Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Thoracic epidural block, Paravertebral block.
- Who it may be relevant to
- Registry conditions: Thoracic Epidural Anesthesia, Paravertebral Block, Awake Thoracotomy. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy: A Randomized Non-inferiority Trial
Overview
This study aims to compare paravertebral block and thoracic epidural in awake thoracotomy.
Detailed description
Pain can often persist after thoracotomy, and the incidence of chronic pain is high, with studies revealing that 30% to 50% of patients still experience pain up to five years after surgery.
Thoracic epidural blockade (TEB) blocks nerves that supply the chest with local anesthetic bilaterally, at the spinal cord level. It acts by reducing the onward transmission of painful nerve signals, but may not abolish them altogether. Paravertebral blockade (PVB) involves injecting local anesthetic into the paravertebral space, which contains spinal nerves (and sometimes even extension of the dura), white and grey rami communicantes, the sympathetic chain, and intercostal vessels, on the side of surgery.
Interventions
- Other Thoracic epidural block
Patients will preoperatively receive an awake thoracic epidural block. - Other Paravertebral block
Patients will preoperatively receive a paravertebral block.
Primary outcome measures
- Intraoperative fentanyl consumption [Time frame: Intraoperatively]
Secondary outcome measures (7)
- Time to the 1st rescue analgesia [Time frame: 48 hours postoperatively]
- Mean arterial pressure [Time frame: Till the end of surgery (Up to 2 hours)]
- Heart rate [Time frame: Till the end of surgery (Up to 2 hours)]
- Total morphine consumption [Time frame: 48 hours postoperatively]
- Degree of pain [Time frame: 48 hours postoperatively]
- Degree of patient satisfaction [Time frame: 48 hours postoperatively]
- Incidence of adverse events [Time frame: 48 hours postoperatively]
Eligibility 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT06974643 · AP2503-501-099-197