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RecruitingNCT06974643Updated May 16, 2025

Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy

An interventional study of Thoracic epidural block and Paravertebral block in Thoracic Epidural Anesthesia, Paravertebral Block and Awake Thoracotomy, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed description

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.

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Conditions studied

  • Thoracic Epidural Anesthesia
  • Paravertebral Block
  • Awake Thoracotomy

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03

In context

Aortic Dissection

386 studies on the registry are indexed under Aortic Dissection; 117 are open to participants now.

This study's planned enrollment of 60 is below the median of 84 across 198 interventional studies indexed under Aortic Dissection.

Browse Aortic Dissection studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Thoracic epidural block group

    Patients will preoperatively receive an awake thoracic epidural block.

    Other: Thoracic epidural block

  • Experimental
    Paravertebral block group

    Patients will preoperatively receive a paravertebral block.

    Other: Paravertebral block

Interventions

  • OtherThoracic epidural block

    Patients will preoperatively receive an awake thoracic epidural block.

  • OtherParavertebral block

    Patients will preoperatively receive a paravertebral block.

06

What researchers measure

Primary outcomes

  1. Intraoperative fentanyl consumption

    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.

    Time frame: Intraoperatively

Secondary outcomes

  1. Time to the 1st rescue analgesia

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

    Time frame: 48 hours postoperatively

  2. 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)

  3. 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)

  4. Total morphine consumption

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

    Time frame: 48 hours postoperatively

  5. Degree of pain

    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

    Time frame: 48 hours postoperatively

  6. Degree of patient satisfaction

    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)

    Time frame: 48 hours postoperatively

  7. Incidence of adverse events

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

    Time frame: 48 hours postoperatively

07

Study locations

1 of 1 sites recruiting
  • Cairo University
    Cairo, 12613, Egypt
    • Mohamed E Abdel Fattah, MD · Contact · mohamed-elsaid@cu.edu.eg · 00201284475792
    • Samuel F Samy, MD · Principal investigator
    • Ahmed Mansour, MD · Principal investigator
    • Mohammed S ElSharkawy, MD · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06974643
Lead sponsor
Cairo University
Responsible party
Mohamed Elsaid Abdel Fattah (Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt., Cairo University) — Principal investigator
First posted
May 16, 2025
Start date
May 15, 2025
Primary completion
Oct 1, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
May 16, 2025

Study contacts

Mohamed E Abdel Fattah, MD
Contact
mohamed-elsaid@cu.edu.eg
00201284475792

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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