Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS)
NCT ID: NCT06289790
Last Updated: 2026-01-21
Study Results
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Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2024-04-11
2025-10-10
Brief Summary
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Detailed Description
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Randomization: An online tool (Sealed EnvelopeTM\[12\]) will be used to randomly and evenly assign patients to one of the two groups. Blocks of 4,6,8 will be used and since the blocks assignment will be random as well, the total number of patients can be slightly larger than 60. On the day of the procedure an envelope containing one block of numbers will be opened and numbers from that envelope will be drawn for consecutive patients until the block is finished.
Intervention:
under general anaesthesia, preoperative ultrasound(USG) guided ESP blockade at Th5, single shot of 30 ml 0,3 % bupivacaine (not exceeding the maximum dose of 2 mg/kg of bupivacaine) with adrenaline 5 µg/ml and dexamethasone 0,15 mg/kg intravenously, post-operative infusion of 0,9% NaCl for 6 hours, infusion rate set as if it were lignocaine 1,5 mg/kg/h vs pre-induction lignocaine bolus of 1,5 mg/kg i.v. and dexamethasone 0,15 mg/kg intravenously, intraoperative infusion of lignocaine 2 mg/kg i.v., post-operative infusion of lignocaine 1,5 mg/kg i.v. for 6 hours
Patient and nursing staff will be blinded to the performed intervention.
Primary end- points: 1) pain score (static and dynamic defined as cough effort) on numerical rating score (NRS) 1,3,6,12 hours after surgery (and on discharge from post- anaesthesia care unit \[PACU\]/after 24 hours- whichever comes sooner) 2) cumulative opioid dose after 12 hours (and on discharge from PACU/after 24 hours- whichever comes sooner)
Secondary end- points: 1) incidence of adverse effects such as: severe hypotension (defined as a 20% drop of either mean arterial pressure (MAP), systolic blood pressure (SBP) or diastolic blood pressure (DBP) compared to baseline measured in the ward prior to surgery)\[BP measured at 1,3,6,12 hour and on discharge from PACU or more frequently if needed), nausea and vomiting, priuritis, local anaesthetic systemic toxicity symptoms.
2\) intra- operative cumulative opioid dose 3) time to discharge from hospital (max. observation time: 30 days)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ESP block group
under general anaesthesia, preoperative ultrasound(USG) guided ESP blockade at Th5, single shot of 30 ml 0,3 % bupivacaine (not exceeding the maximum dose of 2 mg/kg of bupivacaine) with adrenaline 5 µg/ml and dexamethasone 0,15 mg/kg intravenously, post-operative infusion of 0,9% NaCl for 6 hours, infusion rate set as if it were lignocaine 1,5 mg/kg/h
Erector Spinae Plane (ESP) block
Erector Spinae Plane (ESP) block with bupivacaine and for pain management in VATS procedure
Bupivacaine
Bupivicaine with adrenaline will be used to perform the ESP block
Lignocaine infusion group
pre-induction lignocaine bolus of 1,5 mg/kg i.v. and dexamethasone 0,15 mg/kg intravenously, intraoperative infusion of lignocaine 2 mg/kg i.v., post-operative infusion of lignocaine 1,5 mg/kg i.v. for 6 hours
Lignocaine
Lignocaine bolus and infusion for pain management in VATS procedure
Interventions
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Erector Spinae Plane (ESP) block
Erector Spinae Plane (ESP) block with bupivacaine and for pain management in VATS procedure
Lignocaine
Lignocaine bolus and infusion for pain management in VATS procedure
Bupivacaine
Bupivicaine with adrenaline will be used to perform the ESP block
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* VATS for tumor resection or partial lung resection in emphysema
* Written, informed consent obtained 1 day prior to surgery
Exclusion Criteria
* History of allergy to local anaesthetics
* Other contraindications to ESP blockade
* American Society of Anesthesiologists(ASA) Physical Status Classification value 4 or higher
* VATS for indications other than tumor resection or partial lung resection in emphysema
* Insulin- dependent diabetes mellitus
* More than 1 chest drain post-operatively
* Conversion to thoracotomy
* Chronic opioid use prior to surgery defined as opioid administration for at least 3 months during the last 12 months
* History of alcohol abuse
* Suspected technical difficulties with performing the ESP block (e.g. obesity)
* Inadequate spread of the local anaesthetic during the ESP block
* Cognitive impairment that might cause an inaccurate assessment of pain levels
18 Years
ALL
No
Sponsors
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Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
OTHER
Responsible Party
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Antoni Okniński
Principal Investigator
Principal Investigators
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Antoni Okniński, MD
Role: PRINCIPAL_INVESTIGATOR
National Medical Institute of the Ministry of the Interior and Administration
Locations
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National Medical Institute of the Ministry of the Interior and Administration
Warsaw, Masovian Voivodeship, Poland
Countries
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References
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Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4.
