Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block

NCT03577860 | Unknown DMC

• 1 other identifier: 48739315.4.0000.5505
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with indication of shoulder surgery will be submitted to ultrasound-guided interscalene brachial plexus block with 4ml or 15ml of bupivacaine- epinephrine 0,5%- 1:200,000 at level of C5-6 roots and will be evaluated their ventilation and pulmonary aeration by electrical impedance tomography

Conditions

Brachial Plexus Block; Pulmonary Ventilation

Outcome Measures

Primary Outcomes (1)

• Variation of pulmonary function

  Evaluation of variation of pulmonary aeration and ventilation after interscalene brachial plexus block with 4ml or 15 ml of bupivacaine- epinephrine 0,5%1:200,0000. The pulmonary function will be evaluated by electrical impedance tomography.

  4 hour

Secondary Outcomes (2)

• Opioid consumption

  24 hours

• Post-Operative pain

  24 hours

Study Arms (2)

Bupivacaine 4ml

ACTIVE COMPARATOR

The interscalene brachial plexus block is performed with 4ml at level of C5-6 roots

Drug: Bupivacaine 4 mL

Bupivacaine 15ml

ACTIVE COMPARATOR

The interscalene brachial plexus block is performed with 15ml at level of C5-6

Drug: Bupivacaine 15 mL

Interventions

Bupivacaine 4 mL DRUG

The interscalene brachial plexus block is performed with 4ml of bupivacaine-epinephrine 0,5%- 1:200,000

Bupivacaine 4ml

Bupivacaine 15 mL DRUG

The interscalene brachial plexus block is performed with 15ml of bupivacaine-epinephrine 0,5%- 1:200,000

Bupivacaine 15ml

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• shoulder surgery
• indication of interscalene brachial plexus block
• American Society of Anesthesiology Physical Status Classification I or II

You may not qualify if:

• refuse to participate
• previous lung or diaphragma surgeries

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (2)

Federal University of Sao Paulo

São Paulo, 04024-002, Brazil

RECRUITING

Federal University of Sao Paulo - Hospital Sao Paulo

São Paulo, 04024002, Brazil

RECRUITING

Related Publications (10)

• Sinha SK, Abrams JH, Weller RS. Ultrasound-guided interscalene needle placement produces successful anesthesia regardless of motor stimulation above or below 0.5 mA. Anesth Analg. 2007 Sep;105(3):848-52. doi: 10.1213/01.ane.0000271912.84440.01.

  PMID: 17717249 RESULT

• Riazi S, Carmichael N, Awad I, Holtby RM, McCartney CJ. Effect of local anaesthetic volume (20 vs 5 ml) on the efficacy and respiratory consequences of ultrasound-guided interscalene brachial plexus block. Br J Anaesth. 2008 Oct;101(4):549-56. doi: 10.1093/bja/aen229. Epub 2008 Aug 4.

  PMID: 18682410 RESULT

• Gautier P, Vandepitte C, Ramquet C, DeCoopman M, Xu D, Hadzic A. The minimum effective anesthetic volume of 0.75% ropivacaine in ultrasound-guided interscalene brachial plexus block. Anesth Analg. 2011 Oct;113(4):951-5. doi: 10.1213/ANE.0b013e31822b876f. Epub 2011 Aug 4.

  PMID: 21821517 RESULT

• Urmey WF, Talts KH, Sharrock NE. One hundred percent incidence of hemidiaphragmatic paresis associated with interscalene brachial plexus anesthesia as diagnosed by ultrasonography. Anesth Analg. 1991 Apr;72(4):498-503. doi: 10.1213/00000539-199104000-00014.

  PMID: 2006740 RESULT

• Urmey WF, McDonald M. Hemidiaphragmatic paresis during interscalene brachial plexus block: effects on pulmonary function and chest wall mechanics. Anesth Analg. 1992 Mar;74(3):352-7. doi: 10.1213/00000539-199203000-00006.

  PMID: 1539813 RESULT

• Renes SH, van Geffen GJ, Rettig HC, Gielen MJ, Scheffer GJ. Minimum effective volume of local anesthetic for shoulder analgesia by ultrasound-guided block at root C7 with assessment of pulmonary function. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):529-34. doi: 10.1097/AAP.0b013e3181fa1190.

  PMID: 20975468 RESULT

• Urmey WF, Gloeggler PJ. Pulmonary function changes during interscalene brachial plexus block: effects of decreasing local anesthetic injection volume. Reg Anesth. 1993 Jul-Aug;18(4):244-9.

  PMID: 8398959 RESULT

• Gottardis M, Luger T, Florl C, Schon G, Penz T, Resch H, Benzer A. Spirometry, blood gas analysis and ultrasonography of the diaphragm after Winnie's interscalene brachial plexus block. Eur J Anaesthesiol. 1993 Sep;10(5):367-9.

  PMID: 11767428 RESULT

• Hortense A, Perez MV, Amaral JL, Oshiro AC, Rossetti HB. Interscalene brachial plexus block. Effects on pulmonary function. Rev Bras Anestesiol. 2010 Mar-Apr;60(2):130-7, 74-8. doi: 10.1016/s0034-7094(10)70017-9. English, Portuguese, Spanish.

  PMID: 20485957 RESULT

• 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.

  PMID: 19920426 RESULT

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Leonardo HC Ferraro, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leonardo HC Ferraro, PhD

CONTACT

+5511999516103; leohcferraro@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: July 5, 2018
• Study Start: May 17, 2018
• Primary Completion: October 17, 2018
• Study Completion: December 17, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)