Back to resultsTEA, ESB and Paravertebral Block During Single-lung Ventilation for Lung Resection
Primary Purpose
Lung Diseases, Pain, Acute
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
erector spinae block
paravertebral block anesthesia
Thoracic epidural anesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Lung Diseases
Eligibility Criteria
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:
- Total pneumonectomy
- Hepatic or renal dysfunction.
- contraindications for epidural anesthesia as Coagulopathy and neurological and spinal deficits.
- emergency cases
Sites / Locations
- South Egypt Cancer Institute, Assiut University, Arab Republic of EgyptRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group TEA
Group ESB
Group PVB
Arm Description
insertion of Thoracic epidural anesthesia plus GA with lung isolation using suitable size double lumen tube at level T6
U/S guided erector spinae block anesthesia using 15 ml local anesthesia plus GA with lung isolation using a suitable size double-lumen tube
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
Outcomes
Primary Outcome Measures
peri-operative analgesia
Visual Analogue score (resting and during cough) from 0 (no pain) to 10 (worst pain pain measurement
Secondary Outcome Measures
Full Information
NCT ID
NCT05211791
First Posted
January 2, 2022
Last Updated
May 7, 2023
Sponsor
South Egypt Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT05211791
Brief Title
TEA, ESB and Paravertebral Block During Single-lung Ventilation for Lung Resection
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
June 10, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Pain, Acute
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group TEA
Arm Type
Active Comparator
Arm Description
insertion of Thoracic epidural anesthesia plus GA with lung isolation using suitable size double lumen tube at level T6
Arm Title
Group ESB
Arm Type
Active Comparator
Arm Description
U/S guided erector spinae block anesthesia using 15 ml local anesthesia plus GA with lung isolation using a suitable size double-lumen tube
Arm Title
Group PVB
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
erector spinae block
Intervention Description
Ultrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia
Intervention Type
Procedure
Intervention Name(s)
paravertebral block anesthesia
Intervention Description
Ultrasound-guided insertion of different analgesic procedures as paravertebral block anesthesia and paravertebral block anesthesia
Intervention Type
Procedure
Intervention Name(s)
Thoracic epidural anesthesia
Intervention Description
insertion of Thoracic epidural catheter for anesthesia analgesia at level of T6
Primary Outcome Measure Information:
Title
peri-operative analgesia
Description
Visual Analogue score (resting and during cough) from 0 (no pain) to 10 (worst pain pain measurement
Time Frame
up to 48 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Total pneumonectomy
Hepatic or renal dysfunction.
contraindications for epidural anesthesia as Coagulopathy and neurological and spinal deficits.
emergency cases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa A Elzohry, MD
Phone
+201007356462
Email
alaa.zohiry@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa A Elzohry
Organizational Affiliation
Lecturer of Anesthesia , ICU and pain management
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
City
Assiut
ZIP/Postal Code
0020
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa A. Elzohry, MD
Phone
+2001007356462
Email
alaa.zohiry@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
TEA, ESB and Paravertebral Block During Single-lung Ventilation for Lung Resection
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