Comparing two anesthesia techniques for awake thoracotomy
Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy: A Randomized Non-inferiority Trial
This study is testing which pain relief method works better for people aged 18 to 60 having awake thoracotomy surgery, comparing a special back injection to another type of nerve block.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06974643 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of thoracic epidural anesthesia and paravertebral block in managing pain during awake thoracotomy procedures. It addresses the high incidence of chronic pain following thoracotomy by evaluating two different anesthesia techniques that target nerve signals responsible for pain. The study will involve patients aged 18 to 60 who are scheduled for thoracotomy and meet specific health criteria. By assessing pain management outcomes, the study seeks to determine which technique provides better relief for patients undergoing this surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 who are scheduled for thoracotomy and have an ASA physical status classification of II or III.
Not a fit: Patients with poor cardiac or pulmonary function, previous thoracotomy, or contraindications to thoracic epidural anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing thoracotomy, potentially reducing the incidence of chronic pain.
How similar studies have performed: Previous studies have shown varying success with similar anesthesia techniques, but this specific comparison is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 60 years. * Both genders. * American Society of Anesthesiologists (ASA) physical status classification II or III. * Scheduled for thoracotomy. Exclusion Criteria: * Poor cardiac function (ejection fraction less than 50%). * Patients with bad pulmonary function testing (PFTs). Absolute contraindication to thoracic epidural anesthesia includes patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at the insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural. * Thoracic spine disorders require chest wall resection or emergency thoracic surgery. * Had a previous thoracotomy (scarring due to prior surgery can limit the effectiveness of paravertebral block, and these patients may have existing chronic pain).
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.