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

NCT ID: NCT01903551

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-04-30

Brief Summary

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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

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Conditions

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Pain, Postoperative

Keywords

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post-operative pain loco-regional analgesia minimally invasive surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Loco-regional catheter

Intervention Type DEVICE

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

Intravenous analgesia

At the end of the cardiac intervention each patient will receive intravenous analgesia with morphine at 0.8 mg/h.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Loco-regional catheter

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Daniela Pasero

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cardiac Intensive Care Unit

Turin, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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UTurin

Identifier Type: -

Identifier Source: org_study_id