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NCT Number: NCT06974643

Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy

This study aims to compare paravertebral block and thoracic epidural in awake thoracotomy.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, 12613, Egypt

Location status: Recruiting

Location contact

Ahmed Mansour, MD

PRINCIPAL_INVESTIGATOR

Mohamed E Abdel Fattah, MD

CONTACT

[email protected]

00201284475792

Mohammed S ElSharkawy, MD

PRINCIPAL_INVESTIGATOR

Samuel F Samy, MD

PRINCIPAL_INVESTIGATOR

About this study

Pain can often persist after thoracotomy, and the incidence of chronic pain is high, with studies revealing that 30% to 50% of patients still experience pain up to five years after surgery.

Thoracic epidural blockade (TEB) blocks nerves that supply the chest with local anesthetic bilaterally, at the spinal cord level. It acts by reducing the onward transmission of painful nerve signals, but may not abolish them altogether. Paravertebral blockade (PVB) involves injecting local anesthetic into the paravertebral space, which contains spinal nerves (and sometimes even extension of the dura), white and grey rami communicantes, the sympathetic chain, and intercostal vessels, on the side of surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 18 to 60 years.
  • Both genders.
  • American Society of Anesthesiologists (ASA) physical status classification II or III.
  • Scheduled for thoracotomy.

Exclusion criteria

  • Poor cardiac function (ejection fraction less than 50%).
  • Patients with bad pulmonary function testing (PFTs). Absolute contraindication to thoracic epidural anesthesia includes patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at the insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural.
  • Thoracic spine disorders require chest wall resection or emergency thoracic surgery.
  • Had a previous thoracotomy (scarring due to prior surgery can limit the effectiveness of paravertebral block, and these patients may have existing chronic pain).

Treatment and study plan

thoracic epidural block

Other

Patients will preoperatively receive an awake thoracic epidural block.

paravertebral block

Other

Patients will preoperatively receive a paravertebral block.

Primary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: Intraoperatively

    Additional bolus doses of fentanyl 0.5µg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.

Secondary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: 48 hours postoperatively

    Time to first request of rescue analgesia will be assessed from the end of surgery till first dose of morphine administrated.

  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. 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

  4. Total morphine consumption

    Time frame: 48 hours postoperatively

    If numeric rating scale (NRS)>3 at rest will be observed, rescue analgesia via IV morphine 3 mg boluses will be administered.

  5. Degree of pain

    Time frame: 48 hours postoperatively

    The patients will be instructed how to report pain by the numeric rating scale (NRS) [on a scale from (0 to 10), zero means no pain and ten means the worst pain]. NRS will be measured at post-anesthesia care unit (PACU), 1, 2, 4, 8, 12, 18, 24, 36, 48 hours postoperatively at rest and movement

  6. Degree of patient satisfaction

    Time frame: 48 hours postoperatively

    Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)

  7. Incidence of adverse events

    Time frame: 48 hours postoperatively

    Incidence of adverse events such as nausea, vomiting, respiratory depression, hypotension and bradycardia

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

Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy: A Randomized Non-inferiority Trial

Important dates

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