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Parasternal Block for Cardiac Surgery (Parasternal)

Primary Purpose

Cardiac Disease, Analgesia, Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage
Infiltration with local anesthetic of access to thoracic drainage
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Campus Biomedico University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Parasternal Group

Case control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 9, 2020
Last Updated
February 6, 2023
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT04319588
Brief Title
Parasternal Block for Cardiac Surgery
Acronym
Parasternal
Official Title
Parasternal Block for Postoperative Analgesia in Cardiac Surgery: a Pilot Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
May 9, 2020 (Actual)
Study Completion Date
May 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: Interventional (parasternal group) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Analgesia, Acute Pain, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parasternal Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Case control group
Arm Type
Active Comparator
Arm Description
The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.
Intervention Type
Procedure
Intervention Name(s)
Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Infiltration with local anesthetic of access to thoracic drainage
Intervention Description
Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.
Primary Outcome Measure Information:
Title
Maximum Pain Score
Description
Postoperative pain assessment using the NRS scale (score from 0 to 10)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Respiratory performance at the TRI-FLOW
Description
Respiratory performance is assessed by the number of balls raised during inspiration with the TRI-FLOW
Time Frame
24 hours
Title
Intraoperative opioid administration
Description
Quantitative evaluation of opioids needed in the intraoperative period
Time Frame
4 hours
Title
Total opioids consumption
Description
Number of opioid deliveries (bolus morphine) in the postoperative period
Time Frame
24 hours
Title
Time to first opioid
Description
The time in minutes between awakening and the first opioid administration
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Campus Biomedico University
City
Rome
State/Province
Roma
ZIP/Postal Code
00128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26827847
Citation
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.
Results Reference
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Parasternal Block for Cardiac Surgery

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