Clinical trial NCT03577860: Ventilation and Pulmonary Aeration, Electrical Impedance Tomography, Interscalene Brachial Plexus Block
Official title: Evaluation of Variation of Ventilation and Pulmonary Aeration Using Electrical Impedance Tomography in Patients With Interscalene Brachial Plexus Block for Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brachial Plexus Block
Pulmonary Ventilation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion criteria:

* refuse to participate
* previous lung or diaphragma surgeries

Primary outcomes:
measure: Variation of pulmonary function
timeFrame: 4 hour
Secondary outcomes:
measure: Opioid consumption
timeFrame: 24 hours
measure: Post-Operative pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo - Hospital Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Leonardo HC Ferraro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.