Misiolek H, Zajaczkowska R, Daszkiewicz A, Woron J, Dobrogowski J, Wordliczek J, Owczuk R. Postoperative pain management - 2018 consensus statement of the Section of Regional Anaesthesia and Pain Therapy of the Polish Society of Anaesthesiology and Intensive Therapy, the Polish Society of Regional Anaesthesia and Pain Therapy, the Polish Association for the Study of Pain and the National Consultant in Anaesthesiology and Intensive Therapy. Anaesthesiol Intensive Ther. 2018;50(3):173-199. doi: 10.5603/AIT.2018.0026.
Hou YH, Shi WC, Cai S, Liu H, Zheng Z, Qi FW, Li C, Feng XM, Peng K, Ji FH. Effect of Intravenous Lidocaine on Serum Interleukin-17 After Video-Assisted Thoracic Surgery for Non-Small-Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial. Drug Des Devel Ther. 2021 Aug 3;15:3379-3390. doi: 10.2147/DDDT.S316804. eCollection 2021.
Liu ZJ, Zhang LY, Zheng XG, Shen L, Song KC, Yi J, Huang YG. [Effects of Continuous Intravenous Intraoperative Lidocaine Infusion on Opioids Consumption and Postoperative Recovery in Patients Undergoing Video-assisted Thoracoscopic Lobectomy]. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2018 Apr 28;40(2):163-169. doi: 10.3881/j.issn.1000-503X.2018.02.005. Chinese.
Wang L, Sun J, Zhang X, Wang G. The Effect of Lidocaine on Postoperative Quality of Recovery and Lung Protection of Patients Undergoing Thoracoscopic Radical Resection of Lung Cancer. Drug Des Devel Ther. 2021 Apr 7;15:1485-1493. doi: 10.2147/DDDT.S297642. eCollection 2021.
Umari M, Falini S, Segat M, Zuliani M, Crisman M, Comuzzi L, Pagos F, Lovadina S, Lucangelo U. Anesthesia and fast-track in video-assisted thoracic surgery (VATS): from evidence to practice. J Thorac Dis. 2018 Mar;10(Suppl 4):S542-S554. doi: 10.21037/jtd.2017.12.83.
Yao Y, Jiang J, Lin W, Yu Y, Guo Y, Zheng X. Efficacy of systemic lidocaine on postoperative quality of recovery and analgesia after video-assisted thoracic surgery: A randomized controlled trial. J Clin Anesth. 2021 Aug;71:110223. doi: 10.1016/j.jclinane.2021.110223. Epub 2021 Mar 3.
Slovack M, Taylor B, Bryce R, Ong D. Does intravenous lidocaine infusion during video-assisted thoracoscopic surgery reduce postoperative analgesia? A randomized controlled study. Can J Anaesth. 2015 Jun;62(6):676-7. doi: 10.1007/s12630-015-0333-z. Epub 2015 Feb 11. No abstract available.
Gola W, Zając M, Cugowski A. Adiuwanty w blokadach nerwów obwodowych - aktualny stan wiedzy. Anestezjologia Intensywna Terapia. 2020:325-332.
Cohen, Edmond. Cohen's Comprehensive Thoracic Anesthesia. Available from: Elsevier eBooks+, Elsevier - OHCE, 2021
Sealed Envelope Ltd. 2022. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists
Other Identifiers
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16/BW/2023'
Identifier Type: -
Identifier Source: org_study_id
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