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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Local Anesthesia in Dentistry | Study protocol

Rationale and design of PASSAT — patients’ satisfaction with local or general anaesthesia in video-assisted thoracoscopic surgery: study protocol for a randomised controlled trial with a non-randomised side arm

Authors: Thomas Galetin, Pascal Bretzke, Alberto Lopez-Pastorini, Mark Schieren, Aris Koryllos, Nils Kosse, Jost Schnell, Jerome M. Defosse, Frank Wappler, Erich Stoelben

Published in: Trials | Issue 1/2019

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Abstract

Background

Although general anaesthesia (GA) with one-lung ventilation is the current standard of care, minor thoracoscopic surgery, i.e. treatment of pleural effusions, biopsies and small peripheral pulmonary wedge resections, can also be performed using local anaesthesia (LA), analgosedation and spontaneous breathing. Whilst the feasibility and safety of LA have been demonstrated, its impact on patient satisfaction remains unclear. Most studies evaluating patient satisfaction lack control groups or do not meet psychometric criteria. We report the design of the PASSAT trial (PAtientS’ SATisfaction in thoracic surgery – general vs. local anaesthesia), a randomised controlled trial with a non-randomised side arm.

Methods

Patients presenting for minor thoracoscopic surgery and physical eligibility for GA and LA are randomised to surgery under GA (control group) or LA (intervention group). Those who refuse to be randomised are asked to attend the study on the basis of their own choice of anaesthesia (preference arm) and will be analysed separately. The primary endpoint is patient satisfaction according to a psychometrically validated questionnaire; secondary endpoints are complication rates, capnometry, actual costs and cost effectiveness. The study ends after inclusion of 54 patients in each of the two randomised study groups.

Discussion

The PASSAT study is the first randomised controlled trial to systematically assess patients’ satisfaction depending on LA or GA. The study follows an interdisciplinary approach, and its results may also be applicable to other surgical disciplines. It is also the first cost study based on randomised samples. Comparison of the randomised and the non-randomised groups may contribute to satisfaction research.

