Lung DiseasesNCT05211791
TEA, ESB and Paravertebral Block During Single-lung Ventilation for Lung Resection
A study testing erector spinae block, paravertebral block anesthesia and Thoracic epidural anesthesia in people with Lung Diseases and Pain, Acute, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
Thoracotomy operations are known to be painful surgical procedures, so providing effective intraoperative and postoperative analgesia is so important for all anaesthesiologists. Ineffective pain management interferes with deep breathing, coughing, and remobilization resulting in atelectasis and pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Diseases, Pain, Acute
- What is being tested?
- erector spinae block, paravertebral block anesthesia and Thoracic epidural anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2022to 20 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 to 70 years old for elective lung resection. with American Society of Anesthesiology physical status (ASA-PS) I-III
Who cannot join
- Total pneumonectomy
- Hepatic or renal dysfunction.
- contraindications for epidural anesthesia as Coagulopathy and neurological and spinal deficits.
- emergency cases
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Asyut, 0020
Alaa A. Elzohry, MD, +2001007356462, alaa.zohiry@hotmail.com
About this study
Official title: Comparison Between Thoracic Epidural Anaesthesia, Erector Spinae Block and Paravertebral Block During Single-lung Ventilation for Lung Resection in Lateral Decubitus Position: A Prospective Randomized Study
Thoracotomy operations are known to be painful surgical procedures, so providing effective intraoperative and postoperative analgesia is so important for all anaesthesiologists. Ineffective pain management interferes with deep breathing, coughing, and remobilization resulting in atelectasis and pneumonia.
Ultrasound-guided ESP block is a myofascial plane block that provides analgesia for thoracic or abdominal segmental innervation depending on the level of the injection site. Thoracic epidural analgesia (TEA) is considered the gold standard analgesic technique for thoracic surgeries. But the invasiveness of this technique, the rare but serious neurologic complications and the failure rates up to 30% are the disadvantages of epidural analgesia
Read the detailed description
The aim of this study is to compare the effect of different blocks as TEA, erector spinae block or paravertebral block on improving peri-operative analgesia and post-operative outcome in pulmonary resection in adult patients.
- Conditions
- Lung Diseases, Pain, Acute
- Being tested
- erector spinae block, paravertebral block anesthesia, Thoracic epidural anesthesia
- Medical subject headings
- Lung Diseases, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae blockProcedure or surgery
Ultrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia
paravertebral block anesthesiaProcedure or surgery
Ultrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia
Thoracic epidural anesthesiaProcedure or surgery
insertion of Thoracic epidural catheter for anesthesia analgesia at level of T6
| Study group | Role | What they receive |
|---|---|---|
| Group TEA | Active comparator | insertion of Thoracic epidural anesthesia plus GA with lung isolation using suitable size double lumen tube at level T6 Receives: Procedure: Thoracic epidural anesthesia |
| Group ESB | Active comparator | U/S guided erector spinae block anesthesia using 15 ml local anesthesia plus GA with lung isolation using a suitable size double-lumen tube Receives: Procedure: erector spinae block |
| Group PVB | Active comparator | U/S guided paravertebral block anesthesia using 15 ml local anesthesia as total volume plus GA with lung isolation using suitable size double lumen tube Receives: Procedure: paravertebral block anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-operative analgesia
Visual Analogue score (resting and during cough) from 0 (no pain) to 10 (worst pain pain measurement
Measured: up to 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start10 Jan 2022
- Primary completion10 Jun 2023 (estimated)
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ali M. Elzohry, South Egypt Cancer Institute
- Investigators
- Alaa A Elzohry, Principal investigator, Lecturer of Anesthesia , ICU and pain management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211791
- Sponsor's protocol ID
- TEA in single lung ventilation
- Status last verified
- May 2023
- First submitted
- 2 Jan 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Thoracic Epidural Anaesthesia, Erector Spinae Block and Paravertebral Block During Single-lung Ventilation for Lung Resection in Lateral Decubitus Position: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05211791
- Acronym / sponsor ID
- TEA in single lung ventilation
- Conditions
- Lung Diseases, Pain, Acute
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 27 Jan 2022 (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.
Thoracotomy operations are known to be painful surgical procedures, so providing effective intraoperative and postoperative analgesia is so important for all anaesthesiologists. Ineffective pain management interferes with deep breathing, coughing, and remobilization resulting in atelectasis and pneumonia.
Ultrasound-guided ESP block is a myofascial plane block that provides analgesia for thoracic or abdominal segmental innervation depending on the level of the injection site. Thoracic epidural analgesia (TEA) is considered the gold standard analgesic technique for thoracic surgeries. But the invasiveness of this technique, the rare but serious neurologic complications and the failure rates up to 30% are the disadvantages of epidural analgesia
Detailed description
The aim of this study is to compare the effect of different blocks as TEA, erector spinae block or paravertebral block on improving peri-operative analgesia and post-operative outcome in pulmonary resection in adult patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group TEA | Active comparator | Procedure: Thoracic epidural anesthesiainsertion of Thoracic epidural anesthesia plus GA with lung isolation using suitable size double lumen tube at level T6 |
| Group ESB | Active comparator | Procedure: erector spinae blockU/S guided erector spinae block anesthesia using 15 ml local anesthesia plus GA with lung isolation using a suitable size double-lumen tube |
| Group PVB | Active comparator | Procedure: paravertebral block anesthesiaU/S guided paravertebral block anesthesia using 15 ml local anesthesia as total volume plus GA with lung isolation using suitable size double lumen tube |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged between 18 to 70 years old for elective lung resection. with American Society of Anesthesiology physical status (ASA-PS) I-III
Key exclusion criteria (4 listed)
- Total pneumonectomy
- Hepatic or renal dysfunction.
- contraindications for epidural anesthesia as Coagulopathy and neurological and spinal deficits.
- emergency cases
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 |
|---|---|---|
| erector spinae blockUltrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia | Procedure or surgery | Group ESB |
| paravertebral block anesthesiaUltrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia | Procedure or surgery | Group PVB |
| Thoracic epidural anesthesiainsertion of Thoracic epidural catheter for anesthesia analgesia at level of T6 | Procedure or surgery | Group TEA |
Primary outcome
peri-operative analgesia
Time frame: up to 48 hours postoperative
Visual Analogue score (resting and during cough) from 0 (no pain) to 10 (worst pain pain measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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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. This study is not recruiting at the moment.
Alaa A Elzohry principal investigator
Lecturer of Anesthesia , ICU and pain management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinae block, paravertebral block anesthesia and Thoracic epidural anesthesia in people with Lung Diseases and Pain, Acute, run by South Egypt Cancer Institute 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 1 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: status not confirmed, as of the sponsor's last update on 9 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa A Elzohry, MD (+201007356462, alaa.zohiry@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
peri-operative analgesia (time frame: up to 48 hours postoperative). 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 9 May 2023.