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

Not Applicable

Completed

• Conditions: Shoulder Pain; Erector Spinae Plane Block; Thoracotomy; Thoracic Cancer
• Interventions: Procedure: Thoracic Epidural Analgesia (TEA) group; Procedure: Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group

• Registration Number: NCT05238688
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-14
• Study Start: 2022-08-12
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracic Epidural Analgesia (TEA) group	Thoracic Epidural Analgesia (TEA) group	Patients in this group will receive Thoracic Epidural analgesia.
Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group	Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group	Patients in this group will receive Thoracic Epidural analgesia in addition to high thoracic ultrasound-guided erector spinae plane block (ESPB).

Primary Outcome Measures

Name	Time	Method
Percentage of patients with ipsilateral shoulder pain.	one hour postoperatively	Percentage of patients with ipsilateral shoulder pain with a Visual Analogue Scale (VAS) ≥ 3 where (0 = no pain and 10 = severe pain) in the first postoperative hour.

Secondary Outcome Measures

Name	Time	Method
Time to first rescue analgesia	24 hours postoperatively	Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg)
Changes in postoperative heart rate	Preoperatively, intraoperatively, and 24 hours postoperatively	Heart rate will be recorded before block performance and before induction of anesthesia, intraoperatively every 10 min till the end of surgery and after surgery at T (30 min in Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 24 hours).
Changes in postoperative in mean arterial blood pressure	Preoperatively, intraoperatively, and 24 hours postoperatively.	Mean arterial blood pressure will be recorded before block performance and before induction of anesthesia, intraoperatively every 10 min till the end of surgery and after surgery at T (30 min in Post-Anesthesia Care Unit (PACU), 2, 4, 6, 12, 24 hours).
Total intra-operative fentanyl consumption.	intraoperatively	In case of an elevation of heart rate or mean arterial blood pressure ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg.
Changes in postoperative oxygen saturation	24 hours postoperatively	Mean oxygen saturation at predetermined time intervals (1, 2, 6, 12 and 24 hours).
Complications occurrence	24 hours postoperatively	Adverse events as bradycardia, hypotension, failed block, local anesthetic toxicity, drowsiness and dizziness.

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt