Allergies about using local anesthetic drugs
- Neurological deficit
- Renal insufficiency or liver failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Injection Optimization of Infraclavicular and Axillary Brachial Plexus Block: Comparison of Number of Attempts and Performance Time
In upper extremity surgery, brachial plexus block (BPB) is routinely applied successfully as general anesthesia (GA). However, BPB is less invasive technique than GA. Peripheral nerve blocks have some potential benefits, such as lower risk of nausea and vomiting, early ambulation, early discharge, and better control of postoperative pain. The BPB is applied to various areas such as axillary, supraclavicular, infraclavicular and interscalene areas under the guidance of ultrasound and nerve stimulator. Among these methods, BPB administration success rates are around 95-100%. The other condition is anesthetic time which is important for the turnover of operating room. Anesthetic time is the sum of the performance time and onset time. In addition performance time and number of needle attempts also associated with patient satisfaction. The primary aim of this study is to determine the number of attempts and the performance time with the onset time and anesthetic time. If the procedure is simple, the performance time may be shorter. Therefore, the investigators aim that comparison of two different procedures which are single injection infraclavicular brachial plexus block and multiple injection axillary brachial plexus block by ultrasound guidance. In addition, the investigators will examine the duration of anesthesia and surgery, the duration of sensory and motor block endings, patient comfort and pain scales in the postoperative period.
Read the detailed description
60 participants who underwent forearm or hand surgery with the axillary or infraclavicular brachial plexus block method and who have an American Society of Anesthesiologists physical status classification (ASA) score of I-II-III between the ages of 18-75 will be followed up. Number of needle attempts, block performance time, sensorial and motor block onset time, total anesthetic time, surgical duration, duration of sensory block formation, and duration of motor block formation will be evaluated with the information obtained from participants with axillary block or infraclavicular block. After surgery, participants satisfaction, visual analogue scales (VAS), sensory block ending times, motor block ending times and first analgesic requirement time will be assessed at postoperative 2. -8. -12. -24. hours by physical examination and questions. As a result of these evaluations, both groups will be compared statistically. (After the patients are informed in detail, the volunteer certificate will be obtained from the patients who agree to participate in the study.)
- Conditions
- Brachial Plexus Block
- Being tested
- Infraclavicular brachial plexus block, axillary brachial plexus block
- Keywords
- infraclavicular block, axillary block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infraclavicular brachial plexus blockOther
Infraclavicular block will be performed with ultrasound guidance and peripheric nerve stimulator. Local anesthetic will be administered after aspiration, via peripheric nerve needle according to mentioned technique ( https://www.nysora.com/)
axillary brachial plexus blockOther
Axillary nerve block will be performed with ultrasound guidance and peripheric nerve stimulator. Local anesthetic will be administered after aspiration via peripheric nerve needle according to mentioned technique ( https://www.nysora.com/)
| Study group | Role | What they receive |
|---|---|---|
| Group Infraclavicular | Active comparator | Infraclavicular Brachial Plexus Block: The inferolateral of the subclavian artery will be targeted with a 85 mm peripheral nerve stimulator needle with ultrasound guidance. When the needle tip was seen near the posterior cord of brachial plexus local anesthetic will be administered with single injection after aspiration. Receives: Other: Infraclavicular brachial plexus block |
| Group Axillary | Active comparator | Axillary Brachial Plexus Block: The procedure will be performed with a 50 mm peripheral nerve stimulator needle with ultrasound guidance. Local anesthetic will be administered with multiple injection (radial, ulnar, median and musculocutaneous nerves) after aspiration. Receives: Other: axillary brachial plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to brachial plexus block performance
performance time will hold with a stopwatch
Measured: from the first second of brachial plexus imaging with ultrasound until the needle remove from the skin will be assessed up to ten minutes
Secondary outcomes (2)
number of needle attempt
number of needle attempt will be count during the procedure
Measured: during the procedure
time to brachial plexus block onset
nerves will have sensorial and motor examination
Measured: after end of the procedure 5th, 10th, 15th, 20th, 25th, 30th minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start6 Apr 2018
- Primary completion1 Jun 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus BlockStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sevtap Cemaloglu, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484247
- Sponsor's protocol ID
- sevtap 1
- Status last verified
- Jul 2018
- First submitted
- 12 Mar 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Optimization of Infraclavicular and Axillary Brachial Plexus Block: Comparison of Number of Attempts and Performance Time
- ClinicalTrials.gov ID
- NCT03484247
- Acronym / sponsor ID
- sevtap 1
- Conditions
- Brachial Plexus Block
- Keywords
- infraclavicular block, axillary block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 6 Apr 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 30 Mar 2018 (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.
