Clinical trial NCT05238688: Efficacy of Ipsilateral High Thoracic Ultrasound-guided Erector Spinae Plane Block in Thoracic Cancer Surgeries
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracotomy
Erector Spinae Plane Block
Thoracic Cancer
Shoulder Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-02-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of patients with ipsilateral shoulder pain.
timeFrame: one hour postoperatively
Secondary outcomes:
measure: Time to first rescue analgesia
timeFrame: 24 hours postoperatively
measure: Changes in postoperative heart rate
timeFrame: Preoperatively, intraoperatively, and 24 hours postoperatively
measure: Changes in postoperative in mean arterial blood pressure
timeFrame: Preoperatively, intraoperatively, and 24 hours postoperatively.
measure: Total intra-operative fentanyl consumption.
timeFrame: intraoperatively
measure: Changes in postoperative oxygen saturation
timeFrame: 24 hours postoperatively
measure: Complications occurrence
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: Cairo University
name: Muhammad Megahed, MSc
role: PRINCIPAL_INVESTIGATOR
References: