## Protocol Section
### Identification Module
**NCT ID:** NCT06413290

**Brief Title:** Doppler Evaluation of Ultrasound-guided Pectointercostal Fascial Plane Block in Cardiac Surgery

**Official Title:** Doppler Evaluation of Ultrasound-guided Pectointercostal Fascial Plane Block in Cardiac Surgery

#### Organization Study ID Info
**ID:** 18/12
#### Organization
**Class:** OTHER_GOV
**Full Name:** Antalya Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-10-29

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09-29

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-15

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Antalya Training and Research Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Cardiovascular Surgery

**Keywords:**

- regional anesthesia

- postoperative pain

- doppler ultrasound

- cardiovascular surgery

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Before the anesthesia induction, PIFP block will be performed

**Intervention Names:**

- Other: PIFP block group

**Label:** PIFP block group

#### Arm Group 2

**Description:** No intervention

**Intervention Names:**

- Other: Control group

**Label:** Control group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PIFP block group

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

**Name:** PIFP block group

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control group

**Description:** No intervention

**Name:** Control group

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** blood volume

**Time Frame:** 1 hour

#### Secondary Outcomes

**Description:** The amount of postoperative opioid consumption will be recorded

**Measure:** postoperative opioid consumption

**Time Frame:** 24 hours

**Description:** The postoperative pain intensity will be assessed with NRS pain scores (0=no pain, 10=worst possible pain)

**Measure:** postoperative Numerical Rating Scale (NRS) pain scores

**Time Frame:** 24 hours

**Description:** The interval from the end of the surgery until the patient's discharge will be recorded.

**Measure:** length of hospital stay

**Time Frame:** 5 days

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** arzukaraveli@hotmail.com

**Name:** Arzu Karaveli

**Phone:** +90 2422494400

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Antalya

**Contacts:**

***Contact 1:***

- **Name:** Antalya Training and Research Hospital

- **Role:** CONTACT

**Country:** Turkey

**Facility:** University of Health Sciences, Antalya Training and Research Hospital

**State:** Muratpaşa

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** University of Health Sciences, Antalya Training and Researh Hospital

**Name:** Arzu O Karaveli, M.D.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**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.

**PMID:** 32798172

**Citation:** 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:** 37016643

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
