Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy

Cairo University50 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Awake Thoracic Epidural Anesthesia General Anesthesia Thoracotomy

Interventions

Awake thoracic epidural anesthesiaDRUG

Patients will preoperatively receive awake thoracic epidural anesthesia.

General anesthesiaDRUG

Patients will receive general anesthesia.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cairo University

Cairo, Egypt

RECRUITING

Outcomes

Primary Outcomes

Assessment the change in pulmonary function

The change in pulmonary function will be assessed using Forced vital capacity (FVC) will be recorded.

Time frame: 24 hours postoperatively

Secondary Outcomes

Heart rate

Heart rate will be recorded at baseline, and every 15min till the end of surgery.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 48 hours postoperatively

Time to 1st rescue analgesia

Time to 1st rescue analgesia (time from end of surgery to first dose of morphine administrated).

Time frame: 48 hours postoperatively

Incidence of adverse events

Incidence of adverse events such as nausea, vomiting, and respiratory depression will be recorded.

Central Contacts

Mohamed E Abdel Fattah, MD

CONTACT

00201284475792 mohamed-elsaid@cu.edu.eg

Data from ClinicalTrials.gov

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