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

January 19, 2026 updated by: Antoni Okniński, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

2) intra- operative cumulative opioid dose 3) time to discharge from hospital (max. observation time: 30 days)

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-507
        • National Medical Institute of the Ministry of the Interior and Administration

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

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

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Procedure: Erector Spinae Plane (ESP) block
Erector Spinae Plane (ESP) block with bupivacaine and for pain management in VATS procedure
Other Names:
  • ESP blockade
Drug: Bupivacaine
Bupivicaine with adrenaline will be used to perform the ESP block
Active Comparator: 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
Drug: Lignocaine
Lignocaine bolus and infusion for pain management in VATS procedure
Other Names:
  • Lignocaine infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
Time Frame: 12 hours after the end of the surgery (and on discharge from PACU/after 24 hours- whichever comes sooner)
measured as fentanyl equivalent
12 hours after the end of the surgery (and on discharge from PACU/after 24 hours- whichever comes sooner)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of severe hypotension
Time Frame: BP measured at 1,3,6,12 hour and on discharge from PACU or more frequently if needed
(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
incidence of nausea and vomiting
Time Frame: anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
patients will be monitored for incidence of nausea and vomiting and incidence of those will be noted
anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
incidence of priuritis
Time Frame: anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
patients will be monitored for incidence of priuritis and incidence of it will be noted
anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
incidence of local anaesthetic systemic toxicity symptoms
Time Frame: anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
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.
anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
intra-operative cumulative opioid dose
Time Frame: intra-operative
measured as fentanyl equivalent
intra-operative
time to discharge from hospital
Time Frame: max. observation time: 30 days
measured as number of days in the hospital counting from the day of the surgery
max. observation time: 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Antoni Okniński, MD, National Medical Institute of the Ministry of the Interior and Administration

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2024

Primary Completion (Actual)

October 10, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/BW/2023'

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

From the time of publication. No end date.

IPD Sharing Access Criteria

Researchers who provide a sound reason for obtaining the data. Reasearches will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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