- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04752410
Selective Trunk Block: A Study to Evaluate Block Dynamics, Effects and Efficacy for Upper Limb Surgery
27. juli 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Kowloon
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Shatin, Kowloon, Hong Kong
- Department of Anaesthesia & Intensive Care, Prince of Wales Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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.
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes of sensory block of the upper extremity
Tidsramme: within 45 minutes after the block at 5 minutes interval
|
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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Changes of the Diaphragmatic function
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
19. februar 2021
Primær fullføring (Faktiske)
27. juli 2021
Studiet fullført (Faktiske)
27. juli 2021
Datoer for studieregistrering
Først innsendt
9. februar 2021
Først innsendt som oppfylte QC-kriteriene
9. februar 2021
Først lagt ut (Faktiske)
12. februar 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. juli 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juli 2021
Sist bekreftet
1. juli 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Updated SeTB (CREC.2020.308)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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