ClinicalTrials.gg
RecruitingNCT05211791Updated May 9, 2023

TEA, ESB and Paravertebral Block During Single-lung Ventilation for Lung Resection

An interventional study of erector spinae block and paravertebral block anesthesia in Lung Diseases and Pain, Acute, sponsored by South Egypt Cancer Institute. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by South Egypt Cancer Institute · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2023, 3 years 5 months ago, but the record still lists the study as recruiting.
  • Started Jan 2022; still recruiting 4 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Lung Diseases with a site in Egypt — 2 open to participants now, 2 under way, 1 of them phase 3. Lung Diseases · Egypt.

Planned enrollment
2nd of 10
90 · median 60
Started
2022
with 2 others
No phase
5 of 13
1 open now
Registered
9th of 13
by date

Among the 13 studies in Lung Diseases with a site in Egypt, this one is the 2nd largest by planned enrollment of the 10 interventional ones that give a count, is one of 3 that started in 2022, is one of 5 with no phase, and was the 9th registered.

Lung Diseases

1,158 studies on the registry are indexed under Lung Diseases; 182 are open to participants now.

Browse Lung Diseases studies →

Open to participants now

2 of the 13 studies in Lung Diseases with a site in Egypt are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 140 Lung Diseases studies recruiting now, 76 (54%) set no upper age limit and 28 (20%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study 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.

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.

03

Conditions studied

  • Lung Diseases
  • Pain, Acute
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • aged between 18 to 70 years old for elective lung resection. with American Society of Anesthesiology physical status (ASA-PS) I-III

Exclusion criteria

Exclusion Criteria:

  • Total pneumonectomy
  • Hepatic or renal dysfunction.
  • for epidural anesthesia as Coagulopathy and neurological and spinal deficits.
  • emergency cases
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Group TEA

    insertion of Thoracic epidural anesthesia plus GA with lung isolation using suitable size double lumen tube at level T6

    Procedure: Thoracic epidural anesthesia

  • Active comparator
    Group ESB

    U/S guided erector spinae block anesthesia using 15 ml local anesthesia plus GA with lung isolation using a suitable size double-lumen tube

    Procedure: erector spinae block

  • Active comparator
    Group PVB

    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

    Procedure: paravertebral block anesthesia

Interventions

  • Procedureerector spinae block

    Ultrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia

  • Procedureparavertebral block anesthesia

    Ultrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia

  • ProcedureThoracic epidural anesthesia

    insertion of Thoracic epidural catheter for anesthesia analgesia at level of T6

06

What researchers measure

Primary outcomes

  1. peri-operative analgesia

    Visual Analogue score (resting and during cough) from 0 (no pain) to 10 (worst pain pain measurement

    Time frame: up to 48 hours postoperative

07

Study locations

1 of 1 sites recruiting
  • South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
    Assiut, 0020, Egypt
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2022 (actual). Primary completion is estimated for Jun 2023, 17 months after the start.

Of 184 non-industry interventional studies with no phase under Lung Diseases, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 47. This study's planned 17 months is below that.

Counting every sponsor, half of 207 studies reached it within 22 months; a quarter within 10 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 2, 2022
First posted
Jan 27, 2022
StartActual
Jan 10, 2022
Primary completionEst.
Jun 10, 2023
CompletionEst.
Oct 20, 2023
Last update
May 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05211791
Lead sponsor
South Egypt Cancer Institute
Responsible party
Alaa Ali M. Elzohry (Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute, Assiut University, Egypt, South Egypt Cancer Institute) — Principal investigator
First posted
Jan 27, 2022
Start date
Jan 10, 2022
Primary completion
Jun 10, 2023 (estimated)
Completion
Oct 20, 2023 (estimated)
Last update
May 9, 2023

Study contacts

Alaa A Elzohry, MD
Contact
alaa.zohiry@hotmail.com
+201007356462
Alaa A Elzohry
principal investigator · Lecturer of Anesthesia , ICU and pain management

Oversight

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

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