Recto-intercostal Fascial Plane Block and Pecto-intercostal Fascial Plane Block for Cardiac Surgery

NCT06285773 | Completed

• 1 other identifier: Medipol Hospital 36
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In cardiac surgeries performed with median sternotomy, mediastinal and thoracic tube placement sites are outside the area of effect of parasternal blocks, and sometimes the sternotomy incision extends below the T6 dermatome. Recto intercostal fascial plane block (RIFPB) has been defined as a complementary block for analgesia of this region. This study aims to evaluate the effectiveness of the combination of ultrasound-guided recto-intercostal fascial plane block and pectointercostal fascial block for postoperative analgesia management after open heart surgery (coronary artery bypass) with median sternotomy.

Conditions

Cardiac Disease

Keywords

Cardiac surgery; Postoperative analgesia management; Recto-intercostal fascial plane block; Pecto-intercostal fascial plane block

Outcome Measures

Primary Outcomes (1)

• Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")

  Change from Baseline Pain Scores at Postoperative 24 hours. Global QoR-15 Total: 150 (max) Physical Comfort 50 (max) Emotional State 40 (max) Psychological Support 20 (max) Physical Independence 20 (max) Pain 20 (max)

  Postoperative 24 hours period

Secondary Outcomes (3)

• Global recovery scoring system / Quality of Recovery 15 questionairre

  Change from baseline score at postoperative 24 hour

• The use of rescue analgesia

  Postoperative 24 hours period

• The use of rescue analgesia

  Postoperative 24 hours period

Study Arms (2)

Group PR = RIFPB and PIFB group

ACTIVE COMPARATOR

Recto-intercostal fascial plane block (RIFPB) and Pecto-intercostal fascial plane block (PIFB) will be applied

Drug: RIFPB block; Other: Postoperative analgesia management; Drug: PIFPB block

Group Control

OTHER

No block will be applied.

Other: Postoperative analgesia management

Interventions

RIFPB block DRUG

For RIFPB, a local anesthetic will be injected into the plane between the costal cartilage and the rectus abdominis muscle at the 6th-7th costal cartilage under US guidance. The in-plane technique will be used. After confirming the block location, 10 ml of 0.25% concentration marcaine (bupivacaine) will be used (bilateral).

Group PR = RIFPB and PIFB group

Postoperative analgesia management OTHER

Patients will be administered 10mg/kg paracetamol in the postoperative period every eight hours. If the NRS score is ≥ 4, 1 mg kg-1 iv tramadol will be administered as a rescue analgesic.

Group Control; Group PR = RIFPB and PIFB group

PIFPB block DRUG

For PIFPB; the ultrasound probe for PIFB is placed 2-3 cm lateral to the upper third of the sternum, parallel to the sternum. A local anesthetic of 15 ml of 0.25% concentration of marcaine (bupivacaine) will be used between the pectoralis major and external intercostal muscles (bilateral).

Group PR = RIFPB and PIFB group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-III
• Scheduled for cardiac surgery with elective median sternotomy under general anesthesia

You may not qualify if:

• a personal or family history of malignant hyperthermia,
• opioid sensitivity,
• alcohol or drug addiction,
• liver or kidney disease,
• skin infection in the area to be blocked,
• thoracic deformity,
• patients who are allergic to their medications,
• patients who do not agree to participate

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (4)

• Zhang Y, Gong H, Zhan B, Chen S. Effects of bilateral Pecto-intercostal Fascial Block for perioperative pain management in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2021 Jun 22;21(1):175. doi: 10.1186/s12871-021-01391-w.

  PMID: 34157970 BACKGROUND

• 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 BACKGROUND

• Elbardan IM, Shehab AS, Mabrouk IM. Comparison of Transversus Thoracis Muscle Plane Block and Pecto-Intercostal Fascial Plane Block for enhanced recovery after pediatric open-heart surgery. Anaesth Crit Care Pain Med. 2023 Aug;42(4):101230. doi: 10.1016/j.accpm.2023.101230. Epub 2023 Apr 7.

  PMID: 37031816 BACKGROUND

• Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Alver S, Sakul BU, Ansen G, Pence KB, Alici HA. Recto-intercostal fascial plane block: Another novel fascial plane block. J Clin Anesth. 2023 Oct;89:111163. doi: 10.1016/j.jclinane.2023.111163. Epub 2023 Jun 7. No abstract available.

  PMID: 37295124 BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and participant were blinded to the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for open heart surgery (coronary artery bypass) with median sternotomy will be included in the study. Patients will be randomly divided into two groups (Group PR = PIFPB + RIFPB group, Group C = Control group) including 30 patients each, before entering the operating room.

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 29, 2024
• Study Start: February 10, 2024
• Primary Completion: April 10, 2025
• Study Completion: April 20, 2025
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)