Upper Extremity ProblemNCT06004648
Comparison of Selective Trunk and Supraclavicular Brachial Plexus Blocks
An observational study of Upper Extremity Problem, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
There are different methods in brachial plexus blocks for hand, wrist, forearm, and elbow operations. In this study, the anesthetic efficacy of the ultrasound-guided selective truncus methods and the supraclavicular methods for brachial plexus blocks in upper extremity surgeries will be compared. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Extremity Problem
- What is being tested?
- Upper extremity surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2022to 10 Jan 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthopedic surgery patients between 18-65 years of age who needs upper extremity elbow and below-elbow surgery
Who may be able to join
- Patients undergoing upper extremity elbow and below-elbow surgery in the orthopedics and traumatology operating room
Who cannot join
- Patient's refusal
- ASA IV,
- Pregnancy,
- Neuromuscular disease,
- Peripheral neuropathy
- Bleeding disorders,
Show all 9Show fewer
- Local anesthetic allergy,
- Infection in the block area
- Operations without using a tourniquet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Anesthetic and Analgesic Efficacy of Selective Trunk and Supraclavicular Brachial Plexus Blocks in Upper Extremity Surgery
There are different methods in brachial plexus blocks for hand, wrist, forearm, and elbow operations. In this study, the anesthetic efficacy of the ultrasound-guided selective truncus methods and the supraclavicular methods for brachial plexus blocks in upper extremity surgeries will be compared.
Read the detailed description
Currently, brachial plexus block performed with various approaches is preferred to general anesthesia due to its advantages in upper extremity surgeries. These advantages can be listed as protecting the patient's consciousness, minimum effect on breathing, reducing airway interventions, enabling long-term postoperative pain control, reducing opioid-related side effects, limiting metabolic and endocrine changes due to surgery, and early discharge of hospital. The supraclavicular approach has a rapid onset of block and a high success rate. Close proximity to the pleura is the main disadvantage, but the widespread use of USG in peripheral blocks has also reduced the risk of complications related to this proximity. In the selective truncus approach defined by Manoj Kumar Karmakar in 2020, three trunks of the brachial plexus can be identified separately and selectively blocked under ultrasound guidance. It has been suggested that sensory/motor block occurs in all ipsilateral upper extremity dermatomes except T2 by selective blocking of the upper, middle, and lower trunks. In this study, the selective trunk method and the supraclavicular method will be compared.
Patients who will undergo upper extremity elbow and below-elbow surgery in the orthopedics and traumatology operating room will be included in the study. The primary aim of the study is to compare the success rates of supraclavicular and selective truncus blocks in patients scheduled for hand, wrist, forearm, and elbow surgery. Comparisons will be made by measuring the first analgesic time after surgery. Secondary aims are sensory and motor block success rates between the two methods. The block application time, preparation time for surgery, number of needle insertions, tourniquet pain, diaphragmatic paralysis rate, complications (vascular puncture, paresthesia, horner's syndrome, hoarseness, local anesthetic toxicity, pneumothorax) patient satisfaction, surgeon satisfaction and total analgesic amount at the end of the postoperative 12 and 24 hours will be recorded.
- Conditions
- Upper Extremity Problem
- Being tested
- Upper extremity surgery
- Keywords
- nerve block, Pain, Postoperative, Anesthetics, Local
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper extremity surgeryProcedure or surgery
Comparison of 2 different peripheral nerve blocks
| Study group | Role | What they receive |
|---|---|---|
| Supraclavicular nerve block | The high- frequency linear USG probe will be placed in the supraclavicular fossa pointing caudally, and the subclavian artery will be localized by moving it medially and laterally. A characteristic honeycomb plexus will be visualized in the lateral and superficial subclavian artery. Vascular structures will be detected using color Doppler, the first rib will be visualized as hyperechoic structure. After the pleura, which makes a
sliding movement through the patient\'s breathing is detected, a 22 gauge, 80 mm scale peripheral block needle will be directed from the lateral to the medial by an in-plane technique. After the sheath punctured, nerves will be determined with triceps, biceps, and wrist motor activity by using a nerve stimulator, and then 15 ml of 0.5% bupivacaine will be injected between the 1st rib and the lower trunk. Receives: Procedure: Upper extremity surgery | |
| Selective Trunk Block | Sequential ultrasound imaging technique (SUIT) will be used which is shown successfully in identifying individual elements of the brachial plexus. The neural complex of the upper trunk, middle trunk, and C8 ventral ramus, which are superficial to the T1 TP-1.rip complex will be defined. The first injections contains 8 ml and 7 ml 0.5% bupivacaine will be made as, close to the upper trunk(8ml) and middle trunk(7ml) in the interscalene groove. Then the needle will be completely withdrawn.The ultrasound probe will be placed caudally in the supraclavicular fossa. After providing the optimal view of the lower trunk in the corner pocket, 10 ml of 0.5% bupivacaine will be injected between the first rib and lower trunk. Receives: Procedure: Upper extremity surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
peripheral block success
primary aim of the study is to compare the success rates of supraclavicular and selective truncus blocks in patients scheduled for hand, wrist, forearm, and elbow surgery. Comparison will be made by measuring the first analgesic time after surgery.
