Clinical trial NCT04189120: The Effect of Ultrasound Guided Superficial, Deep Serratus Plane Blocks and Thoracic Epidural in Thoracotomy
Official title: Evaluation the Effect of Ultrasound Guided Superficial, Deep Serratus Plane Blocks and Thoracic Epidural in Cancer Patients Undergoing Thoracotomy: A Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-thoracotomy Pain Syndrome
Keywords: post thoracotomy pain
thoracic epidural
serratus anterior plane block
ultrasound
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2019-12-06
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pain after thoracotomy is known to be sever acute pain that is resulted from retraction, resection or fracture of ribs .This pain increases post operative morbidity and if not properly managed peri-operatively, chronic post thoracotomy pain syndrome may develop. Different methods are described to manage post thoracotomy pain.Thoracic epidural analgesia is believed to be the corner stone in the peri-operative care for thoracotomy providing the most effective analgesia. Serratus anterior plane (SAP) block has recently been described as a regional anesthetic technique to provide analgesia for thoracic wall surgeries. During SAP block, local anesthesia are deposited in the fascial plane either superficial to the serratus muscle or deep to the serratus anterior muscle in the mid-axillary line . Serratus anterior block provides analgesia to a hemithorax by blocking the lateral branches of the intercostal nerves. This study aims To compare the effect of superficial, deep serratus plane blocks and thoracic epidural analgesia in maintaining hemodynamic and controlling post thoracotomy 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.

Pain after thoracotomy is known to be sever acute pain that is resulted from retraction, resection or fracture of ribs and dislocation of costovertebral joints; injury of intercostal nerves or even irritation of the pleura by chest tubes inserted at the end of surgery. This pain increases post-operative morbidity and if not properly managed peri-operatively, chronic post thoracotomy pain syndrome may develop.

Different methods are described to manage post thoracotomy pain. Intravenous (IV) drugs such as opioids and non-steroidal anti-inflammatory drugs (NSAIDS), infiltration of local anesthetics to the wound and regional anesthetic techniques such as thoracic epidural analgesia (TEA), paravertebral block, intercostal block and intra/extra pleural block are methods frequently used to relieve post thoracotomy pain.

Thoracic epidural analgesia is believed to be the corner stone in the peri-operative care for thoracotomy providing the most effective analgesia. However, thoracic epidural analgesia is associated with serious complications such as hypotension, dural puncture with the needle or the catheter, post-dural puncture headache, respiratory depression with adding opioids, spinal cord injury and anterior spinal artery syndrome.

The serratus muscle is a superﬁcial and easily identified muscle that is considered a true landmark to implement thoracic wall blocks because the intercostal nerves pierce it.Serratus anterior plane (SAP) block has recently been described as a regional anesthetic technique to provide analgesia for breast and thoracic wall surgeries. During SAP block, local anesthesia are deposited in the fascial plane either superficial to the serratus muscle or deep to the serratus anterior muscle in the mid-axillary line .Serratus anterior block provides analgesia to a hemithorax by blocking the lateral branches of the intercostal nerves.SAP block is also expected to avoid autonomic blockade associated with TEA and other complications involving the pleura and central neuraxial structures.

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. ASA(American Society of Anesthesia) class I and II.
2. Age ≥ 18 and ≤ 60 Years.
3. Patients undergoing thoracic surgery eg: lobectomy, pneumonectomy or pleuro-pneumonectomy

Exclusion Criteria:

1. Patient refusal.
2. Local infection at the puncture site.
3. Coagulopathy with INR ( international normalized ratio ) ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities \& 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: changes and stability of Mean Arterial Blood Pressure (MAP).
timeFrame: every 5 minutes for 3 hours during the surgey
Secondary outcomes:
measure: Total intra-operative fentanyl consumption
timeFrame: 2-3 hours (Surgery time) surgery
measure: Pain scores using Visual analogue score
timeFrame: 24 hours after the surgery
measure: 1st time opioids requested post-operative.
timeFrame: 24 hours after the surgery
measure: Total morphine consumption.
timeFrame: 24 hours after the surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute - Cairo University
Study officials:
affiliation: National Cancer Institute - Cairo University
name: Ekramy Mansour, MD
role: STUDY_DIRECTOR
References:
citation: Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21.
citation: Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.