Awake, General Anesthesia, Thoracic Epidural Anesthesia, Thoracotomy
Conditions
Brief summary
This study aims to compare awake thoracic epidural anesthesia and general anesthesia in thoracotomy.
Detailed description
The severity of acute postoperative pain is a causative factor for chronic postsurgical pain, and it has been observed that the incidence of chronic postsurgical pain is very high after thoracotomy. Effective management of acute post-operative pain is a must in these patients. Thoracic epidural analgesia (TEA) is used as an adjunct to general anesthesia (GA) in thoracic surgery. However, tthe horacic epidural blockade has been rarely utilized as a sole method to provide anesthesia for major thoracic procedures
Interventions
DRUGAwake thoracic epidural anesthesia
Patients will preoperatively receive awake thoracic epidural anesthesia.
DRUGGeneral anesthesia
Patients will receive general anesthesia.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment the change in pulmonary function | 24 hours postoperatively | The change in pulmonary function will be assessed using Forced vital capacity (FVC) will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Degree of pain | 48 hours postoperatively | The patients will be instructed how to report pain by means of the visual analogue scale (VAS), in which 0 = no pain and 10 = worst possible pain. VAS will be assessed at post-anesthesia care unit (PACU), 1, 2, 4, 8, 12,18, 24, 36, 48 hours postoperative. |
| 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. |
| Time to 1st rescue analgesia | 48 hours postoperatively | Time to 1st rescue analgesia (time from end of surgery to first dose of morphine administrated). |
| Incidence of adverse events | 48 hours postoperatively | Incidence of adverse events such as nausea, vomiting, and respiratory depression will be recorded. |
| Total morphine consumption | 48 hours postoperatively | Rescue analgesia of morphine will be given as 3 mg bolus if the VAS \> 3 to be repeated after 30 min if pain persists until the visual analogue scale (VAS) \< 4. |
Countries
Egypt
Contacts
Primary ContactMohamed E Abdel Fattah, MD
Outcome results
None listed