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

Phase 3

Completed

• Conditions: Pain, Postoperative
• Interventions: Device: Loco-regional catheter

• Registration Number: NCT01903551
• Lead Sponsor: University of Turin, Italy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-13
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-19
• Primary Completion: 2015-06
• Study Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loco-regional catheter	Loco-regional catheter	A suprafascial catheter will be positioned at the end of cardiac intervention during the thoracotomy closure. The catheter will be connected to a elastomeric pump, which delivers the analgesic drug (ropivacaine).

Primary Outcome Measures

Name	Time	Method
ICU lenght of stay and hospital stay	28 days

Secondary Outcome Measures

Name	Time	Method
Mechanical ventilation in the post-operative period	72 hours

Trial Locations

Locations (1)

Cardiac Intensive Care Unit; 🇮🇹 Turin, Italy