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

Cardiovascular Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06413290
• Other study ID #: 18/12
• Status: Recruiting
• Start date: May 15, 2024
• Est. completion date: October 29, 2024

Study information

• Verified date: April 2024
• Source: Antalya Training and Research Hospital
• Contact: Arzu Karaveli
• Phone: +90 2422494400
• Email: arzukaraveli[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 29, 2024
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Surgery

Intervention

Other:
• PIFP block group
Ultrasound-guided PIFP block will be performed approximately 30 minutes before surgery in patients undergoing cardiac surgery
• Control group
No intervention

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Antalya Training and Research Hospital	Antalya	Muratpasa

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood volume	The regional haemodynamic impact of PIDB block will be evaluated by Doppler ultrasound	1 hour
Secondary	postoperative opioid consumption	The amount of postoperative opioid consumption will be recorded	24 hours
Secondary	postoperative Numerical Rating Scale (NRS) pain scores	The postoperative pain intensity will be assessed with NRS pain scores (0=no pain, 10=worst possible pain)	24 hours
Secondary	length of hospital stay	The interval from the end of the surgery until the patient's discharge will be recorded.	5 days