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

Phase 1

• Conditions: The management of postoperative pain in patients undergoing cardiac surgery minimally invasive minithoracotomy : randomized; MedDRA version: 20.0Level: PTClassification code 10043491Term: ThoracotomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-001033-24-IT
• Lead Sponsor: AOU CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-08
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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

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 )

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>2. Reduction of ICU stay<br>3. Shorter hospital stay;Primary end point(s): -Entro le 24 ore<br>-Entro le 48 ore<br>-Entro le 72 ore<br>;Timepoint(s) of evaluation of this end point: - Within 24 hours<br>- Within 48 hours<br>- Within 72 hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Reduce the time of mechanical ventilation<br>2. Reduction of ICU stay<br>3. Shorter hospital stay;Timepoint(s) of evaluation of this end point: within 48 hours