Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy

Not Applicable

Recruiting

• Conditions: Awake; Thoracic Epidural Anesthesia; General Anesthesia; Thoracotomy
• Interventions: Drug: Awake thoracic epidural anesthesia; Drug: General anesthesia

• Registration Number: NCT06930183
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2025-03-28
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-15
• Study Start: 2025-04-16
• Study First Posted: 2025-04-16
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Awake thoracic epidural anesthesia group	Awake thoracic epidural anesthesia	Patients will preoperatively receive awake thoracic epidural anesthesia.
General anesthesia group	General anesthesia	Patients will receive general anesthesia.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt