- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01244932
Minimum Effective Volume of Local Anesthetic Using Ultrasound for Brachial Plexus Block
Determination of the Minimum Effective Volume of Local Anesthetic Using Ultrasound Guidance for Interscalene Brachial Plexus Block
연구 개요
상세 설명
This will be a single group assignment, double-blind, up-down sequential allocation study. Interscalene brachial plexus block (ISBPB) is a common nerve block given to patients who are undergoing shoulder surgery. This block has a low, but still significant, rate of complications. Reducing the volume of local anesthetic given during the block may allow some of these complications to be avoided. Participants will undergo ISBPB under ultrasound and nerve stimulator guidance. Patients will initially receive 15mL of local anesthetic (bupivacaine 0.5% with epinephrine). The volume used for each subsequent patient depends upon the success or failure of the previous patient's block - a failure will cause the volume given to increase by 1.0 mL, while a success will cause the volume to decrease by the same amount.
The goal of this study is to determine the minimum effective anesthetic volume of bupivacaine 0.5% providing anesthesia in patients when using ultrasound and nerve stimulator to guide placement of the block. The secondary outcome will be the evaluation of diaphragmatic function and post-surgery analgesia.
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
SP
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Sao Paulo, SP, 브라질
- Luiz Fernando dos Reis Falcao
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients receiving interscalene brachial plexus block for shoulder surgery
- Age between 21 and 65 years
- ASA physical status I/II
- Body mass index < 35 kg/m2
Exclusion Criteria:
- Chronic obstructive pulmonary disease
- Psychiatric history
- Allergy to bupivacaine
- Infection in the site of block
- Coagulation disorders
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 삼루타
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
ED95 of bupivacaine minimum effective volume
기간: ED95
|
The ED95 of bupivacaine minimum effective volume determination in interscalene brachial plexus block using ultrasound guidance.
[ Time Frame: every 10 minutes until 30 minutes, after 4 hours and after 6 hours post-block ]
|
ED95
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Diaphragmatic Function
기간: Diaphragmatic
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Diaphragmatic Function (as assessed by diaphragmatic movement on ultrasound) [ Time Frame: after 30 minutes, 4 hours and 6 hours post-block ]
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Diaphragmatic
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Post-surgery analgesia
기간: Analgesia
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Post-surgery analgesia [ Time Frame: after 4 hours and 6 hours post-block ]
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Analgesia
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Luiz Fernando Falcao, MD, Federal University of São Paulo
간행물 및 유용한 링크
일반 간행물
- Duggan E, El Beheiry H, Perlas A, Lupu M, Nuica A, Chan VW, Brull R. Minimum effective volume of local anesthetic for ultrasound-guided supraclavicular brachial plexus block. Reg Anesth Pain Med. 2009 May-Jun;34(3):215-8. doi: 10.1097/AAP.0b013e31819a9542.
- Ponrouch M, Bouic N, Bringuier S, Biboulet P, Choquet O, Kassim M, Bernard N, Capdevila X. Estimation and pharmacodynamic consequences of the minimum effective anesthetic volumes for median and ulnar nerve blocks: a randomized, double-blind, controlled comparison between ultrasound and nerve stimulation guidance. Anesth Analg. 2010 Oct;111(4):1059-64. doi: 10.1213/ANE.0b013e3181eb6372. Epub 2010 Aug 12.
- O'Donnell BD, Iohom G. An estimation of the minimum effective anesthetic volume of 2% lidocaine in ultrasound-guided axillary brachial plexus block. Anesthesiology. 2009 Jul;111(1):25-9. doi: 10.1097/ALN.0b013e3181a915c7.
- Gupta PK, Pace NL, Hopkins PM. Effect of body mass index on the ED50 volume of bupivacaine 0.5% for supraclavicular brachial plexus block. Br J Anaesth. 2010 Apr;104(4):490-5. doi: 10.1093/bja/aeq017. Epub 2010 Feb 18.
- Renes SH, Rettig HC, Gielen MJ, Wilder-Smith OH, van Geffen GJ. Ultrasound-guided low-dose interscalene brachial plexus block reduces the incidence of hemidiaphragmatic paresis. Reg Anesth Pain Med. 2009 Sep-Oct;34(5):498-502. doi: 10.1097/AAP.0b013e3181b49256.
- Marhofer P, Eichenberger U, Stockli S, Huber G, Kapral S, Curatolo M, Kettner S. Ultrasonographic guided axillary plexus blocks with low volumes of local anaesthetics: a crossover volunteer study. Anaesthesia. 2010 Mar;65(3):266-71. doi: 10.1111/j.1365-2044.2010.06247.x. Epub 2010 Jan 29.
- Farquhar-Thomson DR, Baker AK, Satapathy AR, Coventry D, Harper GK, Stafford MA, Hill DA. Minimum volume of local anaesthetic required for an axillary brachial plexus block. Br J Anaesth. 2010 Sep;105(3):382-3. doi: 10.1093/bja/aeq220. No abstract available.
- Harper GK, Stafford MA, Hill DA. Minimum volume of local anaesthetic required to surround each of the constituent nerves of the axillary brachial plexus, using ultrasound guidance: a pilot study. Br J Anaesth. 2010 May;104(5):633-6. doi: 10.1093/bja/aeq050. Epub 2010 Mar 16. Erratum In: Br J Anaesth. 2010 Sep;105(3):392. Dosage error in article text.
- Smith HM, Duncan CM, Hebl JR. Clinical utility of low-volume ultrasound-guided interscalene blockade: contraindications reconsidered. J Ultrasound Med. 2009 Sep;28(9):1251-8. doi: 10.7863/jum.2009.28.9.1251.
- Falcao LF, Perez MV, de Castro I, Yamashita AM, Tardelli MA, Amaral JL. Minimum effective volume of 0.5% bupivacaine with epinephrine in ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2013 Mar;110(3):450-5. doi: 10.1093/bja/aes419. Epub 2012 Nov 29.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UNIFESP-01
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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