Trial registration

German Clinical Trials Register, DRKS00013661. Registered on 23 March 2018.
Appendix
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Literature
1.
Katlic MR. Video-assisted thoracic surgery utilizing local anesthesia and sedation. Eur J Cardiothorac Surg. 2006; 30(3):529–32.CrossRef
2.
Loddenkemper R. Zur Geschichte und Zukunft der Thorakoskopie. Pneumol (Stuttgart, Germany). 2004; 58(1):42–9.CrossRef
3.
Della Rocca G, Coccia C. Acute lung injury in thoracic surgery. Curr Opin Anaesthesiol. 2013; 26(1):40–6.CrossRef
4.
Fanelli V, Vlachou A, Ghannadian S, Simonetti U, Slutsky AS, Zhang H. Acute respiratory distress syndrome: new definition, current and future therapeutic options. J Thorac Dis. 2013; 5(3):326–34.PubMedPubMedCentral
5.
Lohser J, Slinger P. Lung injury after one-lung ventilation: a review of the pathophysiologic mechanisms affecting the ventilated and the collapsed lung. Anesth Analg. 2015; 121(2):302–18.CrossRef
6.
Schilling T, Kozian A, Huth C, Bühling F, Kretzschmar M, Welte T, Hachenberg T. The pulmonary immune effects of mechanical ventilation in patients undergoing thoracic surgery. Anesth Analg. 2005; 101(4):957–65.CrossRef
7.
Gruber EM, Tschernko EM. Anaesthesia and postoperative analgesia in older patients with chronic obstructive pulmonary disease: special considerations. Drugs Aging. 2003; 20(5):347–60.CrossRef
8.
Whitlock EL, Torres BA, Lin N, Helsten DL, Nadelson MR, Mashour GA, Avidan MS. Postoperative delirium in a substudy of cardiothoracic surgical patients in the BAG-RECALL clinical trial. Anesth Analg. 2014; 118(4):809–17.CrossRef
9.
Tomasi R, von Dossow-Hanfstingl V. Critical care strategies to improve neurocognitive outcome in thoracic surgery. Curr Opin Anaesthesiol. 2014; 27(1):44–8.CrossRef
10.
Ozyurtkan MO, Yildizeli B, Kuşçu K, Bekiroğlu N, Bostanci K, Batirel HF, Yüksel M. Postoperative psychiatric disorders in general thoracic surgery: incidence, risk factors and outcomes. Eur J Cardiothorac Surg. 2010; 37(5):1152–7.CrossRef
11.
Weinrebe W, Johannsdottir E, Karaman M, Füsgen I. What does delirium cost? An economic evaluation of hyperactive delirium. Z Gerontol Geriatr. 2016; 49(1):52–8.CrossRef
12.
Rahman NM, Ali NJ, Brown G, Chapman SJ, Davies RJO, Downer NJ, Gleeson FV, Howes TQ, Treasure T, Singh S, Phillips GD. Local anaesthetic thoracoscopy: British Thoracic Society pleural disease guideline 2010. Thorax. 2010; 65 Suppl 2:54–60.
13.
Noda M, Okada Y, Maeda S, Sado T, Sakurada A, Hoshikawa Y, Endo C, Kondo T. Is there a benefit of awake thoracoscopic surgery in patients with secondary spontaneous pneumothorax?J Thorac Cardiovasc Surg. 2012; 143(3):613–6.CrossRef
14.
Medford ARL, Agrawal S, Free CM, Bennett JA. A local anaesthetic video-assisted thoracoscopy service: prospective performance analysis in a UK tertiary respiratory centre. Lung Cancer (Amst, Neth). 2009; 66(3):355–8.CrossRef
15.
Klijian AS, Gibbs M, Andonian NT. AVATS: Awake video assisted thoracic surgery–extended series report. J Cardiothorac Surg. 2014; 9:149.CrossRef
16.
Kao MC, Lan CH, Huang CJ. Anesthesia for awake video-assisted thoracic surgery. Acta Anaesthesiol Taiwan. 2012; 50(3):126–30.CrossRef
17.
Migliore M, Giuliano R, Aziz T, Saad RA, Sgalambro F. Four-step local anesthesia and sedation for thoracoscopic diagnosis and management of pleural diseases. Chest. 2002; 121(6):2032–5.CrossRef
18.
Ambrogi V, Sellitri F, Perroni G, Schillaci O, Mineo TC. Uniportal video-assisted thoracic surgery colorectal lung metastasectomy in non-intubated anesthesia. J Thorac Dis. 2017; 9(2):254–61.CrossRef
19.
Gonzalez-Rivas D, Bonome C, Fieira E, Aymerich H, Fernandez R, Delgado M, Mendez L, de La Torre M. Non-intubated video-assisted thoracoscopic lung resections: the future of thoracic surgery?Eur J Cardiothorac Surg. 2016; 49(3):721–31.CrossRef
20.
Ghisi D, Fanelli A, Tosi M, Nuzzi M, Fanelli G. Monitored anesthesia care. Minerva Anestesiol. 2005; 71(9):533–8.PubMed
21.
Ngan Kee WD, Hung VY, Roach VJ, Lau TK. A survey of factors influencing patients’ choice of anaesthesia for caesarean section. Aust N Z J Obstet Gynaecol. 1997; 37(3):300–3.CrossRef
22.
Camponovo C. Spinal 1% 2-chloroprocaine versus general anesthesia for ultra-short outpatient procedures: a retrospective analysis. Acta Biomed. 2014; 85(3):265–8.PubMed
23.
Chand G, Shafiq M, Khan A. The comparative study of submucosal resection of nasal septum under local and general anaesthesia. J Pak Med Assoc. 2012; 62(10):1020–2.PubMed
24.
Covarelli P, Badolato M, Tomassini GM, Poponesi V, Listorti C, Castellani E, Boselli C, Noya G. Sentinel lymph node biopsy under local anaesthesia versus general anaesthesia: reliability and cost-effectiveness analysis in 153 patients with malignant melanoma. Vivo (Athens, Greece). 2012; 26(2):315–8.
25.
