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Completed

NCT Number: NCT01903551

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cardiac Intensive Care Unit

Turin, Italy, 10126

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loco-regional catheter

Device

it is an intra-fascial catheter for realing of the drug locally

Primary outcomes

  1. ICU lenght of stay and hospital stay

    Time frame: 28 days

Secondary outcomes

  1. Mechanical ventilation in the post-operative period

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 19, 2013
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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