Skip to content

ESPB vs TPVB for Cardiac Surgery

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05476393
Enrollment
0
Registered
2022-07-27
Start date
2022-08-30
Completion date
2023-06-30
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

Cardiovascular surgery, Postoperative pain management, Erector Spinae Plane Block, Thoracal paravertebral block

Brief summary

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).

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).

Interventions

1 g paracetamol will be administered 3 x 1. If the NRS score is ≥ 4, 1 mg kg-1 iv tramadol will be administrated.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.

Intervention model description

There are two models for this study. The first group is erector spinae plane block group. The second one is thoracal paravertebral block group.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)Postoperative 24 hours periodChange from Baseline Pain Scores at Postoperative 24 hours.

Secondary

MeasureTime frameDescription
The need for rescue analgesiaPostoperative 24 hours periodThe amount of Tramodol using (mg)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026