Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy

Cairo University (CU)

Status: Enrolling

Conditions: Thoracotomy; Awake; Thoracic Epidural Anesthesia; General Anesthesia

Treatments: Drug: Awake thoracic epidural anesthesia; Drug: General anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06930183

AP2411-501-086-193

Details and patient eligibility

About

This study aims to compare awake thoracic epidural anesthesia and general anesthesia in thoracotomy.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Awake thoracic epidural anesthesia group

Experimental group

Description:

Patients will preoperatively receive awake thoracic epidural anesthesia.

Treatment:

Drug: Awake thoracic epidural anesthesia

General anesthesia group

Active Comparator group

Description:

Patients will receive general anesthesia.

Treatment:

Drug: General anesthesia