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

October 24, 2016 updated by: Daniela Pasero, University of Turin, Italy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • Cardiac Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ICU lenght of stay and hospital stay
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mechanical ventilation in the post-operative period
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

July 13, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimate)

July 19, 2013

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTurin

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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