Skip to main content
Clinical Trials/NCT04319588
NCT04319588
Completed
Not Applicable

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

Campus Bio-Medico University1 site in 1 country126 target enrollmentMarch 6, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Disease
Sponsor
Campus Bio-Medico University
Enrollment
126
Locations
1
Primary Endpoint
Maximum Pain Score
Status
Completed
Last Updated
3 years ago

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: 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.

Registry
clinicaltrials.gov
Start Date
March 6, 2020
End Date
May 19, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Campus Bio-Medico University
Responsible Party
Principal Investigator
Principal Investigator

Giulia Nonnis

Principal Investigator

Campus Bio-Medico University

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing elective cardiac surgery
  • Age over 18 years
  • 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)

Outcomes

Primary Outcomes

Maximum Pain Score

Time Frame: 24 hours

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

Secondary Outcomes

  • Respiratory performance at the TRI-FLOW(24 hours)
  • Time to first opioid(48 hours)
  • Intraoperative opioid administration(4 hours)
  • Total opioids consumption(24 hours)

Study Sites (1)

Loading locations...

Similar Trials