Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in (VATS)

NCT06289790 | Completed

• 1 other identifier: 16/BW/2023'
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare analgesic efficacy of erector spinae plane (ESP) block vs intravenous lignocaine infusion in video- assisted thoracoscopy (VATS. The main goals are to compare post- operative pain scores and cumulative post- operative opioid doses in both groups

Conditions

Thoracic Surgery, Video-Assisted

Keywords

esp block; lignocaine; Thoracic Surgery, Video-Assisted; erector spinae block

Outcome Measures

Primary Outcomes (2)

• pain score on numerical rating score

  static and dynamic score (defined as cough effort) on numerical rating score (values: 0-10 where the lower number means less pain and a better outcome)

  1,3,6,12 hours after surgery (and on discharge from post- anaesthesia care unit [PACU]/after 24 hours- whichever comes sooner)

• cumulative opioid dose

  measured as fentanyl equivalent

  12 hours after the end of the surgery (and on discharge from PACU/after 24 hours- whichever comes sooner)

Secondary Outcomes (6)

• incidence of severe hypotension

  BP measured at 1,3,6,12 hour and on discharge from PACU or more frequently if needed

• incidence of nausea and vomiting

  anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner

• incidence of priuritis

  anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner

• incidence of local anaesthetic systemic toxicity symptoms

  anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner

• intra-operative cumulative opioid dose

  intra-operative

Study Arms (2)

ESP block group

ACTIVE COMPARATOR

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

Procedure: Erector Spinae Plane (ESP) block; Drug: Bupivacaine

Lignocaine infusion group

ACTIVE COMPARATOR

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

Drug: Lignocaine

Interventions

Erector Spinae Plane (ESP) block PROCEDURE

Erector Spinae Plane (ESP) block with bupivacaine and for pain management in VATS procedure

Also known as: ESP blockade

ESP block group

Lignocaine DRUG

Lignocaine bolus and infusion for pain management in VATS procedure

Also known as: Lignocaine infusion

Lignocaine infusion group

Bupivacaine DRUG

Bupivicaine with adrenaline will be used to perform the ESP block

ESP block group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• VATS for tumor resection or partial lung resection in emphysema
• Written, informed consent obtained 1 day prior to surgery

You may not qualify if:

• Lack of consent for ESP blockade
• 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

Sponsors & Collaborators

• Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland: lead

Study Sites (1)

National Medical Institute of the Ministry of the Interior and Administration

Warsaw, Masovian Voivodeship, 02-507, Poland

Location

Related Publications (12)

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 30621377 BACKGROUND

• 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.

  PMID: 30124229 BACKGROUND

• 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.

  PMID: 34376972 BACKGROUND

• 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.

  PMID: 29724305 BACKGROUND

• 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.

  PMID: 33854301 BACKGROUND

• 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.

  PMID: 29629201 BACKGROUND

• 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.

  PMID: 33676296 BACKGROUND

• 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.

  PMID: 25670347 BACKGROUND

• Gola W, Zając M, Cugowski A. Adiuwanty w blokadach nerwów obwodowych - aktualny stan wiedzy. Anestezjologia Intensywna Terapia. 2020:325-332.

  BACKGROUND

• Cohen, Edmond. Cohen's Comprehensive Thoracic Anesthesia. Available from: Elsevier eBooks+, Elsevier - OHCE, 2021

  BACKGROUND

• Sealed Envelope Ltd. 2022. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists

  BACKGROUND

MeSH Terms

Interventions

Parapsychology; Dental Occlusion; Lidocaine; Bupivacaine

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Antoni Okniński, MD

  National Medical Institute of the Ministry of the Interior and Administration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patient and nursing staff will be blinded to the performed intervention. PI and performing anaesthesiologist will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 4, 2024
• Study Start: April 11, 2024
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From the time of publication. No end date.
• Access Criteria: Researchers who provide a sound reason for obtaining the data. Reasearches will need to sign a data access agreement.

Locations

PL (1)