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NCT Number: NCT06930183

Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy

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

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Key information

Conditions

Awake General Anesthesia Thoracic Epidural Anesthesia Thoracotomy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Mohamed E Abdel Fattah, MD

CONTACT

[email protected]

00201284475792

Mohammed S ElSharkawy, MD

PRINCIPAL_INVESTIGATOR

Samuel F Samy, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Awake thoracic epidural anesthesia

Drug

Patients will preoperatively receive awake thoracic epidural anesthesia.

Other names: Bupivacaine

General anesthesia

Drug

Patients will receive general anesthesia.

Other names: Fentanyl

Primary outcomes

  1. Assessment the change in pulmonary function

    Time frame: 24 hours postoperatively

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

Secondary outcomes

  1. Heart rate

    Time frame: Till the end of surgery (Up to 2 hours)

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

  2. Mean arterial pressure

    Time frame: 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.

  3. Degree of pain

    Time frame: 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.

  4. Total morphine consumption

    Time frame: 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.

  5. Time to 1st rescue analgesia

    Time frame: 48 hours postoperatively

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

  6. Incidence of adverse events

    Time frame: 48 hours postoperatively

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed E Abdel Fattah, MD

CONTACT

[email protected]

00201284475792

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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