NCT01903551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

2.1 years

First QC Date

July 13, 2013

Last Update Submit

October 24, 2016

Conditions

Pain, Postoperative

Keywords

post-operative painloco-regional analgesiaminimally invasive surgery

Outcome Measures

Primary Outcomes (1)

  • ICU lenght of stay and hospital stay

    28 days

Secondary Outcomes (1)

  • Mechanical ventilation in the post-operative period

    72 hours

Study Arms (2)

Loco-regional catheter

EXPERIMENTAL

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

Intravenous analgesia

NO INTERVENTION

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

Interventions

Loco-regional catheterDEVICE

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

Loco-regional catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing minithoracotomy for cardiac surgery, \> 18 years old

You may not qualify if:

  • psychiatric diseases, which might limit pain evaluation; urgent surgery; patients on ECMO; lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiac Intensive Care Unit

Turin, Italy, 10126, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 13, 2013

First Posted

July 19, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2015

Study Completion

April 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

IT(1)