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

June 25, 2022 updated by: BURHAN DOST, Ondokuz Mayıs University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Atakum
      • Samsun, Atakum, Turkey, 55139
        • Ondokuz Mayis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group ESPB
A bilateral ESPB (40 ml, %0.25 bupivacaine, totally) + IV morphine-PCA
Procedure: Bilateral ultrasound-guided ESPB

Bilateral ultrasound-guided ESPB (total of 40 ml, 0.25% bupivacaine) will be performed.

Intraoperative analgesia:

At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV. Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20μg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose). In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day). For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation, in the intensive care unit.
Active Comparator: Group ESPB+Superficial PIPB
A bilateral ESPB (40 ml, %0.25 bupivacaine, totally) and a bilateral superficial PIPB (20 ml, %0.25 bupivacaine, totally) + IV morphine-PCA
Procedure: Bilateral ultrasound-guided ESPB and superficial PIPB

Bilateral ultrasound-guided ESPB (total of 40 ml, %0.25 bupivacaine) and Superficial PIPB (total of 20 ml, %0.25 bupivacaine) will be performed.

Intraoperative analgesia:

At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV. Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20μg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose). In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day). For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation, in the intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients with complications
Time Frame: Postoperative 7 days on an average
The number of patients have any complications -directly related to the block or the drug used in the block- will be recorded.
Postoperative 7 days on an average
Postoperative pain scores
Time Frame: Postoperative day 1
Pain at rest and while coughing will be assessed by numerical rating scale (NRS) scores at 0, 3, 6, 12, 18, and 24 hours after extubation. The NRS is an 11-point numeric scale that ranges from 0 to 10. The NRS is an 11-point scale consisting of integers from 0 to 10: 0 indicates "no pain" and 10 indicates "the worst pain ever possible." One day before the surgery, all patients will be informed about NRS and instructed on how to use a patient-controlled analgesia device.
Postoperative day 1
Time to extubation
Time Frame: Postoperative day 1
After the operation, the time until the patient is extubated will be recorded.
Postoperative day 1
The number of patient requiring rescue analgesic
Time Frame: Postoperative Day 1
The number of patients who required rescue analgesics will be recorded at 0, 3, 6, 12, 18, and 24 hours after extubation.
Postoperative Day 1
The incidences of post-operative nausea and vomiting (PONV)
Time Frame: Postoperative Day 1
The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more ondansetron 4 mg IV will be administered and will repeat after 8 hours if required.The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
Postoperative Day 1
Patient satisfaction as measured by the Revised American Pain Society Patient Outcome Questionnaire
Time Frame: Postoperative Day 1

The Revised American Pain Society Patient Outcome Questionnaire will be used to assess satisfaction with pain expectation counseling (APS-POQ-R). The APS-POQ-R is designed for use in adult hospital pain management quality improvement activities, and it assesses six aspects of care: (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) usefulness of pain treatment information; (5) ability to participate in pain treatment decisions; and (6) use of nonpharmacological strategies.

Participants will rate themselves on a scale of 0 to 10. They were either severely dissatisfied or extremely satisfied, with a score of 0 indicating extreme dissatisfaction and 10 indicating extreme satisfaction.

APS-POQ-R Turkish Version will be used for assessment.
Postoperative Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

  • Study Director: BURHAN DOST, Ondokuz Mayıs University Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2022

Primary Completion (Actual)

May 17, 2022

Study Completion (Actual)

June 25, 2022

Study Registration Dates

First Submitted

December 29, 2021

First Submitted That Met QC Criteria

January 13, 2022

First Posted (Actual)

January 14, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 25, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESPBPIPB0255

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Analgesia

Clinical Trials on Bilateral ultrasound-guided ESPB

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe