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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05238688
• Other study ID #: AP2109-30108
• Status: Completed
• Phase: N/A
• Start date: August 12, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erector Spinae Plane Block
• Shoulder Pain
• Thoracic Cancer
• Thoracic Neoplasms
• Thoracotomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	Changes in postoperative oxygen saturation	Mean oxygen saturation at predetermined time intervals (1, 2, 6, 12 and 24 hours).	24 hours postoperatively
Secondary	Complications occurrence	Adverse events as bradycardia, hypotension, failed block, local anesthetic toxicity, drowsiness and dizziness.	24 hours postoperatively