Parasternal Block for Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups: Interventional (parasternal group) 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.

Official Title
-----------------
Parasternal Block for Postoperative Analgesia in Cardiac Surgery: a Pilot Controlled Trial

Conditions
-----------------
Cardiac Disease, Analgesia, Acute Pain, Postoperative Pain

Intervention / Treatment
-----------------
* Procedure: Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage
* Procedure: Infiltration with local anesthetic of access to thoracic drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parasternal Group<br>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. | Procedure: Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage<br>* After induction of general anesthesia we will perform an ultrasound-guided Parasternal Block in association with infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.<br>|
| Active Comparator: Case control group<br>The case control group will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids. | Procedure: Infiltration with local anesthetic of access to thoracic drainage<br>* Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Pain Score | Postoperative pain assessment using the NRS scale (score from 0 to 10) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory performance at the TRI-FLOW | Respiratory performance is assessed by the number of balls raised during inspiration with the TRI-FLOW | 24 hours | 
| Intraoperative opioid administration | Quantitative evaluation of opioids needed in the intraoperative period | 4 hours | 
| Total opioids consumption | Number of opioid deliveries (bolus morphine) in the postoperative period | 24 hours | 
| Time to first opioid | The time in minutes between awakening and the first opioid administration | 48 hours |