- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04752410
Selective Trunk Block: A Study to Evaluate Block Dynamics, Effects and Efficacy for Upper Limb Surgery
27 lipca 2021 zaktualizowane przez: Prof Manoj K Karmakar, Chinese University of Hong Kong
Selective Trunk Block: A Prospective Non-Randomized Study to Evaluate Block Dynamics, Effects on Ipsilateral Hemidiaphragmatic (Phrenic Nerve) Function and Efficacy for Upper Extremity Surgery
Brachial plexus block (BPB) is frequently used as the sole anesthetic technique for upper extremity surgery.
The choice of technique often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the technique used.
The investigator is not aware of any single BPB technique described to date that can consistently produce surgical anesthesia of the whole ipsilateral upper extremity.
However, occasionally surgery entails that the whole upper extremity, i.e. from the shoulder to the elbow, or even the forearm, wrist or hands.
This clinical challenge has been addressed previously using a combination of BPB techniques.
The investigator has recently demonstrated that it is feasible to accurately identify majority of the main components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging.
Since majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from the three trunks of the brachial plexus, the investigator hypothesized that selectively blocking upper, middle, and inferior trunks of the brachial plexus will produce surgical anesthesia of the whole ipsilateral upper extremity.
This study is a continuation of a previously approved study with title "Selective Trunk Brachial Plexus Block: A Prospective Non-Randomized Study of Intervention" [NCT04510259] after the amendment (study title, protocol and increased sample size) was rejected by local IRB and suggested to submit as a new protocol.
The aim of this study is to assess a novel brachial plexus block technique, the selective trunk block (SeTB), and provide preliminary clinical evidence of its effectiveness in producing surgical anesthesia of the whole ipsilateral upper extremity.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
Brachial plexus block (BPB) is frequently used as the sole anesthetic technique for upper extremity surgery.
The choice of technique often depends on the site of surgery because the extent of sensory-motor blockade after a BPB varies with the technique used.
The investigator is not aware of any single BPB technique described to date that can consistently produce surgical anesthesia of the whole ipsilateral upper extremity (shoulder to fingers).
However, occasionally surgery entails that the whole upper extremity is anesthetized, i.e. from the shoulder to the elbow, or even the forearm, wrist or hands.
This clinical challenge has been addressed previously using a combination of BPB (hybrid) techniques.
The investigator has recently demonstrated that it is feasible to accurately identify majority of the individual components of the brachial plexus above the clavicle, including the three trunks, using ultrasound imaging.
Since majority of the innervation of the upper extremity, i.e. shoulder, arm, elbow, forearm, wrist and hand, originates from or pass through the three trunks of the brachial plexus, the investigator hypothesized that selectively blocking the upper, middle, and inferior trunks of the brachial plexus will produce surgical anesthesia of the whole ipsilateral upper extremity, except for the area innervated by the intercostobrachial nerve (T2 - medial aspect of the upper arm).
The investigator refers this novel technique as "selective trunk block" (SeTB).
Currently there are no published data on block dynamics, safety or efficacy of SeTB.
In addition, there may be a potential advantage that phrenic nerve can be spared, so this blockade will not affect the respiratory function as it is common to see phrenic nerve palsy after interscalene BPB (100%) and supraclavicular BPB (50-67%).
This study is a continuation of a previously approved study with title "Selective Trunk Brachial Plexus Block: A Prospective Non-Randomized Study of Intervention" [NCT04510259] after the amendment (study title, protocol and increased sample size) was rejected by local IRB and suggested to submit as a new protocol.
The aim of this study is to assess a novel brachial plexus block technique, the selective trunk block (SeTB), and provide preliminary clinical evidence of its effectiveness in producing surgical anesthesia of the whole ipsilateral upper extremity.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
30
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Kowloon
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Shatin, Kowloon, Hongkong
- Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 80 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
Inclusion Criteria:
- elective upper extremity surgery
- emergency upper extremity surgery
Exclusion Criteria:
- Patient refusal
- pregnancy
- local skin site infection
- allergy to local anesthetics
- bleeding tendency
- pre-existing neurological deficit
- pre-existing neuromuscular disease.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Selective Brachial plexus block
Selective brachial plexus block will be done under ultrasound guidance to patients scheduled for upper extremity surgeries.
