Parasternal Block for Cardiac Surgery

Not Applicable

Completed

• Conditions: Acute Pain; Postoperative Pain; Cardiac Disease; Analgesia
• Interventions: Procedure: Infiltration with local anesthetic of access to thoracic drainage; Procedure: Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage

• Registration Number: NCT04319588
• Lead Sponsor: Campus Bio-Medico University

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:

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 Timeline

• Study Start: 2020-03-06
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-21
• Study First Posted: 2020-03-24
• Primary Completion: 2020-05-09
• Study Completion: 2020-05-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case control group	Infiltration with local anesthetic of access to thoracic drainage	The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.
Parasternal Group	Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage	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.

Primary Outcome Measures

Name	Time	Method
Maximum Pain Score	24 hours	Postoperative pain assessment using the NRS scale (score from 0 to 10)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Campus Biomedico University; 🇮🇹 Rome, Roma, Italy