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

U

University of Turin

Status and phase

Completed
Phase 3

Conditions

Pain, Postoperative

Treatments

Device: Loco-regional catheter

Study type

Interventional

Funder types

Other

Identifiers

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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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