ESPB vs TPVB for Cardiac Surgery

NCT05476393 | Withdrawn

• 1 other identifier: Medipol Hospital 28
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Diseases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)

  Change from Baseline Pain Scores at Postoperative 24 hours.

  Postoperative 24 hours period

Secondary Outcomes (1)

• The need for rescue analgesia

  Postoperative 24 hours period

Study Arms (2)

Erector spinae block (Group ESPB)

ACTIVE COMPARATOR

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

Thoracal paravertebral block group (Group TPVB)

ACTIVE COMPARATOR

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

Interventions

Postoperative management OTHER

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

Erector spinae block (Group ESPB); Thoracal paravertebral block group (Group TPVB)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (4)

• El Shora HA, El Beleehy AA, Abdelwahab AA, Ali GA, Omran TE, Hassan EA, Arafat AA. Bilateral Paravertebral Block versus Thoracic Epidural Analgesia for Pain Control Post-Cardiac Surgery: A Randomized Controlled Trial. Thorac Cardiovasc Surg. 2020 Aug;68(5):410-416. doi: 10.1055/s-0038-1668496. Epub 2018 Aug 16.

  PMID: 30114712 BACKGROUND

• Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.

  PMID: 30052229 BACKGROUND

• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

  PMID: 27501016 BACKGROUND

• D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.

  PMID: 29169795 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

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

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: August 30, 2022
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)