Parasternal Block for Cardiac Surgery

Postoperative Pain Clinical Trial

— Parasternal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319588
• Other study ID #: 20/20 PAR ComEt CBM
• Status: Completed
• Phase: N/A
• Start date: March 6, 2020
• Est. completion date: May 19, 2020

Study information

• Verified date: February 2023
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: May 19, 2020
• Est. primary completion date: May 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Cardiac Disease
• Heart Diseases
• Postoperative Pain

Intervention

Procedure:
• Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage
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 drainage
Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.

Locations

Country	Name	City	State
Italy	Campus Biomedico University	Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, W — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Pain Score	Postoperative pain assessment using the NRS scale (score from 0 to 10)	24 hours
Secondary	Respiratory performance at the TRI-FLOW	Respiratory performance is assessed by the number of balls raised during inspiration with the TRI-FLOW	24 hours
Secondary	Intraoperative opioid administration	Quantitative evaluation of opioids needed in the intraoperative period	4 hours
Secondary	Total opioids consumption	Number of opioid deliveries (bolus morphine) in the postoperative period	24 hours
Secondary	Time to first opioid	The time in minutes between awakening and the first opioid administration	48 hours