Thoracic Epidural AnesthesiaNCT06974643
Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy
A study testing Thoracic epidural block and Paravertebral block in people with Thoracic Epidural Anesthesia and Paravertebral Block, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare paravertebral block and thoracic epidural in awake thoracotomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thoracic Epidural Anesthesia, Paravertebral Block, Awake Thoracotomy
- What is being tested?
- Thoracic epidural block and Paravertebral block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 18 to 60 years.
- Both genders.
- American Society of Anesthesiologists (ASA) physical status classification II or III.
- Scheduled for thoracotomy.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Mohamed E Abdel Fattah, MD, 00201284475792, mohamed-elsaid@cu.edu.eg
Samuel F Samy, MD
About this study
Official title: Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy: A Randomized Non-inferiority Trial
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.
- Being tested
- Thoracic epidural block, Paravertebral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural blockOther
Patients will preoperatively receive an awake thoracic epidural block.
Paravertebral blockOther
Patients will preoperatively receive a paravertebral block.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural block group | Experimental | Patients will preoperatively receive an awake thoracic epidural block. Receives: Other: Thoracic epidural block |
| Paravertebral block group | Experimental | Patients will preoperatively receive a paravertebral block. Receives: Other: Paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperatively
Secondary outcomes (7)
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.
Measured: 48 hours postoperatively
Mean arterial pressure
Mean arterial pressure will be recorded at baseline, and every 15min till the end of surgery
Measured: Till the end of surgery (Up to 2 hours)
Heart rate
Heart rate will be recorded at baseline, and every 15min till the end of surgery
Measured: Till the end of surgery (Up to 2 hours)
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.
Measured: 48 hours postoperatively
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
Measured: 48 hours postoperatively
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)
Measured: 48 hours postoperatively
Incidence of adverse events
Incidence of adverse events such as nausea, vomiting, respiratory depression, hypotension and bradycardia
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start15 May 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Epidural AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsaid Abdel Fattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974643
- Sponsor's protocol ID
- AP2503-501-099-197
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Epidural Anesthesia Versus Paravertebral Block for Awake Thoracotomy: A Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06974643
- Acronym / sponsor ID
- AP2503-501-099-197
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare paravertebral block and thoracic epidural in awake thoracotomy.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural block group | Experimental | Other: Thoracic epidural blockPatients will preoperatively receive an awake thoracic epidural block. |
| Paravertebral block group | Experimental | Other: Paravertebral blockPatients will preoperatively receive a paravertebral block. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 18 to 60 years.
- Both genders.
- American Society of Anesthesiologists (ASA) physical status classification II or III.
- Scheduled for thoracotomy.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic epidural blockPatients will preoperatively receive an awake thoracic epidural block. | Other | Thoracic epidural block group |
| Paravertebral blockPatients will preoperatively receive a paravertebral block. | Other | Paravertebral block group |
Primary outcome
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.
7 secondary outcomes
Time to the 1st rescue analgesia
Time frame: 48 hours postoperatively
Mean arterial pressure
Time frame: Till the end of surgery (Up to 2 hours)
Heart rate
Time frame: Till the end of surgery (Up to 2 hours)
Total morphine consumption
Time frame: 48 hours postoperatively
Degree of pain
Time frame: 48 hours postoperatively
Degree of patient satisfaction
Time frame: 48 hours postoperatively
Incidence of adverse events
Time frame: 48 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic epidural block and Paravertebral block in people with Thoracic Epidural Anesthesia and Paravertebral Block, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Abdel Fattah, MD (00201284475792, mohamed-elsaid@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative fentanyl consumption (time frame: Intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.