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

University of Turin

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Device: Loco-regional catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01903551

UTurin

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Loco-regional catheter

Experimental group

Description:

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).

Treatment:

Device: Loco-regional catheter

Intravenous analgesia

No Intervention group

Description:

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