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

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

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Thoracic Cancer; Thoracotomy; Erector Spinae Plane Block
• Intervention / Treatment: Procedure: Thoracic Epidural Analgesia (TEA) group; Procedure: Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracic Epidural Analgesia (TEA) group; Patients in this group will receive Thoracic Epidural analgesia.	Procedure: Thoracic Epidural Analgesia (TEA) group; Under 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.
Experimental: 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).	Procedure: Thoracic Epidural Analgesia and Erector Spinae Plane Block (ESPB) group; Thoracic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with ipsilateral shoulder pain.	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.	one hour postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue analgesia	Time to first analgesic request after surgery in the form of intravenous morphine in a dose (0.05 mg/kg)	24 hours postoperatively
Changes in postoperative heart rate	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).	Preoperatively, intraoperatively, and 24 hours postoperatively
Changes in postoperative in mean arterial blood pressure	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).	Preoperatively, intraoperatively, and 24 hours postoperatively.
Total intra-operative fentanyl consumption.	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.	intraoperatively
Changes in postoperative oxygen saturation	Mean oxygen saturation at predetermined time intervals (1, 2, 6, 12 and 24 hours).	24 hours postoperatively
Complications occurrence	Adverse events as bradycardia, hypotension, failed block, local anesthetic toxicity, drowsiness and dizziness.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Muhammad Megahed, MSc, Cairo university

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Thoracic Neoplasms
• Other Study ID Numbers: AP2109-30108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study will be available upon a reasonable request from the corresponding author.
• IPD Sharing Time Frame: One year after the end of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No