Back to resultsLoco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Loco-regional catheter
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring post-operative pain, loco-regional analgesia, minimally invasive surgery
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
Sites / Locations
- Cardiac Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Loco-regional catheter
Intravenous analgesia
Arm Description
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).
At the end of the cardiac intervention each patient will receive intravenous analgesia with morphine at 0.8 mg/h.
Outcomes
Primary Outcome Measures
ICU lenght of stay and hospital stay
Secondary Outcome Measures
Mechanical ventilation in the post-operative period
Full Information
NCT ID
NCT01903551
First Posted
July 13, 2013
Last Updated
October 24, 2016
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT01903551
Brief Title
Loco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery
Official Title
Phase 3 Study of Post-operative Pain Management With Loco-regional Analgesia in Minithoracotomy for Cardiac Surgery. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
post-operative pain, loco-regional analgesia, minimally invasive surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Loco-regional catheter
Arm Type
Experimental
Arm Description
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).
Arm Title
Intravenous analgesia
Arm Type
No Intervention
Arm Description
At the end of the cardiac intervention each patient will receive intravenous analgesia with morphine at 0.8 mg/h.
Intervention Type
Device
Intervention Name(s)
Loco-regional catheter
Intervention Description
it is an intra-fascial catheter for realing of the drug locally
Primary Outcome Measure Information:
Title
ICU lenght of stay and hospital stay
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Mechanical ventilation in the post-operative period
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cardiac Intensive Care Unit
City
Turin
ZIP/Postal Code
10126
Country
Italy
12. IPD Sharing Statement
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Loco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery
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