Ahonkallio S, Santala M, Valtonen H, Martikainen H. Cost-minimisation analysis of endometrial thermal ablation in a day case or outpatient setting under different anaesthesia regimens. Eur J Obstet Gynecol Reprod Biol. 2012; 162(1):102–4.CrossRef
26.
Dhankhar DS, Sharma N, Mishra T, Kaur N, Singh S, Gupta S. Totally extraperitoneal repair under general anesthesia versus Lichtenstein repair under local anesthesia for unilateral inguinal hernia: a prospective randomized controlled trial. Surg Endosc. 2014; 28(3):996–1002.CrossRef
27.
Capuzzo M, Alvisi R. Is it possible to measure and improve patient satisfaction with anesthesia?Anesthesiol Clin. 2008; 26(4):613–26.CrossRef
28.
Chanthong P, Abrishami A, Wong J, Herrera F, Chung F. Systematic review of questionnaires measuring patient satisfaction in ambulatory anesthesia. Anesthesiology. 2009; 110(5):1061–7.CrossRef
29.
Barnett SF, Alagar RK, Grocott MPW, Giannaris S, Dick JR, Moonesinghe SR. Patient-satisfaction measures in anesthesia: qualitative systematic review. Anesthesiology. 2013; 119(2):452–78.CrossRef
30.
Hüppe M, Beckhoff M, Klotz KF, Heinzinger M, Prüssmann M, Gerlach K, Ocker H, Schmucker P. Reliabilität und Validität des Anästhesiologischen Nachbefragungsbogens bei elektiv operierten Patienten. Der Anaesthesist. 2003; 52(4):311–20.CrossRef
31.
32.
Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983; 67(6):361–70.CrossRef
33.
Ruscheweyh R, Marziniak M, Stumpenhorst F, Reinholz J, Knecht S. Pain sensitivity can be assessed by self-rating: development and validation of the Pain Sensitivity Questionnaire. Pain. 2009; 146(1-2):65–74.CrossRef
34.
Coluzzi F, Bragazzi L, Di Bussolo E, Pizza G, Mattia C. Determinants of patient satisfaction in postoperative pain management following hand ambulatory day-surgery. Minerva Med. 2011; 102(3):177–86.PubMed
35.
Attigah N, Kutter J, Demirel S, Hakimi M, Hinz U, Motsch J, Böckler D. Assessment of patients’ satisfaction in carotid surgery under local anaesthesia by psychometrical testing–a prospective cohort study. Eur J Vasc Endovasc Surg. 2011; 41(1):76–82.CrossRef
36.
Capuzzo M, Gilli G, Paparella L, Gritti G, Gambi D, Bianconi M, Giunta F, Buccoliero C, Alvisi R. Factors predictive of patient satisfaction with anesthesia. Anesth Analg. 2007; 105(2):435–42.CrossRef
37.
Lütz A, Radtke FM, Franck M, Seeling M, Gaudreau JD, Kleinwächter R, Kork F, Zieb A, Heymann A, Spies CD. Die Nursing Delirium Screening Scale (Nu-DESC) - richtlinienkonforme Ubersetzung für den Deutschsprachigen Raum. Anasthesiol Intensivmed Notfallmed Schmerzther. 2008; 43(2):98–102.CrossRef
38.
Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990; 113(12):941–8.CrossRef
39.
Baron R, Binder A, Biniek R, Braune S, Buerkle H, Dall P, Demirakca S, Eckardt R, Eggers V, Eichler I, Fietze I, Freys S, Fründ A, Garten L, Gohrbandt B, Harth I, Hartl W, Heppner HJ, Horter J, Huth R, Janssens U, Jungk C, Kaeuper KM, Kessler P, Kleinschmidt S, Kochanek M, Kumpf M, Meiser A, Mueller A, Orth M, Putensen C, Roth B, Schaefer M, Schaefers R, Schellongowski P, Schindler M, Schmitt R, Scholz J, Schroeder S, Schwarzmann G, Spies C, Stingele R, Tonner P, Trieschmann U, Tryba M, Wappler F, Waydhas C, Weiss B, Weisshaar G. Evidence and consensus based guideline for the management of delirium, analgesia, and sedation in intensive care medicine. revision 2015 (Das-Guideline 2015) - short version. Ger Med Sci. 2015; 13:19.
40.
41.
Bhattacharya S. Local anaesthesia - not a minor anaesthesia. Indian J Plast Surg. 2011; 44(3):375–6.CrossRef
42.
Koishi K, Miyazaki N, Oe Y, Asari H. Hypercapnea during thoracoscopic surgery under regional anesthesia. Masui Jpn J Anesthesiol. 1997; 46(7):966–9.
43.
Chhajed PN, Kaegi B, Rajasekaran R, Tamm M. Detection of hypoventilation during thoracoscopy: combined cutaneous carbon dioxide tension and oximetry monitoring with a new digital sensor. Chest. 2005; 127(2):585–8.CrossRef
44.
Ozgün H, Kurt MN, Kurt I, Cevikel MH. Comparison of local, spinal, and general anaesthesia for inguinal herniorrhaphy. Eur J Surg. 2002; 168(8-9):455–9.PubMed
45.
Müllender A, Melichar G, Schmucker P, Hüppe M. Psychologische Persönlichkeitsmerkmale, Operationsverlauf und Genesung bei Patienten mit Präferenz für Allgemein- oder Lokalanästhesie. Der Anaesthesist. 2006; 55(3):247–54.CrossRef
46.
Metadata
Title
Rationale and design of PASSAT — patients’ satisfaction with local or general anaesthesia in video-assisted thoracoscopic surgery: study protocol for a randomised controlled trial with a non-randomised side arm
Authors
Thomas Galetin
Pascal Bretzke
Alberto Lopez-Pastorini
Mark Schieren
Aris Koryllos
Nils Kosse
Jost Schnell
Jerome M. Defosse
Frank Wappler
Erich Stoelben
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3190-1

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