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

NCT05592691 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2022-11-03

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Edoardo Ceraolo, MD · A.O.U. Città della Salute e della Scienza

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-29
Primary Completion
2024-04-30
Completion
2024-04-30
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05592691 on ClinicalTrials.gov