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Clinical Trials/NCT01903551
NCT01903551
Completed
Phase 3

Phase 3 Study of Post-operative Pain Management With Loco-regional Analgesia in Minithoracotomy for Cardiac Surgery. A Randomized Controlled Trial

University of Turin, Italy1 site in 1 country56 target enrollmentMay 2013

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Pain, Postoperative
Sponsor
University of Turin, Italy
Enrollment
56
Locations
1
Primary Endpoint
ICU lenght of stay and hospital stay
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The aim of the study is to evaluate whether loco-regional analgesia reduces post operative pain compared to intravenous analgesia, in patients undergoing cardiac surgery in minithoracotomy. All patients will be randomized to receive locoregional analgesia (treatment group) or intravenous analgesia (control group), at the end of the cardiac intervention.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
April 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Turin, Italy
Responsible Party
Principal Investigator
Principal Investigator

Daniela Pasero

Medical Doctor

University of Turin, Italy

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing minithoracotomy for cardiac surgery, \> 18 years old

Exclusion Criteria

  • psychiatric diseases, which might limit pain evaluation; urgent surgery; patients on ECMO; lack of consent

Outcomes

Primary Outcomes

ICU lenght of stay and hospital stay

Time Frame: 28 days

Secondary Outcomes

  • Mechanical ventilation in the post-operative period(72 hours)

Study Sites (1)

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