Doppler Evaluation of Ultrasound-guided Pectointercostal Fascial Plane Block in Cardiac Surgery

May 17, 2024 updated by: Antalya Training and Research Hospital
The aim of this study was to evaluate the effect of pectointercostal fascial plane block on regional haemodynamic parameters in patients undergoing cardiac surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Perioperative pain management has become an important component of Enhanced Recovery After Surgery (ERAS) protocols in patients undergoing cardiac surgery. Pain is most intense in the first two days after cardiac surgery. Inadequate pain control has been shown to cause an increase in pulmonary complications due to inadequate mobility and coughing, an increase in sympathetic activation, an increase in myocardial infarction and thromboembolic events, delayed wound healing, and prolonged hospital and intensive care unit stay. Non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, opioids, epidural anesthesia and ultrasound-guided fascial plane blocks are widely used for pain management after cardiac surgery. The pectointercostal fascial plane (PIFP) block is an ultrasound-guided, superficial fascial plane block that can be applied as part of multimodal postoperative analgesia, especially after cardiac surgery. PIFB block has been shown to reduce postoperative analgesic consumption and improve pain scores not only in patients undergoing cardiac surgery but also in non-cardiac surgeries and thoracic procedures. The aim of this study was to evaluate the effect of PIFP block on regional haemodynamic parameters in patients undergoing cardiac surgery.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Muratpaşa
      • Antalya, Muratpaşa, Turkey
        • Recruiting
        • University of Health Sciences, Antalya Training and Research Hospital
        • Contact:
          • Antalya Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
No intervention
Other: Control group
No intervention
PIFP block group
Before the anesthesia induction, PIFP block will be performed
Other: PIFP block group
Ultrasound-guided PIFP block will be performed approximately 30 minutes before surgery in patients undergoing cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood volume
Time Frame: 1 hour
The regional haemodynamic impact of PIDB block will be evaluated by Doppler ultrasound
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative opioid consumption
Time Frame: 24 hours
The amount of postoperative opioid consumption will be recorded
24 hours
postoperative Numerical Rating Scale (NRS) pain scores
Time Frame: 24 hours
The postoperative pain intensity will be assessed with NRS pain scores (0=no pain, 10=worst possible pain)
24 hours
length of hospital stay
Time Frame: 5 days
The interval from the end of the surgery until the patient's discharge will be recorded.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antalya Training and Research Hospital

Investigators

  • Study Director: Arzu O Karaveli, M.D., University of Health Sciences, Antalya Training and Researh Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

September 29, 2024

Study Completion (Estimated)

October 29, 2024

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18/12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiovascular Surgery

Clinical Trials on Control group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe