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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

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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.

02

Conditions studied

  • Lung Diseases
  • Pain, Acute

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03

Who can participate

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

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.
  • contraindications for epidural anesthesia as Coagulopathy and neurological and spinal deficits.
  • emergency cases
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
    Assiut, 0020, Egypt
    Recruiting
07

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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