Parasternal Block for Cardiac Surgery

Campus Bio-Medico University of Rome

Status: Completed

Conditions: Postoperative Pain; Cardiac Disease; Analgesia; Acute Pain

Treatments: Procedure: Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage; Procedure: Infiltration with local anesthetic of access to thoracic drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT04319588

20/20 PAR ComEt CBM

Details and patient eligibility

About

This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Half of participants will receive General Anesthesia combined to parasternal block while the other half receive only General Anesthesia.

Full description

60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups:

1. Interventional (parasternal group)
2. Case control group The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.

The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing elective cardiac surgery
• Age over 18 years
• ASA I-IV
• Approval by the patient of informed consent

Exclusion criteria

• Allergy to local anesthetics
• Puncture site infection
• Lack of signing of informed consent
• Weight <30 Kg
• Age <18 years
• Emergency interventions
• ASA > IV
• Sternal dehiscences
• Dementia (for difficulties in managing weaning from mechanical ventilation and pain)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Parasternal Group

Experimental group

Description:

The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.

Treatment:

Procedure: Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage

Case control group

Active Comparator group

Description:

The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.

Treatment:

Procedure: Infiltration with local anesthetic of access to thoracic drainage