In upper extremity surgery, brachial plexus block (BPB) is routinely applied successfully as general anesthesia (GA). However, BPB is less invasive technique than GA. Peripheral nerve blocks have some potential benefits, such as lower risk of nausea and vomiting, early ambulation, early discharge, and better control of postoperative pain. The BPB is applied to various areas such as axillary, supraclavicular, infraclavicular and interscalene areas under the guidance of ultrasound and nerve stimulator. Among these methods, BPB administration success rates are around 95-100%. The other condition is anesthetic time which is important for the turnover of operating room. Anesthetic time is the sum of the performance time and onset time. In addition performance time and number of needle attempts also associated with patient satisfaction. The primary aim of this study is to determine the number of attempts and the performance time with the onset time and anesthetic time. If the procedure is simple, the performance time may be shorter. Therefore, the investigators aim that comparison of two different procedures which are single injection infraclavicular brachial plexus block and multiple injection axillary brachial plexus block by ultrasound guidance. In addition, the investigators will examine the duration of anesthesia and surgery, the duration of sensory and motor block endings, patient comfort and pain scales in the postoperative period.
Detailed description
60 participants who underwent forearm or hand surgery with the axillary or infraclavicular brachial plexus block method and who have an American Society of Anesthesiologists physical status classification (ASA) score of I-II-III between the ages of 18-75 will be followed up. Number of needle attempts, block performance time, sensorial and motor block onset time, total anesthetic time, surgical duration, duration of sensory block formation, and duration of motor block formation will be evaluated with the information obtained from participants with axillary block or infraclavicular block. After surgery, participants satisfaction, visual analogue scales (VAS), sensory block ending times, motor block ending times and first analgesic requirement time will be assessed at postoperative 2. -8. -12. -24. hours by physical examination and questions. As a result of these evaluations, both groups will be compared statistically. (After the patients are informed in detail, the volunteer certificate will be obtained from the patients who agree to participate in the study.)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Infraclavicular | Active comparator | Other: Infraclavicular brachial plexus blockInfraclavicular Brachial Plexus Block: The inferolateral of the subclavian artery will be targeted with a 85 mm peripheral nerve stimulator needle with ultrasound guidance. When the needle tip was seen near the posterior cord of brachial plexus local anesthetic will be administered with single injection after aspiration. |
| Group Axillary | Active comparator | Other: axillary brachial plexus blockAxillary Brachial Plexus Block: The procedure will be performed with a 50 mm peripheral nerve stimulator needle with ultrasound guidance. Local anesthetic will be administered with multiple injection (radial, ulnar, median and musculocutaneous nerves) after aspiration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Axillary or infraclavicular brachial plexus block who underwent forearm or hand surgery
- ASA score I-II-III
- Body weight> 45 kg or BMI <40 kg / m2
Key exclusion criteria (8 listed)
- Under 18 years old or over 75 years old
- Body weight <45 kg or BMI> 40 kg / m2
- ASA score above III
- Pregnant or lactating
- Coagulopathy or anticoagulant medication
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 |
|---|---|---|
| Infraclavicular brachial plexus blockInfraclavicular block will be performed with ultrasound guidance and peripheric nerve stimulator. Local anesthetic will be administered after aspiration, via peripheric nerve needle according to mentioned technique ( https://www.nysora.com/) | Other | Group Infraclavicular |
| axillary brachial plexus blockAxillary nerve block will be performed with ultrasound guidance and peripheric nerve stimulator. Local anesthetic will be administered after aspiration via peripheric nerve needle according to mentioned technique ( https://www.nysora.com/) | Other | Group Axillary |
Primary outcome
time to brachial plexus block performance
Time frame: from the first second of brachial plexus imaging with ultrasound until the needle remove from the skin will be assessed up to ten minutes
performance time will hold with a stopwatch
2 secondary outcomes
number of needle attempt
Time frame: during the procedure
time to brachial plexus block onset
Time frame: after end of the procedure 5th, 10th, 15th, 20th, 25th, 30th minutes
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 27 Jul 2018.
Related trials for Brachial Plexus Block
RecruitingObservational study
Pulse Wave Transit Time After Infraclavicular Block
Infraclavicular Brachial Plexus Block
RecruitingPhase 3
Liposomal Bupivacaine Plus Plain Bupivacaine Versus Dexamethasone Plus Plain Bupivacaine in the Supraclavicular Brachial Plexus Block in Patients With Risk Factors for Severe Acute Postoperative Pain
Pain, Postoperative, Liposomal Bupivacaine
RecruitingPhase 4
Minimal Effective Volume 90% for Double-injection Costoclavicular Block
Brachial Plexus Blocks, Lidocaine
Not yet recruitingPhase 4
Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery
Hemidiaphragmatic Paralysis, Postoperative Pain
Recruiting
Comparison Between Ultrasound-Guided Costoclavicular and Lateral-Sagittal Infraclavicular Brachial Plexus Blocks in Adult Distal Upper Limb Surgeries
Regional Anesthesia Block, Brachial Plexus Blocks
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infraclavicular brachial plexus block and axillary brachial plexus block in people with Brachial Plexus Block, run by Diskapi Yildirim Beyazit Education 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 8 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 27 Jul 2018. 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?
time to brachial plexus block performance (time frame: from the first second of brachial plexus imaging with ultrasound until the needle remove from the skin will be assessed up to ten minutes). 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 27 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.