Comparing awake thoracic epidural anesthesia to general anesthesia for thoracotomy
Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy: A Randomized Controlled Trial
This study is testing whether awake thoracic epidural anesthesia can help people having thoracotomy surgery manage pain better than general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06930183 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of awake thoracic epidural anesthesia (TEA) versus general anesthesia (GA) in patients undergoing thoracotomy. It aims to address the high incidence of chronic postsurgical pain by evaluating the management of acute postoperative pain through these two anesthesia methods. The study will include patients aged 18 to 75 who are classified as ASA II or III and scheduled for thoracotomy, while excluding those with contraindications to TEA or significant health issues. The goal is to determine if TEA can be a viable sole method for anesthesia in major thoracic procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with ASA physical status II or III scheduled for thoracotomy.
Not a fit: Patients with difficult airway management, hemodynamic instability, or contraindications to thoracic epidural anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and reduced incidence of chronic pain after thoracotomy.
How similar studies have performed: While thoracic epidural analgesia has been used as an adjunct to general anesthesia, this study's approach of using it as a sole method for major thoracic procedures is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 75 years old. * Both genders. * American Society of Anesthesiologists (ASA) physical status classification II or III. * Scheduled for thoracotomy. Exclusion Criteria: * Difficult airway management, * Hemodynamically unstable patients, obesity (body mass index \>30). * Absolute contraindication 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: risk of seizure, unable to cooperate, intracranial mass or brain edema, extensive pleural adhesions or previous pulmonary resections, hypoxemia (PaO2 \<60) or hypercarbia (PaCO2 \>50) * Poor cardiac function (ejection fraction less than 50%). * Patients with bad pulmonary function tests.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Mohamed E Abdel Fattah, MD
- Email: mohamed-elsaid@cu.edu.eg
- Phone: 00201284475792
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.