ESPB vs TPVB for Cardiac Surgery

July 25, 2023 updated by: Bahadir Ciftci, Medipol University

Comparison of Effectiveness of Erector Spinae Plane Block and Thoracal Paravertebral Block for Postoperative Analgesia After Cardiovascular Surgery: Randomized Study

Pain is a common and serious problem after cardiovascular surgery. It is associated with increased morbidity and mortality, and additional risk factors of cardiac surgery such as sternotomy and cardiopulmonary bypass contribute to this. Patient-controlled analgesia with intravenous opioids is standard in many centers for the management of pain after cardiac surgery. However, intravenous opioids have a higher risk of nausea and vomiting and may delay weaning from mechanical ventilation compared to regional techniques. Elderly patients have a higher risk of opioid-related complications, and regional techniques can help reduce postoperative ventilation time and accelerate postoperative recovery, which will reduce the risk of atelectasis, especially in the elderly population. Thoracic paravertebral block (TPVB) is difficult to apply due to its anatomical proximity to important structures such as the pleura and central neuraxial system, and may cause complications such as pneumothorax and vascular injury. Analgesia management is very important in these patients, since insufficient analgesia may cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption in the postoperative period.

Erector spina plane (ESP) block performed with ultrasound (US) is a new interfacial plane block defined by Forero et al. in 2016. If the ESP block is applied at the T5 level, it provides thoracic analgesia, if it is applied at the T7-9 level, it provides analgesia in the abdominal region.

In this study, it is aimed to compare the effectiveness of US-guided ESP block and TPVB for postoperative analgesia management after cardiovascular surgery. Our primary aim is to compare postoperative pain scores (NRS), and our secondary aim is to evaluate rescue analgesia using, opioid-related side effects (allergic reaction, nausea, vomiting) and complications that may occur due to block (pneumothorax, hematoma).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Pain is a common and serious problem after cardiovascular surgery. It is associated with increased morbidity and mortality, and additional risk factors of cardiac surgery such as sternotomy and cardiopulmonary bypass contribute to this. Patient-controlled analgesia with intravenous opioids is standard in many centers for the management of pain after cardiac surgery. However, intravenous opioids have a higher risk of nausea and vomiting and may delay weaning from mechanical ventilation compared to regional techniques. Elderly patients have a higher risk of opioid-related complications, and regional techniques can help reduce postoperative ventilation time and accelerate postoperative recovery, which will reduce the risk of atelectasis, especially in the elderly population. Thoracic paravertebral block (TPVB) is difficult to apply due to its anatomical proximity to important structures such as the pleura and central neuraxial system, and may cause complications such as pneumothorax and vascular injury. Analgesia management is very important in these patients, since insufficient analgesia may cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption in the postoperative period.

Erector spina plane (ESP) block performed with ultrasound (US) is a new interfacial plane block defined by Forero et al. in 2016. If the ESP block is applied at the T5 level, it provides thoracic analgesia, if it is applied at the T7-9 level, it provides analgesia in the abdominal region. This block is applied by injecting a solution containing local anesthetic into the fascia under the erector spina muscle. Since the application site of the ESP block is far from the pleura and neuraxial tissues, it minimizes the risk of complications due to injury to these structures. Sonoanatomy is easy to visualize on US and the spread of local anesthetic can be seen easily. With the cephalo-caudal spread of the local anesthetic solution, analgesia occurs in several dermatomes. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves and creates sensory blockade in both the anterolateral thorax and the posterior. In the literature, it has been reported that it provides effective analgesia in randomized controlled studies investigating the effectiveness of ESP block for postoperative analgesia management after open heart surgery, breast surgery and ventral hernia repair.

In this study, it is aimed to compare the effectiveness of US-guided ESP block and TPVB for postoperative analgesia management after cardiovascular surgery. Our primary aim is to compare postoperative pain scores (NRS), and our secondary aim is to evaluate rescue analgesia using, opioid-related side effects (allergic reaction, nausea, vomiting) and complications that may occur due to block (pneumothorax, hematoma).

Study Type

Interventional

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
    • Bagcilar
      • Istanbul, Bagcilar, Turkey, 34070
        • Istanbul Medipol University Hospital

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-III
  • Scheduled for cardiovascular surgery under general anesthesia

Exclusion Criteria:

  • Bleeding diathesis
  • anticoagulant treatment
  • local anesthetics and opioid allergy
  • Infection of the skin at the site of the needle puncture
  • Patients who do not accept the procedure

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Erector spinae block (Group ESPB)
ESP block will be applied in Group ESPB. The US probe will be placed longitudinally 2-3 cm lateral to the T5 transverse process. Three muscles from top to bottom; Trapezius at the top, rhomboid major in the middle, and the erector spina muscle at the bottom will be displayed over the hyperechoic transverse process. Using the in plane technique, the block needle will be advanced in the cranio-caudal direction and 5 ml of saline will be injected under the erector spina muscle and the block location will be confirmed. After the block location is confirmed, 40 ml of 0.25% bupivacaine will be administered (20 ml in each side).
Other: Postoperative management
1 g paracetamol will be administered 3 x 1. If the NRS score is ≥ 4, 1 mg kg-1 iv tramadol will be administrated.
Active Comparator: Thoracal paravertebral block group (Group TPVB)
After visualizing the T5 spinous process sagittally with the US probe, the probe will be placed 2-3 cm laterally. The ribs and transverse processes will be displayed as hyperechoic structures. Superiorly, the costotransverse ligament and anteriorly the pleura will be visualized. With the in-plane technique, the block needle will be advanced in the cranio-caudal direction until the costotransverse ligament is passed. 5 ml of saline will be injected and the block location will be confirmed. After confirming the location of the needle, negative aspiration is performed, and after observing the absence of CSF, blood and air, 40 ml of 0.25% bupivacaine will be administered, and it will be seen that the pleura is pushed down as the drug is administered (20 ml in each side).
Other: Postoperative management
1 g paracetamol will be administered 3 x 1. If the NRS score is ≥ 4, 1 mg kg-1 iv tramadol will be administrated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)
Time Frame: Postoperative 24 hours period
Change from Baseline Pain Scores at Postoperative 24 hours.
Postoperative 24 hours period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The need for rescue analgesia
Time Frame: Postoperative 24 hours period
The amount of Tramodol using (mg)
Postoperative 24 hours period

Collaborators and Investigators

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

Sponsor

Medipol University

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)

August 30, 2022

Primary Completion (Estimated)

May 30, 2023

Study Completion (Estimated)

June 30, 2023

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Medipol Hospital 28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared

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.

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