Parasternal Block for Cardiac Surgery (Parasternal)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Analgesia; Acute Pain; Cardiac Disease
• Intervention / Treatment: Procedure: Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage; Procedure: Infiltration with local anesthetic of access to thoracic drainage

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 Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giulia Nonnis; Phone Number: 3382752818; Email: g.nonnis@unicampus.it

Study Locations

• Italy
  • Roma
    • Rome, Roma, Italy, 00128
      • Campus Biomedico University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Parasternal 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.	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.
ACTIVE_COMPARATOR: Case control group; 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; Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.

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
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
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

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Publications and helpful links

General Publications

• 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, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2020
• Primary Completion (ACTUAL): May 9, 2020
• Study Completion (ACTUAL): May 19, 2020

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 21, 2020
• First Posted (ACTUAL): March 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pain; Neurologic Manifestations; Heart Diseases; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 20/20 PAR ComEt CBM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No