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

NCT ID: NCT04189120

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-05-16

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.

Conditions

Post-thoracotomy Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Thoracic epidural analgesia (TEA)

Under full aseptic conditions and wearing sterile gloves while the patient is in setting position, skin infiltration will be done with 2 ml of 1% lidocaine, then an 18-G Epidural 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 or IV injection. After negative response, 15 ml of 0.25% epidural bupivacaine will be injected and the patient will be turned to the supine position.

Group Type: ACTIVE_COMPARATOR

Thoracic epidural analgesia , superficial serratus plane block and deep serratus plane block

Intervention Type: PROCEDURE

neuroaxial thoracic epidural analgesia and regional analgesia supeficial and deep serratus plane blocks

Ultrasound-guided superficial serratus plane block (SSPB)

Under full aseptic conditions, the patient is placed in lateral position with the diseased side up, sterile field is established with a povidone iodine solution, and the linear transducer 8-12 MH (sonosite M-turbo ; Inc., Bothell, WA, USA) is covered by a disposable sterile cover and will be placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The ribs will be counted until the fifth rib is identified in the mid-axillary line. The muscles will be identified easily overlying the fifth rib, the latissimus dorsi , teres major and serratus muscles . A skin wheal of 1% lidocaine will be made 1 cm away from the lateral edge of the transducer thorough which the needle (22-G, 50-mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle beneath the latissimus dorsi. Under continuous ultrasound guidance 30 ml of 0.25% bupivacaine will be injected

Group Type: ACTIVE_COMPARATOR

Thoracic epidural analgesia , superficial serratus plane block and deep serratus plane block

Intervention Type: PROCEDURE

neuroaxial thoracic epidural analgesia and regional analgesia supeficial and deep serratus plane blocks

Ultrasound-guided deep serratus plane block (DSPB)

Under full aseptic conditions, the patient is placed in lateral position with the diseased side up, sterile field is established with a povidone iodine solution, and the linear transducer 8-12 MH (sonosite M-turbo ; Inc., Bothell, WA, USA) is covered by a disposable sterile cover and will be placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The ribs will be counted until the fifth rib is identified in the mid-axillary line. A skin wheal of 1% lidocaine will be made 1 cm away from the lateral edge of the transducer thorough which the needle (22-G, 50-mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane between the posterior border of the serratus anterior muscle and the corresponding surface of the rib. Under continuous ultrasound guidance 30 ml of 0.25% bupivacaine will be injected deep to the serratus muscle separating the serratus anterior muscle from the external intercostal muscle.

Group Type: ACTIVE_COMPARATOR

Thoracic epidural analgesia , superficial serratus plane block and deep serratus plane block

Intervention Type: PROCEDURE

neuroaxial thoracic epidural analgesia and regional analgesia supeficial and deep serratus plane blocks

Interventions

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ekramy Mansour, MD

Role: STUDY_DIRECTOR

National Cancer Institute - Cairo University

Locations

National Cancer Institute - Cairo University

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 27939192 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23923989 (View on PubMed)

Other Identifiers

AP1811-30102

Identifier Type: -

Identifier Source: org_study_id