NCT05592691|UnknownFDA Drug
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Sponsor study identifier
observational
60
1 country
1
Study Start
April 29, 2022
Actual (reported)Primary Completion
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary aim: observe the incidence of systemic toxicity from local anesthetic (LAST) after performing fascial blocks in patients undergoing elective cardio-thoracic and abdominal surgery. Secondary aim: describe the pharmacokinetic profile of the local anesthetic (ropivacaine) and assess peri-procedural complications, post-operative pain and opiate consumption in the first 24 hours.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2022
Actual (reported)September 21, 2022
Actual (reported)October 25, 2022
Actual (reported)April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of systemic toxicity from local anesthetic signs and symptoms.
The typical presentation of LAST usually begins with prodromal symptoms and signs, such as perioral numbness, tinnitus, agitation, dysarthria, and confusion. These may be followed by more severe central nervous system (CNS) derangements such as seizures and coma.
6 hours after surgery
Incidence of systemic toxicity from local anesthetic signs and symptoms.
The typical presentation of LAST usually begins with prodromal symptoms and signs, such as perioral numbness, tinnitus, agitation, dysarthria, and confusion. These may be followed by more severe central nervous system (CNS) derangements such as seizures and coma.
12 hours after surgery
Incidence of systemic toxicity from local anesthetic signs and symptoms.
The typical presentation of LAST usually begins with prodromal symptoms and signs, such as perioral numbness, tinnitus, agitation, dysarthria, and confusion. These may be followed by more severe central nervous system (CNS) derangements such as seizures and coma.
24 hours after surgery
Ropivacaine concentration
5 minutes from the fascial block execution
Ropivacaine concentration
15 minutes from the fascial block execution
Ropivacaine concentration
30 minutes from the fascial block execution
Ropivacaine concentration
60 minutes from the fascial block execution
Ropivacaine concentration
120 minutes from the fascial block execution
Patients undergoing fascial blocks in elective cardio-thoracic and abdominal surgery.
The end of the drug infusion will be considered the time zero (T0); subsequently blood samples (4ml) will be taken at pre-established time intervals (after 5, 15, 30, 60, 120 and 180 minutes). Blood samples will be collected in test tubes and centrifuged within 1 hour of collection; subsequently they will be stored at a low temperature and transported to the reference analysis laboratory.
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The study involves the enrollment of patients who will undergo elective cardio-thoracic and / or abdominal surgery at the A.O.U. Città della Salute e della Scienza of Turin, with clinical indications for the execution of band blocks for analgesic purposes.
AOU Città della Salute e della Scienza di Torino
Turin, 10100, Italy
Crumley S, Schraag S. The role of local anaesthetic techniques in ERAS protocols for thoracic surgery. J Thorac Dis. 2018 Mar;10(3):1998-2004. doi: 10.21037/jtd.2018.02.48.
Chin KJ, Versyck B, Pawa A. Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:110-126. doi: 10.1111/anae.15276.
Jack JM, McLellan E, Versyck B, Englesakis MF, Chin KJ. The role of serratus anterior plane and pectoral nerves blocks in cardiac surgery, thoracic surgery and trauma: a qualitative systematic review. Anaesthesia. 2020 Oct;75(10):1372-1385. doi: 10.1111/anae.15000. Epub 2020 Feb 16.
Blood samples
Edoardo Ceraolo, MD
A.O.U. Città della Salute e della Scienza
First Submitted
September 21, 2022
First Posted
October 25, 2022
Study Start
April 29, 2022
Actual (reported)Primary Completion
April 30, 2024
Estimated (date passed)Randomized Trial of Erector Spinae Plane Block Using Liposomal Bupivacaine Versus Bupivacaine Hydrochloride on Quality of Recovery for Video-assisted Thoracic Surgery
Contact the study team to confirm eligibility.
Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
Hughes MJ, Ventham NT, McNally S, Harrison E, Wigmore S. Analgesia after open abdominal surgery in the setting of enhanced recovery surgery: a systematic review and meta-analysis. JAMA Surg. 2014 Dec;149(12):1224-30. doi: 10.1001/jamasurg.2014.210.
Leone S, Di Cianni S, Casati A, Fanelli G. Pharmacology, toxicology, and clinical use of new long acting local anesthetics, ropivacaine and levobupivacaine. Acta Biomed. 2008 Aug;79(2):92-105.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 3, 2022
Record last verified: 2022-10
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Source: ClinicalTrials.gov.
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