Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Thoracic Cancer Surgeries

Cairo University (CU)

Status: Completed

Conditions: Shoulder Pain; Erector Spinae Plane Block; Thoracotomy; Thoracic Cancer

Treatments: Procedure: Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group; Procedure: Thoracic Epidural Analgesia (TEA) group

Study type: Interventional

Funder types: Other

Identifiers

NCT05238688

AP2109-30108

Details and patient eligibility

About

To evaluate the effectiveness of ultrasound guided Erector Spinae Plane Block (ESPB) in controlling post thoracotomy ipsilateral shoulder pain.

Full description

The aim of thoracotomy surgery is to explore the thoracic cavity and manage different pathologies including pulmonary, diaphragmatic, mediastinal, esophageal and vascular pathologies. It can be performed posterolaterally, anterolaterally or even anteriorly.

Post-thoracotomy Ipsilateral Shoulder Pain could undermine pain management in the post-thoracotomy patient.

Erector spinae plane block is a relatively novel block and was first described for chronic thoracic neuropathic pain in 2016. It is an inter-fascial plane block, but it may be classified as a paraspinal block due to its mechanism of action and injection site. It has been reported for a variety of indications, as in thoracic neuropathic pain and in postoperative analgesia after major open abdominal surgery. Erector spinae plane block has been successfully used to treat chronic shoulder pain, and the local anesthetic spread was reported to reach the level of C3 when it was performed at T2.

Ultrasound imaging made the practice of regional anesthesia easier in visualization and identification of usual and unusual position of nerves, blood vessels, needle during its passage through the tissues, as well as deposition and spread of local anesthetics in the desired plane and around the desired nerve.

Enrollment: 76 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. American Society of Anesthesiologists (ASA) physical status class I and II.
2. Age ≥ 18 and ≤ 60 Years.
3. Patients undergoing thoracic surgery e.g.: metastatectomy, lobectomy, pneumonectomy or pleuro-pneumonectomy.

Exclusion criteria

1. Patient refusal.
2. Local infection at the puncture site.
3. Coagulopathy with the international normalized ratio (INR) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities and deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).
4. Unstable cardiovascular disease.
5. History of psychiatric and cognitive disorders.
6. Patients allergic to medication used.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Thoracic Epidural Analgesia (TEA) group

Experimental group

Description:

Patients in this group will receive Thoracic Epidural analgesia.

Treatment:

Procedure: Thoracic Epidural Analgesia (TEA) group

Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group

Experimental group

Description:

Patients in this group will receive Thoracic Epidural analgesia in addition to high thoracic ultrasound-guided erector spinae plane block (ESPB).

Treatment:

Procedure: Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group