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

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ClinicalTrials.gov Identifier: NCT01903551
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Daniela Pasero, 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Device: Loco-regional catheter Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Post-operative Pain Management With Loco-regional Analgesia in Minithoracotomy for Cardiac Surgery. A Randomized Controlled Trial
Study Start Date : May 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).
Device: Loco-regional catheter
it is an intra-fascial catheter for realing of the drug locally

No Intervention: Intravenous analgesia
At the end of the cardiac intervention each patient will receive intravenous analgesia with morphine at 0.8 mg/h.



Primary Outcome Measures :
  1. ICU lenght of stay and hospital stay [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Mechanical ventilation in the post-operative period [ Time Frame: 72 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903551


Locations
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Italy
Cardiac Intensive Care Unit
Turin, Italy, 10126
Sponsors and Collaborators
University of Turin, Italy

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Responsible Party: Daniela Pasero, Medical Doctor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT01903551     History of Changes
Other Study ID Numbers: UTurin
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by Daniela Pasero, University of Turin, Italy:
post-operative pain
loco-regional analgesia
minimally invasive surgery

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms