Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy
- Conditions
- Thoracic Epidural AnesthesiaParavertebral BlockAwake Thoracotomy
- Registration Number
- NCT06974643
- Lead Sponsor
- Cairo University
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Age from 18 to 60 years.
- Both genders.
- American Society of Anesthesiologists (ASA) physical status classification II or III.
- Scheduled for thoracotomy.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Intraoperative fentanyl consumption Intraoperatively Additional bolus doses of fentanyl 0.5µg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
- Secondary Outcome Measures
Name Time Method Time to the 1st rescue analgesia 48 hours postoperatively Time to first request of rescue analgesia will be assessed from the end of surgery till first dose of morphine administrated.
Mean arterial pressure Till the end of surgery (Up to 2 hours) Mean arterial pressure will be recorded at baseline, and every 15min till the end of surgery
Heart rate Till the end of surgery (Up to 2 hours) Heart rate will be recorded at baseline, and every 15min till the end of surgery
Total morphine consumption 48 hours postoperatively If numeric rating scale (NRS)\>3 at rest will be observed, rescue analgesia via IV morphine 3 mg boluses will be administered.
Degree of pain 48 hours postoperatively The patients will be instructed how to report pain by the numeric rating scale (NRS) \[on a scale from (0 to 10), zero means no pain and ten means the worst pain\]. NRS will be measured at post-anesthesia care unit (PACU), 1, 2, 4, 8, 12, 18, 24, 36, 48 hours postoperatively at rest and movement
Degree of patient satisfaction 48 hours postoperatively Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Incidence of adverse events 48 hours postoperatively Incidence of adverse events such as nausea, vomiting, respiratory depression, hypotension and bradycardia
Trial Locations
- Locations (1)
Cairo University
🇪🇬Cairo, Egypt