Actively Recruiting
Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy: A Randomized Controlled Trial
Led by Cairo University · Updated on 2025-04-17
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare awake thoracic epidural anesthesia with general anesthesia for patients undergoing thoracotomy, a major chest surgery. The study addresses the high incidence of chronic pain after thoracotomy, which is often linked to severe acute postoperative pain. Effective pain management is crucial for these patients, and while thoracic epidural analgesia is commonly used alongside general anesthesia, its use as the sole anesthesia method in major thoracic surgery is rare. Participants will be randomly assigned to receive either awake thoracic epidural anesthesia before surgery or general anesthesia during thoracotomy. These two approaches are being studied to evaluate their impact on patient outcomes during and after surgery. During the study, researchers will assess changes in lung function 24 hours after surgery as the primary outcome. Secondary outcomes include heart rate and blood pressure during surgery, pain levels, opioid use, timing of first rescue pain medication, and the occurrence of any side effects within 48 hours postoperatively. The study will monitor participants closely through surgery and the immediate recovery period to gather this data.
CONDITIONS
Brief Title
Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75 years old
- Both genders
- American Society of Anesthesiologists (ASA) physical status classification II or III
- Scheduled for thoracotomy
You will not qualify if you...
- Difficult airway management
- Hemodynamically unstable patients
- Obesity with body mass index over 30
- Absolute contraindications to thoracic epidural anesthesia such as patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural
- Neurological disorders including risk of seizure, inability to cooperate, intracranial mass or brain edema
- Extensive pleural adhesions or previous pulmonary resections
- Hypoxemia (PaO2 less than 60) or hypercarbia (PaCO2 greater than 50)
- Poor cardiac function (ejection fraction less than 50%)
- Poor pulmonary function tests
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 hours (duration of surgery and anesthesia)
Participants receive either awake thoracic epidural anesthesia or general anesthesia before thoracotomy surgery.
1 treatment visit (in-person)
Duration - 48 hours postoperatively
Participants are monitored for postoperative pain, pulmonary function, adverse events, and other outcomes after surgery.
Approximately 2 post-operative visits
Trial Site Locations
Total: 1 location
1
Cairo University
Cairo, Egypt, 12613
Actively Recruiting
Research Team
M
Mohamed E Abdel Fattah, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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