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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04319588
Other study ID # 20/20 PAR ComEt CBM
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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