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Search / Trial NCT06360666

Clinical Outcomes in Adult Patients Undergoing Laparoscopic Surgery Under Neuraxial Anesthesia

Launched by ASST MELEGNANO E MARTESANA · Apr 10, 2024

Trial Information

Current as of November 14, 2025

Enrolling by invitation

Keywords

Awareness Locoregional Anesthesia General Anesthesia Laparoscopic Abdominal Surgery

ClinConnect Summary

This is an observational study at a single hospital in Italy that looks back at adults undergoing elective laparoscopic major abdominal surgery to compare two ways of giving anesthesia: general anesthesia (you are unconscious) versus locoregional anesthesia (a nerve‑block approach that keeps you awake but sedated). The main questions are about safety and recovery in the first 90 days after surgery, specifically death and how long you stay in the hospital. Researchers will also check how often people needed a second operation or developed organ problems, again within 90 days, to see if one anesthesia method is linked to fewer complications.

To take part, people need to be adults (over 18) with a slightly higher health risk before surgery (ASA score greater than 1) and limited heart-litness performance (METs less than 10). Anyone with the simplest health status (ASA 1) or better fitness (METs 10 or higher), those having open or emergency surgery, or those with certain problems that make central nerve blocks unsafe (like blood clotting issues, severe spine problems, allergy to local anesthetics, severe aortic stenosis, sepsis, or infection at the puncture site) would not be eligible. The study collects information from medical records and follows up with patients by phone or visits about 1 and 3 months after surgery to check neurological status and survival. Data are kept private under privacy laws, and results will be published after the study finishes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age \>18 years
  • "ASA physical status"\>1 (ASA=American Society of Anesthesiologists)
  • METs\<10 (MET= Metabolic Equivalent)
  • Exclusion Criteria:
  • "ASA physical status"=1
  • METs≥10
  • patients undergoing laparotomy or emergency surgery, presenting contraindications to central locoregional anesthesia execution (specifically: coagulation disorders, severe spinal malformations, known allergy to local anesthetics, severe aortic stenosis, systemic sepsis, puncture site infection)

About Asst Melegnano E Martesana

Asst Melegnano e Martesana is a prominent healthcare organization based in Italy, dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to fostering collaboration among healthcare professionals, researchers, and patients, the organization focuses on a wide range of therapeutic areas, aiming to enhance treatment outcomes and contribute to the scientific community. With a strong emphasis on ethical standards and patient safety, Asst Melegnano e Martesana plays a vital role in the development of new therapies and medical practices, striving to address the evolving needs of the population it serves.

Locations

Vizzolo Predabissi, Milan, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported