Clinical Trials Directory

Trials / Completed

CompletedNCT05238688

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

Evaluation of the Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Preventing Post-thoracotomy Shoulder Pain in Thoracic Cancer Surgeries: A Prospective Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
76 (actual)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
PROCEDUREThoracic Epidural Analgesia (TEA) groupUnder full aseptic conditions while the patient is in setting position, skin infiltration will be done with 2 ml of 1% lidocaine an 18-G Tuohy needle with a 20-G catheter (Perifix, B.Braun, Germany) will be inserted through the T6-T7 interspace, and the epidural space located using the loss of resistance technique. The catheter then advanced approximately 3 cm cephalic. A test dose of 3 ml of 1% lidocaine containing epinephrine in a ratio of 1:200,000 administered to detect unintentional intrathecal . After negative response, 15 ml of 0.25% epidural bupivacine will be injected and the patient will be turned to the supine position.
PROCEDUREThoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) groupThoracic Epidural Analgesia will be done at first. Then, the ultrasound probe will be placed longitudinally 2-3 cm lateral to the T2 spinous process in the sagittal line. The T2 spinous process will be identified by counting down anatomically from the vertebral prominens (C7), and the T2 transverse process will be visualized by counting down from the first rib via real-time ultrasound guidance. The erector spinae muscle will be visualized above the T2 transverse process. The needle will be inserted in a caudal cranial direction using the in-plane technique. A dose of 5 mL normal saline will be injected into the inter-fascial area between the erector spinae muscle and the transverse process for the correction of the injection site (hydro-dissection). After hydro-dissection, 15 mL of 0.25% bupivacaine will be injected here, and the linear spread of the solution will be visualized in the inter-fascial plane.

Timeline

Start date
2022-08-12
Primary completion
2023-08-01
Completion
2023-08-01
First posted
2022-02-14
Last updated
2024-02-07

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05238688. Inclusion in this directory is not an endorsement.