NCT06413290

Brief Summary

The aim of this study was to evaluate the effect of pectointercostal fascial plane block on regional haemodynamic parameters in patients undergoing cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

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

First Submitted

Initial submission to the registry

April 24, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

April 24, 2024

Last Update Submit

January 27, 2026

Conditions

Keywords

regional anesthesiapostoperative paindoppler ultrasoundcardiovascular surgery

Outcome Measures

Primary Outcomes (1)

  • blood volume

    The regional haemodynamic impact of PIDB block will be evaluated by Doppler ultrasound

    1 hour

Secondary Outcomes (3)

  • postoperative opioid consumption

    24 hours

  • postoperative Numerical Rating Scale (NRS) pain scores

    24 hours

  • length of hospital stay

    5 days

Study Arms (2)

PIFP block group

Before the anesthesia induction, PIFP block will be performed

Other: PIFP block group

Control group

No intervention

Other: Control group

Interventions

Ultrasound-guided PIFP block will be performed approximately 30 minutes before surgery in patients undergoing cardiac surgery

PIFP block group

No intervention

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

It is planned to include ASA I-III adult patients who are planned to undergo elective cardiac surgery

You may qualify if:

  • elective cardiac surgery
  • over 18 years, adult
  • American Society of Anaesthesiology (ASA) I-III

You may not qualify if:

  • history of cerebrovascular disease
  • history of Alzheimer's disease
  • mental disorder
  • emergency surgery
  • re-operated due to surgery-related complications
  • allergy to local anaesthetics
  • declining to give written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences, Antalya Training and Research Hospital

Antalya, Muratpaşa, Turkey (Türkiye)

Location

Related Publications (2)

  • Khera T, Murugappan KR, Leibowitz A, Bareli N, Shankar P, Gilleland S, Wilson K, Oren-Grinberg A, Novack V, Venkatachalam S, Rangasamy V, Subramaniam B. Ultrasound-Guided Pecto-Intercostal Fascial Block for Postoperative Pain Management in Cardiac Surgery: A Prospective, Randomized, Placebo-Controlled Trial. J Cardiothorac Vasc Anesth. 2021 Mar;35(3):896-903. doi: 10.1053/j.jvca.2020.07.058. Epub 2020 Jul 24.

    PMID: 32798172BACKGROUND
  • Ata F, Yilmaz C. Retrospective Evaluation of Fascial Plane Blocks in Cardiac Surgery With Median Sternotomy in a Tertiary Hospital. Cureus. 2023 Mar 3;15(3):e35718. doi: 10.7759/cureus.35718. eCollection 2023 Mar.

    PMID: 37016643BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Arzu O Karaveli, M.D.

    University of Health Sciences, Antalya Training and Researh Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2024

First Posted

May 14, 2024

Study Start

May 15, 2024

Primary Completion

December 12, 2025

Study Completion

December 30, 2025

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations