The Effect of Ultrasound Guided Superficial, Deep Serratus Plane Blocks and Thoracic Epidural in Thoracotomy

Post-thoracotomy Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04189120
• Other study ID #: AP1811-30102
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: May 16, 2021

Study information

• Verified date: June 2021
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 16, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post-thoracotomy Pain Syndrome

Intervention

Procedure:
• Thoracic epidural analgesia , superficial serratus plane block and deep serratus plane block
neuroaxial thoracic epidural analgesia and regional analgesia supeficial and deep serratus plane blocks

Locations

Country	Name	City	State
Egypt	National Cancer Institute - Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes and stability of Mean Arterial Blood Pressure (MAP).	Mean arterial blood pressure to be measured after completion of intervention in patients with thoracotomies then every five minutes till the end of surgery.	every 5 minutes for 3 hours during the surgey
Secondary	Total intra-operative fentanyl consumption	the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups	2-3 hours (Surgery time) surgery
Secondary	Pain scores using Visual analogue score	Pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals (1, 2, 6, 12 and 24h) postoperative.	24 hours after the surgery
Secondary	1st time opioids requested post-operative.	In case of postoperative pain recorded, rescue analgesia will be provided as IV morphine (3 mg) then continuous infusion of morphine through Patient Controlled Analgesia ( PCA ) to keep the VAS scores<3. The total 24-hour morphine consumption will be recorded for every patient.	24 hours after the surgery
Secondary	Total morphine consumption.	The total 24-hour morphine consumption will be recorded for every patient post operative.	24 hours after the surgery