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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01903551

Enrollment

Registered

2013-07-19

Start date

2013-05-31

Completion date

2016-04-30

Last updated

2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

post-operative pain, loco-regional analgesia, minimally invasive surgery

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.

Interventions

DEVICELoco-regional catheter

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
ICU lenght of stay and hospital stay	28 days

Secondary

Measure	Time frame
Mechanical ventilation in the post-operative period	72 hours

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026