The management of post-operative pain nia patients undergoing cardiac surgery mini - invasive minithoracotomy

The management of post-operative pain nia patients undergoing cardiac surgery mini - invasive minithoracotomy : Randomized trial - post-operative pain nia patients undergoing cardiac surgery mini - invasive minithoracotomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001033-24-IT

Enrollment

Registered

2021-06-08

Start date

2016-01-25

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The management of postoperative pain in patients undergoing cardiac surgery minimally invasive minithoracotomy : randomized MedDRA version: 20.0 Level: PT Classification code 10043491 Term: Thoracotomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Patients undergoing cardiac surgery minimally invasive minithoracotomy . Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Patients allergic to analgesics or anesthetics 2. Patients who have not given their consent to participate in the study 3. Patients with psychiatric disorders because it would prevent the feedback postoperative 4. Patients operated under emergency 5. Patients on ECMO ( extracorporeal circulation )

Design outcomes

Primary

Measure	Time frame
Main Objective: Assess whether the use of the technique of locoregional analgesia with catheter reduces the consumption of opioid analgesics expressed as equivalent dose for pain control for patients operated with approach of minimally invasive surgery in minithoracotomy , compared to those treated with standard analgesia ( administration intravenous ) .;Secondary Objective: 1. Reduce the time of mechanical ventilation 2. Reduction of ICU stay 3. Shorter hospital stay;Primary end point(s): -Entro le 24 ore -Entro le 48 ore -Entro le 72 ore ;Timepoint(s) of evaluation of this end point: - Within 24 hours - Within 48 hours - Within 72 hours	—

Measure

Time frame

Main Objective: Assess whether the use of the technique of locoregional analgesia with catheter reduces the consumption of opioid analgesics expressed as equivalent dose for pain control for patients operated with approach of minimally invasive surgery in minithoracotomy , compared to those treated with standard analgesia ( administration intravenous ) .;Secondary Objective: 1. Reduce the time of mechanical ventilation 2. Reduction of ICU stay 3. Shorter hospital stay;Primary end point(s): -Entro le 24 ore -Entro le 48 ore -Entro le 72 ore ;Timepoint(s) of evaluation of this end point: - Within 24 hours - Within 48 hours - Within 72 hours

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Reduce the time of mechanical ventilation 2. Reduction of ICU stay 3. Shorter hospital stay;Timepoint(s) of evaluation of this end point: within 48 hours	—

Countries

Italy

Contacts

Public ContactANESTESIA E RIANIMAZIONE 1

AOU CITTA' DELLA SALUTE E DELLA SCIENZA

dpasero@cittadellasalute.to.it0116336129

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026