Parasternal Block for Cardiac Surgery

N/ACompletedNCT04319588

Campus Bio-Medico University126 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

126

Conditions

Cardiac Disease Analgesia Acute Pain Postoperative Pain

Interventions

Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainagePROCEDURE

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.

Infiltration with local anesthetic of access to thoracic drainagePROCEDURE

Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Campus Biomedico University

Rome, Roma, Italy

Outcomes

Primary Outcomes

Maximum Pain Score

Postoperative pain assessment using the NRS scale (score from 0 to 10)

Time frame: 24 hours

Secondary Outcomes

Respiratory performance at the TRI-FLOW

Respiratory performance is assessed by the number of balls raised during inspiration with the TRI-FLOW

Time frame: 24 hours

Intraoperative opioid administration

Quantitative evaluation of opioids needed in the intraoperative period

Time frame: 4 hours

Total opioids consumption

Number of opioid deliveries (bolus morphine) in the postoperative period

Time frame: 24 hours

Time to first opioid

The time in minutes between awakening and the first opioid administration

Time frame: 48 hours

Data from ClinicalTrials.gov

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