Measured: T1: 12 hours after surgery, T2: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start28 Jul 2022
- Primary completion10 Jan 2023
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity ProblemStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Döndü Genc Moralar, Gaziosmanpasa Research and Education Hospital
- Investigators
- ZÜHAL ÇAVUŞ, Study chair, gaziosmanpasa TREH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004648
- Sponsor's protocol ID
- 107
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Anesthetic and Analgesic Efficacy of Selective Trunk and Supraclavicular Brachial Plexus Blocks in Upper Extremity Surgery
- ClinicalTrials.gov ID
- NCT06004648
- Acronym / sponsor ID
- 107
- Conditions
- Upper Extremity Problem
- Keywords
- nerve block, Pain, Postoperative, Anesthetics, Local
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 22 Aug 2023 (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.
There are different methods in brachial plexus blocks for hand, wrist, forearm, and elbow operations. In this study, the anesthetic efficacy of the ultrasound-guided selective truncus methods and the supraclavicular methods for brachial plexus blocks in upper extremity surgeries will be compared.
Detailed description
Currently, brachial plexus block performed with various approaches is preferred to general anesthesia due to its advantages in upper extremity surgeries. These advantages can be listed as protecting the patient's consciousness, minimum effect on breathing, reducing airway interventions, enabling long-term postoperative pain control, reducing opioid-related side effects, limiting metabolic and endocrine changes due to surgery, and early discharge of hospital. The supraclavicular approach has a rapid onset of block and a high success rate. Close proximity to the pleura is the main disadvantage, but the widespread use of USG in peripheral blocks has also reduced the risk of complications related to this proximity. In the selective truncus approach defined by Manoj Kumar Karmakar in 2020, three trunks of the brachial plexus can be identified separately and selectively blocked under ultrasound guidance. It has been suggested that sensory/motor block occurs in all ipsilateral upper extremity dermatomes except T2 by selective blocking of the upper, middle, and lower trunks. In this study, the selective trunk method and the supraclavicular method will be compared.
Patients who will undergo upper extremity elbow and below-elbow surgery in the orthopedics and traumatology operating room will be included in the study. The primary aim of the study is to compare the success rates of supraclavicular and selective truncus blocks in patients scheduled for hand, wrist, forearm, and elbow surgery. Comparisons will be made by measuring the first analgesic time after surgery. Secondary aims are sensory and motor block success rates between the two methods. The block application time, preparation time for surgery, number of needle insertions, tourniquet pain, diaphragmatic paralysis rate, complications (vascular puncture, paresthesia, horner's syndrome, hoarseness, local anesthetic toxicity, pneumothorax) patient satisfaction, surgeon satisfaction and total analgesic amount at the end of the postoperative 12 and 24 hours will be recorded.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supraclavicular nerve block | – | Procedure: Upper extremity surgeryThe high- frequency linear USG probe will be placed in the supraclavicular fossa pointing caudally, and the subclavian artery will be localized by moving it medially and laterally. A characteristic honeycomb plexus will be visualized in the lateral and superficial subclavian artery. Vascular structures will be detected using color Doppler, the first rib will be visualized as hyperechoic structure. After the pleura, which makes a sliding movement through the patient\'s breathing is detected, a 22 gauge, 80 mm scale peripheral block needle will be directed from the lateral to the medial by an in-plane technique. After the sheath punctured, nerves will be determined with triceps, biceps, and wrist motor activity by using a nerve stimulator, and then 15 ml of 0.5% bupivacaine will be injected between the 1st rib and the lower trunk. |
| Selective Trunk Block | – | Procedure: Upper extremity surgerySequential ultrasound imaging technique (SUIT) will be used which is shown successfully in identifying individual elements of the brachial plexus. The neural complex of the upper trunk, middle trunk, and C8 ventral ramus, which are superficial to the T1 TP-1.rip complex will be defined. The first injections contains 8 ml and 7 ml 0.5% bupivacaine will be made as, close to the upper trunk(8ml) and middle trunk(7ml) in the interscalene groove. Then the needle will be completely withdrawn.The ultrasound probe will be placed caudally in the supraclavicular fossa. After providing the optimal view of the lower trunk in the corner pocket, 10 ml of 0.5% bupivacaine will be injected between the first rib and lower trunk. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopedic surgery patients between 18-65 years of age who needs upper extremity elbow and below-elbow surgery
Key inclusion criteria (1 listed)
- Patients undergoing upper extremity elbow and below-elbow surgery in the orthopedics and traumatology operating room
Key exclusion criteria (9 listed)
- Patient's refusal
- ASA IV,
- Pregnancy,
- Neuromuscular disease,
- Peripheral neuropathy
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 |
|---|---|---|
| Upper extremity surgeryComparison of 2 different peripheral nerve blocks | Procedure or surgery | Selective Trunk Block, Supraclavicular nerve block |
Primary outcome
peripheral block success
Time frame: T1: 12 hours after surgery, T2: 24 hours after surgery
primary aim of the study is to compare the success rates of supraclavicular and selective truncus blocks in patients scheduled for hand, wrist, forearm, and elbow surgery. Comparison will be made by measuring the first analgesic time after surgery.
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 22 Aug 2023.
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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.
ZÜHAL ÇAVUŞ study chair
gaziosmanpasa TREH
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 Upper Extremity Problem, run by Gaziosmanpasa Research and Education 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 1 inclusion and 9 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 22 Aug 2023. 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?
peripheral block success (time frame: T1: 12 hours after surgery, T2: 24 hours after surgery). 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 22 Aug 2023.