NCT04319588

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2020

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

March 9, 2020

Last Update Submit

February 6, 2023

Conditions

Cardiac DiseaseAnalgesiaAcute PainPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Maximum Pain Score

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

    24 hours

Secondary Outcomes (4)

  • Respiratory performance at the TRI-FLOW

    24 hours

  • Intraoperative opioid administration

    4 hours

  • Total opioids consumption

    24 hours

  • Time to first opioid

    48 hours

Study Arms (2)

Parasternal Group

EXPERIMENTAL

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

Case control group

ACTIVE COMPARATOR

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

Interventions

Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainagePROCEDURE

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.

Parasternal Group
Infiltration with local anesthetic of access to thoracic drainagePROCEDURE

Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.

Case control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing elective cardiac surgery
  • Age over 18 years
  • ASA I-IV
  • Approval by the patient of informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Biomedico University

Rome, Roma, 00128, Italy

Location

Related 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, 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.

    PMID: 26827847RESULT

MeSH Terms

Conditions

Heart DiseasesAgnosiaAcute PainPain, Postoperative

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPainPostoperative ComplicationsPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 24, 2020

Study Start

March 6, 2020

Primary Completion

May 9, 2020

Study Completion

May 19, 2020

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)