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Selective Trunk Block: A Study to Evaluate Block Dynamics, Effects and Efficacy for Upper Limb Surgery

2021년 7월 27일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

중재적

등록 (실제)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Kowloon
      • Shatin, Kowloon, 홍콩
        • Department of Anaesthesia & Intensive Care, Prince of Wales Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른 이름들:
  • 의약품

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Changes of sensory block of the upper extremity
기간: 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.
within 45 minutes after the block at 5 minutes interval
Changes of motor block of the upper extremity
기간: within 45 minutes after the block at 5 minutes interval
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.
within 45 minutes after the block at 5 minutes interval
Readiness for surgery
기간: within 45 minutes after the block at 5 minutes interval
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.
within 45 minutes after the block at 5 minutes interval

2차 결과 측정

결과 측정
측정값 설명
기간
Changes of the Diaphragmatic function
기간: Baseline (before brachial plexus block) and at 30 minutes after block
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'.
Baseline (before brachial plexus block) and at 30 minutes after block

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 2월 19일

기본 완료 (실제)

2021년 7월 27일

연구 완료 (실제)

2021년 7월 27일

연구 등록 날짜

최초 제출

2021년 2월 9일

QC 기준을 충족하는 최초 제출

2021년 2월 9일

처음 게시됨 (실제)

2021년 2월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 7월 28일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 7월 27일

마지막으로 확인됨

2021년 7월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Updated SeTB (CREC.2020.308)

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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