Loco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903551
• Other study ID #: UTurin
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2013
• Last updated: October 24, 2016
• Start date: May 2013
• Est. completion date: April 2016

Study information

• Verified date: October 2016
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Device:
• Loco-regional catheter
it is an intra-fascial catheter for realing of the drug locally

Locations

Country	Name	City	State
Italy	Cardiac Intensive Care Unit	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU lenght of stay and hospital stay		28 days	No
Secondary	Mechanical ventilation in the post-operative period		72 hours	No