Local anesthetic agents (a mixture of 2% lidocaine with 1:200,000 epinephrine and 0.5% levobupivacaine in a total of 25ml) will be injected at the superior, middle, and inferior trunks of the brachial plexus in order to anesthetize the whole upper limb.
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It is one type of peripheral nerve blocks for upper extremity surgery.
In this study, the block will be done under the ultrasound guidance and the local anesthetic agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 25ml) will be injected at the trunks of the brachial plexus in order to produce the surgical anesthesia of the whole upper extremity of the patients scheduled for upper limb surgeries.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes of sensory block of the upper extremity
Ramy czasowe: within 45 minutes after the block at 5 minutes interval
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Sensation to coldness (ice) will be tested at the median (lateral three and half digits on the palmar side), radial (dorsal side of hand), ulnar (medial one and a half digits), musculocutaneous (lateral side of the forearm) and axillary (skin over the lower deltoid) and graded using a verbal rating scale (VRS:0-100, 100=normal sensation, 0=no sensation).
Onset of sensory block for each nerve will be defined as the time that it took to achieve a sensory block score of =<30.
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within 45 minutes after the block at 5 minutes interval
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Changes of motor block of the upper extremity
Ramy czasowe: within 45 minutes after the block at 5 minutes interval
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Motor blockade will be graded using a 3-points scale revising from previous study: 2=no block, 1=paresis and 0=paralysis.
Motor blockade of each individual nerve in the anesthetized upper extremity will be evaluated by testing for opposition of thumb with the index finger (median nerve), wrist extension (radial nerve), thumb opposition with little finger (ulnar nerve), elbow flexion (musculocutaneous nerve) abduction of shoulder (axillary nerve), and external rotation of the arm with elbow flexed and simulate emptying a can motion and test for power against resistance (Suprascapular nerve).
The onset of motor block for each nerve will be defined as motor grading at each nerve =<1.
Complete block will be defined as a sensory and motor block score of '0' in all nerves functions.
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within 45 minutes after the block at 5 minutes interval
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Readiness for surgery
Ramy czasowe: within 45 minutes after the block at 5 minutes interval
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overall sensory scores =<30 (VRS: 0-100, 100=normal sensation, 0=no sensation) and motor score =<1 (3-points scale, 2=no block, 1=paresis, 0=paralysis) in all the nerves tested.
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within 45 minutes after the block at 5 minutes interval
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Changes of the Diaphragmatic function
Ramy czasowe: Baseline (before brachial plexus block) and at 30 minutes after block
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Excursion of the right hemidiaphragm will be measured by ultrasound machine in supine position via the anterior subcostal route.
The movement of the diaphragm will be measured in centimetres.
The range of diaphragmatic excursion will be recorded from the resting expiratory position to deep inspiration (sigh test) as will be range of diaphragmatic movement from resting expiratory position when quickly inspiring through the nose (sniff test).
The decrease in diaphragmatic excursion will be calculated as the difference (in percentage) in diaphragmatic excursion measured before and 30 minutes after SeTB.
Reduction in diaphragmatic excursion of more than 75% of baseline, or no movement, or paradoxical movement will be considered as complete paresis.
Reduction in diaphragmatic excursion of between 25% and 75% will be considered as partial paresis and diaphragmatic excursion of less than 25% will be considered as 'no paresis'.
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Baseline (before brachial plexus block) and at 30 minutes after block
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Współpracownicy i badacze
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Sponsor
Publikacje i pomocne linki
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Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
19 lutego 2021
Zakończenie podstawowe (Rzeczywisty)
27 lipca 2021
Ukończenie studiów (Rzeczywisty)
27 lipca 2021
Daty rejestracji na studia
Pierwszy przesłany
9 lutego 2021
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 lutego 2021
Pierwszy wysłany (Rzeczywisty)
12 lutego 2021
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
28 lipca 2021
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
27 lipca 2021
Ostatnia weryfikacja
1 lipca 2021
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Updated SeTB (CREC.2020.308)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .