Ropivacaine Plasma Concentrations After Fascial Blocks in Elective Cardio-thoracic and Abdominal Surgery

NCT05592691 | Unknown FDA Drug

• 1 other identifier: PRAST
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Local Anesthetic Toxicity; Regional Anesthesia Morbidity; Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (23)

• 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

Study Arms (1)

Study Cohort

Patients undergoing fascial blocks in elective cardio-thoracic and abdominal surgery.

Procedure: Fascial block

Interventions

Fascial block PROCEDURE

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.

Study Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients undergoing elective cardio-thoracic and abdominal surgery with indications for the execution of fascial block
• Signature of the informed consent form.

You may not qualify if:

• Lack of informed consent form.
• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

AOU Città della Salute e della Scienza di Torino

Turin, 10100, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 29707356 BACKGROUND

• 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.

  PMID: 33426660 BACKGROUND

• 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.

  PMID: 32062870 BACKGROUND

• 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.

  PMID: 30052229 BACKGROUND

• 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.

  PMID: 25317633 BACKGROUND

• 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.

  PMID: 18788503 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Edoardo Ceraolo, MD

  A.O.U. Città della Salute e della Scienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Brazzi, Professor

CONTACT

(+39) 011 633 5505; luca.brazzi@unito.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Director

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 25, 2022
• Study Start: April 29, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-10

Locations

IT (1)