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)
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
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 |
Country | Name | City | State |
---|---|---|---|
Poland | National Medical Institute of the Ministry of the Interior and Administration | Warsaw | Mazowieckie |
Lead Sponsor | Collaborator |
---|---|
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland |
Poland,
Cohen, Edmond. Cohen's Comprehensive Thoracic Anesthesia. Available from: Elsevier eBooks+, Elsevier - OHCE, 2021
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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. — View Citation
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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
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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
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 |
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