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

Thoracic Surgery, Video-Assisted Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06289790
• Other study ID #: 16/BW/2023'
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: November 7, 2024

Study information

• Verified date: February 2024
• Source: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
• Contact: Antoni Okninski, MD
• Phone: 608310346
• Email: antoniokninski[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 7, 2024
• Est. primary completion date: November 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Surgery, Video-Assisted

Intervention

Procedure:
• Erector Spinae Plane (ESP) block
Erector Spinae Plane (ESP) block for pain management in VATS procedure

Drug:
• Lignocaine
Lignocaine bolus and infusion for pain management in VATS procedure

Locations

Country	Name	City	State
Poland	National Medical Institute of the Ministry of the Interior and Administration	Warsaw	Mazowieckie

Sponsors (1)

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

Country where clinical trial is conducted

Poland, 

References & Publications (12)

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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	BP measured at 1,3,6,12 hour and on discharge from PACU or more frequently if needed
Secondary	incidence of nausea and vomiting	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
Secondary	incidence of priuritis	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
Secondary	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.	anytime during post-surgery period until discharge from PACU/after 24 hours- whichever comes sooner
Secondary	intra-operative cumulative opioid dose	measured as fentanyl equivalent	intra-operative
Secondary	time to discharge from hospital	measured as number of days in the hospital counting from the day of the surgery	max. observation time: 30 days