Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy

Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy: A Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Thoracotomy; General Anesthesia; Thoracic Epidural Anesthesia; Awake
• Intervention / Treatment: Drug: General anesthesia; Drug: Awake thoracic epidural anesthesia

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed E Abdel Fattah, MD; Phone Number: 00201284475792; Email: mohamed-elsaid@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Recruiting
    • Cairo University
    • Principal Investigator: Mohammed S ElSharkawy, MD
    • Contact: Mohamed E Abdel Fattah, MD; Phone Number: 00201284475792; Email: mohamed-elsaid@cu.edu.eg
    • Principal Investigator: Samuel F Samy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Awake thoracic epidural anesthesia group; Patients will preoperatively receive awake thoracic epidural anesthesia.	Drug: Awake thoracic epidural anesthesia; Patients will preoperatively receive awake thoracic epidural anesthesia.; Other Names: Bupivacaine
Active Comparator: General anesthesia group; Patients will receive general anesthesia.	Drug: General anesthesia; Patients will receive general anesthesia.; Other Names: Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment the change in pulmonary function	The change in pulmonary function will be assessed using Forced vital capacity (FVC) will be recorded.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Heart rate will be recorded at baseline, and every 15min till the end of surgery.	Till the end of surgery (Up to 2 hours)
Mean arterial pressure	Mean arterial pressure will be recorded at baseline, and every 15min till the end of surgery.	Till the end of surgery (Up to 2 hours)
Degree of pain	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.	48 hours postoperatively
Total morphine consumption	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.	48 hours postoperatively
Time to 1st rescue analgesia	Time to 1st rescue analgesia (time from end of surgery to first dose of morphine administrated).	48 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as nausea, vomiting, and respiratory depression will be recorded.	48 hours postoperatively

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dissection, Blood Vessel; Acute Aortic Syndrome; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Dissection; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Bupivacaine; Anesthetics; Fentanyl
• Other Study ID Numbers: AP2411-501-086-193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No