Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy

NCT ID: NCT06930183

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-16

Study Completion Date

2025-10-01

Brief Summary

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

Detailed Description

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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

Conditions

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Awake Thoracic Epidural Anesthesia General Anesthesia Thoracotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Awake thoracic epidural anesthesia group

Patients will preoperatively receive awake thoracic epidural anesthesia.

Group Type EXPERIMENTAL

Awake thoracic epidural anesthesia

Intervention Type DRUG

Patients will preoperatively receive awake thoracic epidural anesthesia.

General anesthesia group

Patients will receive general anesthesia.

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type DRUG

Patients will receive general anesthesia.

Interventions

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Awake thoracic epidural anesthesia

Patients will preoperatively receive awake thoracic epidural anesthesia.

Intervention Type DRUG

General anesthesia

Patients will receive general anesthesia.

Intervention Type DRUG

Other Intervention Names

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Bupivacaine Fentanyl

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Elsaid Abdel Fattah

Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed E Abdel Fattah, MD

Role: CONTACT

00201284475792

Facility Contacts

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Mohamed E Abdel Fattah, MD

Role: primary

00201284475792

Other Identifiers

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AP2411-501-086-193

Identifier Type: -

Identifier Source: org_study_id

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