Ropivacaine Plasma Concentrations After Fascial Blocks in Elective Cardio-thoracic and Abdominal Surgery
NCT ID: NCT05592691
Last Updated: 2022-11-03
Study Results
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Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2022-04-29
2024-04-30
Brief Summary
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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.
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Detailed Description
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The advent of ultrasound-guided LRA procedures has led to the development of numerous fascial blocks, which involve the injection, at the level of the muscle-fascial planes, of an abundant volume of low-concentration local anesthetic to allow spread to adjacent nerve structures. The fascial blocks represent a valid alternative to epidural analgesia for the control of postoperative pain in the thoracoabdominal area, as they are characterized by a rapid learning curve and a lower risk of periprocedural complications compared to neuraxial anesthesia procedures.
The main chest wall nerve blocks used in clinical practice include the pectoral nerve block (PECS1 and PECS2) and serrate anterior plane block (SAP) at the level of the anterior chest wall; the spinal erector plane (ESP) block and the paravertebral block at the level of the posterior thoracic wall.
LRA techniques also play a fundamental role in the field of abdominal surgery, especially in the context of multimodal analgesia, aiming to reduce consumption and, consequently, the secondary side effects of the use of opioids.
In the case of laparotomic major abdominal surgery, the use of epidural analgesia has been shown to be effective in reducing post-operative pain, opioid consumption, and recovery of gastrointestinal function, but has not shown a significant reduction in the duration of hospitalization and of post-operative complications.
Subarachnoid analgesia is mainly indicated in laparoscopic abdominal surgery. Numerous studies have shown an efficacy similar to epidural anesthesia in controlling pain and reducing opioid consumption as well as allowing early patient mobilization and a shorter length of hospital stay.
The transverse abdominal plane (TAP) block has a rapid learning curve and has been shown to be effective in controlling postoperative analgesia, reducing opioids consumption and reducing hospital stay.
The lumbar square (QoL) block has a greater efficacy than other abdominal wall blocks on the visceral component of pain. A recent meta-analysis demonstrated greater efficacy than TAP in the control of post-operative pain and guarantees a longer duration of analgesia.
The effectiveness of the anesthetic depends on its local action at the level of the nervous structures "wetted" by the drug; a variable amount of local anesthetic undergoes systemic absorption and might be responsible for part of the analgesic effect, but above all for the possible appearance of systemic side effects.10 The amount of drug redistributing in the blood depends on the total dose of the drug administered, the route of administration, and the vascularity of the injection site.
Ropivacaine is a long-acting amide local anesthetic frequently used in LRA procedures. Unlike other drugs of the same family, the levorotatory enantiomer S-Ropivacaine is characterized by reduced lipophilicity and this determines a lower risk of toxicity to the Central Nervous System (CNS) and cardiovascular system (CVS). The drug exhibits high plasma protein binding (α1-acid glycoprotein), linear absorption kinetics, hepatic metabolism, and renal elimination.
Systemic toxicity from Local anesthetic (LAST) represents a complication of local anesthetic administration and is directly dependent on the plasma concentration of the drug. The signs and symptoms of LAST occur progressively and mainly affect the CNS (visual disturbances, perioral hypoaesthesia, dizziness, euphoria, muscle stiffness, spasms, convulsions) and the CVS system (hypotension, bradycardia, arrhythmias, cardiac arrest).
The study aims to observe the onset of local anesthetic toxicity (LAST) after performing fascial blocks in patients undergoing elective cardiothoracic and abdominal surgery.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study Cohort
Patients undergoing fascial blocks in elective cardio-thoracic and abdominal surgery.
Fascial block
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.
Interventions
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Fascial block
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.
Eligibility Criteria
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Inclusion Criteria
* Signature of the informed consent form.
Exclusion Criteria
* Previous neuropsychiatric pathologies or neuropathies of the back / trunk
* Severe renal insufficiency (GFR \<30ml / min)
* Severe hepatic insufficiency or alteration of liver enzymes
* Contraindications to LRA procedures (injection site infection, coagulopathy, allergy / hypersensitivity to local anesthetics)
* Pregnancy
* Hypoalbuminemia
* Hospitalization in intensive care and / or post-operative sedation\> 24 hours
18 Years
ALL
No
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Luca Brazzi
Full Professor, Director
Principal Investigators
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Edoardo Ceraolo, MD
Role: PRINCIPAL_INVESTIGATOR
A.O.U. Città della Salute e della Scienza
Locations
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AOU Città della Salute e della Scienza di Torino
Turin, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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PRAST
Identifier Type: -
Identifier Source: org_study_id
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