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Thoracic Surgery, Video-AssistedNCT06289790

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

A study testing Erector Spinae Plane (ESP) block, Lignocaine and Bupivacaine in people with Thoracic Surgery, Video-Assisted, run by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thoracic Surgery, Video-Assisted
What is being tested?
Erector Spinae Plane (ESP) block, Lignocaine and Bupivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 sitePoland
Study dates
11 Apr 2024to 10 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • National Medical Institute of the Ministry of the Interior and Administration

    Warsaw, Masovian Voivodeship, 02-507

Other trials in Poland

About this study

Official title: Analgesic Efficacy of Erector Spinae Plane (ESP) Block vs Intravenous Lignocaine Infusion in Video- Assisted Thoracoscopy (VATS)

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

Read the detailed description

Number of patients: 60 patients enrolled for VATS procedure randomly and evenly assigned to one of the 2 groups.

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.

  1. intra- operative cumulative opioid dose 3) time to discharge from hospital (max. observation time: 30 days)
Being tested
Erector Spinae Plane (ESP) block, Lignocaine, Bupivacaine
Keywords
esp block, lignocaine, Thoracic Surgery, Video-Assisted, erector spinae block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erector Spinae Plane (ESP) blockProcedure or surgery

    Also called ESP blockade

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

  • LignocaineDrug

    Also called Lignocaine infusion

    Lignocaine bolus and infusion for pain management in VATS procedure

  • BupivacaineDrug

    Bupivicaine with adrenaline will be used to perform the ESP block

Study groups in NCT06289790
Study groupRoleWhat they receive
ESP block groupActive comparatorunder 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
Receives: Procedure: Erector Spinae Plane (ESP) block; Drug: Bupivacaine
Lignocaine infusion groupActive comparatorpre-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
Receives: Drug: Lignocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 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

    measured as fentanyl equivalent

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

Secondary outcomes (6)
  1. incidence of 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

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

  2. incidence of nausea and vomiting

    patients will be monitored for incidence of nausea and vomiting and incidence of those will be noted

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

  3. incidence of priuritis

    patients will be monitored for incidence of priuritis and incidence of it will be noted

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

  4. incidence of local anaesthetic systemic toxicity symptoms

    Patients will be monitored for the following symptoms: limbs numbness, tinnitus, seizures, coma, bradycardia (defined as heart rate below 45 beats per minute), severe ventrical arrhytmias. Incidence of those will be noted.

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

  5. intra-operative cumulative opioid dose

    measured as fentanyl equivalent

    Measured: intra-operative

  6. time to discharge from hospital

    measured as number of days in the hospital counting from the day of the surgery

    Measured: max. observation time: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start11 Apr 2024
  3. Primary completion10 Oct 2025
  4. Study completion10 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06289790
Sponsor's protocol ID
16/BW/2023'
Status last verified
Jan 2026
First submitted
19 Feb 2024
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual Participant Data that underlie the results of the publication will be available for researchers upon request and after providing a detailed rationale for obtaining those. All of the data will be deidentified so that the participants will remain anonymous. In order to obtain the data please contact the Principal Investigator at antoni.okninski@cskmswia.gov.pl.

Publications

  • 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.

    PubMed 27501016
  • 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.

    PubMed 30621377
  • 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.

    PubMed 30124229
  • 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.

    PubMed 34376972
  • 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.

    PubMed 29724305
  • 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.

    PubMed 33854301
  • 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.

    PubMed 29629201
  • 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.

    PubMed 33676296
  • 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.

    PubMed 25670347
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing Erector Spinae Plane (ESP) block, Lignocaine and Bupivacaine in people with Thoracic Surgery, Video-Assisted, run by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain score on numerical rating score (time frame: 1,3,6,12 hours after surgery (and on discharge from post- anaesthesia care unit [PACU]/after 24 hours- whichever comes sooner)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06289790, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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