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Clinical Trials/NCT05191953
NCT05191953
Completed
N/A

Erector Spinae Plane Block Versus Its Combination With Superficial Parasternal Intercostal Plane Block for Postoperative Pain After Cardiac Surgery: A Prospective, Randomized, Double-blind Study

Ondokuz Mayıs University1 site in 1 country48 target enrollmentJanuary 26, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anesthesia
Sponsor
Ondokuz Mayıs University
Enrollment
48
Locations
1
Primary Endpoint
Morphine consumption in the first 24 hours after surgery
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 26, 2022
End Date
June 25, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

BURHAN DOST

Associate Professor

Ondokuz Mayıs University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Morphine consumption in the first 24 hours after surgery

Time Frame: Postoperative day 1

Morphine consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score ≥4.

Secondary Outcomes

  • Postoperative pain scores(Postoperative day 1)
  • Time to extubation(Postoperative day 1)
  • The number of patient requiring rescue analgesic(Postoperative Day 1)
  • The incidences of post-operative nausea and vomiting (PONV)(Postoperative Day 1)
  • Patient satisfaction as measured by the Revised American Pain Society Patient Outcome Questionnaire(Postoperative Day 1)
  • The number of patients with complications(Postoperative 7 days on an average)

Study Sites (1)

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