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ESPB vs.Combination of ESPB and Superficial PIPB in Cardiac Surgery

O

Ondokuz Mayıs University

Status

Completed

Conditions

Analgesia
Acute Pain
Patient Controlled Analgesia
Anesthesia

Treatments

Procedure: Bilateral ultrasound-guided ESPB and superficial PIPB
Procedure: Bilateral ultrasound-guided ESPB

Study type

Interventional

Funder types

Other

Identifiers

NCT05191953
ESPBPIPB0255

Details and patient eligibility

About

Cardiac surgery is associated with significant postoperative pain. Pain control is an essential part of enhanced recovery protocols. The aim of this study is to evaluate and compare the analgesic efficacies of erector spinae plane block (ESPB) and the combination of ESPB and superficial parasternal intercostal plane block (PIPB) in patients undergoing elective cardiac surgery.

Full description

Many regional techniques have been used to manage postoperative pain in cardiac surgery, including thoracic epidural anesthesia, paravertebral, intercostal nerve block, intrathecal spinal morphine, and local infiltration. Increased risk of epidural/spinal hematoma secondary to systemic heparinization, potential hemodynamic instability, technical difficulties and complications such as pneumothorax are potential serious drawbacks. Due to the aforementioned reasons, anesthetists are understandably preferring ultrasound (US) guided interfascial plane blocks, which are generally thought to provide safer and more effective analgesia in cardiac surgery.

This study aims to evaluate and compare the effects of ESPB versus ESPB plus Superficial PIPB on pain scores and opioid consumption in patients undergoing elective cardiac surgery.

Patients will be divided into two groups:

Group ESPB:

In this group, patients will be administered bilateral ESPB (total of 40 ml, %0.25 bupivacaine) in addition to IV morphine patient-controlled analgesia (PCA) for the first 24 postoperative hours.

Group ESPB+Superficial PIPB:

In this group, patients will be administered Bilateral ESPB (total of 40 ml, %0.25 bupivacaine) and bilateral Superficial PIPB (total of 20 ml, %0.25 bupivacaine). In addition, IV morphine PCA will be administered for the first 24 postoperative hours.

Enrollment

48 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • American Society of Anesthesiologists (ASA) 2-3 patients between the ages of 18-80 who are scheduled for elective cardiac surgery (coronary artery bypass graft surgery +/- valve replacement or isolated valve surgery)
  • BMI <35 kg / m2

Exclusion criteria

  • Emergent surgeries, redo cases, minimally invasive procedures
  • Patients who do not want to participate
  • Patients with cognitive dysfunction (patients who are not able to evaluate the verbal numerical pain scale)
  • Hypersensitivity or history of allergies to local anesthetics
  • Major liver or kidney dysfunction or other pre-existing major organ dysfunction
  • Left ventricular ejection fraction <30
  • Individuals with mental health disorders (for example bipolar disorder or depression)
  • Pregnancy or breastfeeding
  • Presence of hematological disease
  • Patients with alcohol-drug addiction

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

48 participants in 2 patient groups

Group ESPB
Active Comparator group
Description:
A bilateral ESPB (40 ml, %0.25 bupivacaine, totally) + IV morphine-PCA
Treatment:
Procedure: Bilateral ultrasound-guided ESPB
Group ESPB+Superficial PIPB
Active Comparator group
Description:
A bilateral ESPB (40 ml, %0.25 bupivacaine, totally) and a bilateral superficial PIPB (20 ml, %0.25 bupivacaine, totally) + IV morphine-PCA
Treatment:
Procedure: Bilateral ultrasound-guided ESPB and superficial PIPB

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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