Skip to content

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

Evaluation the Effect of Ultrasound Guided Superficial, Deep Serratus Plane Blocks and Thoracic Epidural in Cancer Patients Undergoing Thoracotomy: A Prospective Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04189120
Enrollment
180
Registered
2019-12-06
Start date
2019-04-01
Completion date
2021-05-16
Last updated
2021-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-thoracotomy Pain Syndrome

Keywords

post thoracotomy pain, thoracic epidural, serratus anterior plane block, ultrasound

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.

Interventions

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

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

Sponsors

National Cancer Institute, Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
changes and stability of Mean Arterial Blood Pressure (MAP).every 5 minutes for 3 hours during the surgeyMean arterial blood pressure to be measured after completion of intervention in patients with thoracotomies then every five minutes till the end of surgery.

Secondary

MeasureTime frameDescription
Total intra-operative fentanyl consumption2-3 hours (Surgery time) surgerythe rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups
Pain scores using Visual analogue score24 hours after the surgeryPain 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.
1st time opioids requested post-operative.24 hours after the surgeryIn 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.
Total morphine consumption.24 hours after the surgeryThe total 24-hour morphine consumption will be recorded for every patient post operative.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026