Fascial Plane Blocks and Quality of Recovery in Cardiac Surgery

NCT07557108 | Recruiting

• 1 other identifier: OrduU-AR-YI-01
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized trial, the investigators will test the hypothesis that combining regional analgesia techniques-which have the potential to improve the quality of postoperative recovery following median sternotomy-with PIFB will accelerate recovery. Additionally, it is anticipated that RIFB, an alternative fascial plane block, will demonstrate non-inferior (at least as effective as) performance compared to RSB, thereby providing flexibility and ease of application in clinical practice.

Conditions

Cardiovascular Surgical Procedures; Cardiovascular Diseases; Pain, Postoperative

Keywords

Cardiovascular Surgical Procedures; Anesthesia, Conduction; Acute Postoperative Pain; Pain Management; Enhanced Recovery After Surgery; Anesthesia, Regional

Outcome Measures

Primary Outcomes (1)

• Turkish version of the Quality of Recovery-15 scale (QoR-15T)

  The QoR-15T scale consists of a total of 15 items, each scored on a 0-10 scale (a 11-point Likert-type scale). The total score ranges from 0 (very poor recovery) to 150 (excellent recovery). While total scores of 118 and above are generally accepted in the literature as an indicator of 'good recovery,' scores can also be classified as 136-150 (excellent), 122-135 (good), 90-121 (moderate), and 0-89 (poor). The scale covers five domains: physical comfort (items 1-4 and 13), emotional state (items 9, 10, 14, and 15), psychological support (items 6 and 7), physical independence (items 5 and 8), and pain (items 11 and 12).

  In the postoperative period, the time of extubation will be considered "postoperative hour 0". The primary endpoint is the quality of early recovery, assessed at 24 hours postoperatively.

Secondary Outcomes (5)

• Turkish version of the Quality of Recovery-15 scale (QoR-15T)

  In the postoperative period, the time of extubation will be considered "postoperative hour 0". QoR-15T scores will be reassessed at 48 hours postoperatively and prior to discharge.

• The Numerical Rating Scale (NRS)

  All cases will be assessed using the NRS at 0, 3, 6, 12, 24, 36, and 48 hours after extubation.

• Total Tramadol Consumption

  Total tramadol consumption will be recorded during the first 48 hours post-extubation to evaluate opioid use.

• Opioid-Related Adverse Effects During the Postoperative Observation Phase

  Until hospital discharge (approximately 5-7 days)

• Complications Associated with Fascial Plane Blocks

  Until hospital discharge (approximately 5-7 days)

Study Arms (3)

Group P

Bilateral pectointercostal fascial plane block (PIFB) will be administered.

Procedure: Ultrasound-Guided Pectointercostal Fascial Plane Block

Group PRS

Bilateral rectus sheath block (RSB) will be administered in addition to bilateral PIFB.

Procedure: Ultrasound-Guided Pectointercostal Fascial Plane Block; Procedure: Ultrasound-Guided Rectus Sheath Block

Group PRI

Bilateral retro-intercostal fascial plane block (RIFB) will be administered in addition to bilateral PIFB.

Procedure: Ultrasound-Guided Pectointercostal Fascial Plane Block; Procedure: Ultrasound-Guided Recto-Intercostal Fascial Plane Block

Interventions

Ultrasound-Guided Pectointercostal Fascial Plane Block PROCEDURE

Following anesthesia induction, bilateral pectointercostal fascial plane block (PIFB) will be performed under steril conditions using a high-frequency linear US probe positioned parallel to the parasternal region. The second and fourth ribs will be identified in the parasternal region under US guidance. A 100-mm echogenic peripheral nerve block needle will be advanced craniocaudally toward the fourth rib using an in-plane technique to reach the fascial plane between the pectoralis major and intercostal muscles. After confirming the target plane via hydrodissection, 20 mL of 0.25% bupivacaine will be injected into the fascial plane on each side (total 40 mL). The success of the block will be confirmed by sliding the US probe craniocaudally to directly visualize the local anesthetic spread between the pectoralis major fascia and the intercostal muscles (extending from the first to the sixth rib).

Group P; Group PRI; Group PRS

Ultrasound-Guided Rectus Sheath Block PROCEDURE

Bilateral rectus sheath block (RSB) will be performed at the end of surgery. A high-frequency linear US probe will be positioned in the epigastric region, 2-3 cm below the xiphoid process and immediately below the chest tubes, intersecting the linea alba perpendicularly. After identifying the anatomical structures (anterior rectus abdominis sheath, muscle, posterior sheath, and peritoneum) with the US probe, a 100-mm echogenic peripheral block needle will be advanced into the plane between the rectus abdominis muscle and the posterior sheath using an in-plane technique. After confirming the needle tip location via hydrodissection, a total of 20 mL of 0.25% bupivacaine (10 mL per side) will be injected into the fascial plane. Block success will be confirmed by direct visualization of the "double V"-shaped echogenic pattern formed by the spread of the local anesthetic between the fascial planes.

Group PRS

Ultrasound-Guided Recto-Intercostal Fascial Plane Block PROCEDURE

Bilateral recto-intercostal fascial plane block (RIFB) will be performed at the end of surgery. A high-frequency linear US probe will be positioned in the sagittal plane, 3-4 cm lateral and 3-4 cm caudal to the xiphoid process. After identifying the sixth and seventh costal cartilages and the rectus abdominis muscle, a 100-mm echogenic peripheral block needle will be advanced caudo-cranially using an in-plane technique to reach the plane between the rectus abdominis muscle and the costal cartilage. After confirming the needle tip location via hydrodissection, a total of 20 mL of 0.25% bupivacaine (10 mL per side) will be injected into the fascial plane. Block success will be confirmed by direct visualization of the local anesthetic spread in a cranio-caudal direction.

Group PRI

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 18-70 years, with ASA physical status II-III, who are scheduled to undergo elective open-heart surgery via median sternotomy with cardiopulmonary bypass at a tertiary care city hospital.

You may qualify if:

• Patients who have provided written informed consent
• Open-heart surgery performed under elective conditions via median sternotomy with cardiopulmonary bypass (on-pump)
• American Society of Anesthesiologists (ASA) physical status class II or III
• Aged 18-70 years

You may not qualify if:

• Off-pump surgical procedure
• Emergency or repeat cardiac surgery
• Known allergy to induction agents or local anesthetics
• Body mass index (BMI) \>35 kg/m²
• Coagulopathy
• Infection at the surgical site
• Left ventricular ejection fraction (LVEF) \<40%
• Renal insufficiency (estimated glomerular filtration rate \<60 mL/min/1.73 m²) or hepatic insufficiency \[Presence of major systemic diseases such as acute decompensated cirrhosis characterized by bilirubin \>12 mg/dL, INR \>2.5, or hepatic encephalopathy, in accordance with the European Association for the Study of the Liver-Chronic Liver Failure Consortium criteria\]
• Psychiatric disorders
• History of chronic pain or regular use of analgesics (corticosteroids, analgesics, anticonvulsants)
• Cognitive impairments that could interfere with the assessment of postoperative pain
• Patients with impaired physical and verbal performance

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Name: Ordu University Training and Research Hospital

Ordu, Altinordu, 52200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Cardiovascular Diseases; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 29, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

TU (1)