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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 13, 2013
First Posted Date  ICMJE July 19, 2013
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE May 2013
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
ICU lenght of stay and hospital stay [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
Mechanical ventilation in the post-operative period [ Time Frame: 72 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Loco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery
Official Title  ICMJE Phase 3 Study of Post-operative Pain Management With Loco-regional Analgesia in Minithoracotomy for Cardiac Surgery. A Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE Device: Loco-regional catheter
it is an intra-fascial catheter for realing of the drug locally
Study Arms  ICMJE
  • 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).
    Intervention: Device: Loco-regional catheter
  • No Intervention: Intravenous analgesia
    At the end of the cardiac intervention each patient will receive intravenous analgesia with morphine at 0.8 mg/h.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2013)
56
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01903551
Other Study ID Numbers  ICMJE UTurin
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daniela Pasero, University of Turin, Italy
Study Sponsor  ICMJE University of Turin, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Turin, Italy
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP