Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain
Primary Purpose
Lung Diseases
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacain
Sponsored by
About this trial
This is an interventional prevention trial for Lung Diseases
Eligibility Criteria
Inclusion Criteria:
- age: > 18 years
- Patients that reach American socity of anesthesiologist class 1-111
- Scheduled for VATS surgery under general anesthesia.
Exclusion Criteria:
● Allergy to local anesthetics
- Patient with pleural inflammation due to recent pneumonia
- Patients who are unable or unwilling to perform spirometer test
- Renal dysfunction: (Elevated creatinine > 2 mg\dl)
- Hepatic dysfunction: (Elevated hepatic enzymes three times above normal value)
- History of addiction
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pain managment after VATS
Arm Description
Outcomes
Primary Outcome Measures
Numeric pain scale
Decrease pain assessed by Numeric pain scal
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05282251
Brief Title
Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain
Official Title
Pain Managment After VATS to Reduce Postoperative Pain and Improve Pulmonary Function
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Thoracic surgery is now common and as other surgeries evolution of minimally invasive techniques is employed. Video-assisted thoracic surgery (VATS) produces little scar but may produce severe pain that may affect the pulmonary function. Many procedure was developed like intercostal nerve block which require injections at multiple levels, Insertion of local anaesthetic (LA) in the surgical drain but that was dangerous due to the large amount of LA and not sufficient to completely eliminate pain. Bupvicaine nebulization, through surgical port which won't make any other wound, thought to be sufficient because Nebulization will enable us better distribution and less amounts of LA. Bupvicaine is local anaesthetic amide group that works by blocking sodium channels thus preventing progression of action potential.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pain managment after VATS
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bupivacain
Intervention Description
Intrapleural Nebulization of local anaesthetic
Primary Outcome Measure Information:
Title
Numeric pain scale
Description
Decrease pain assessed by Numeric pain scal
Time Frame
24 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age: > 18 years
Patients that reach American socity of anesthesiologist class 1-111
Scheduled for VATS surgery under general anesthesia.
Exclusion Criteria:
● Allergy to local anesthetics
Patient with pleural inflammation due to recent pneumonia
Patients who are unable or unwilling to perform spirometer test
Renal dysfunction: (Elevated creatinine > 2 mg\dl)
Hepatic dysfunction: (Elevated hepatic enzymes three times above normal value)
History of addiction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esam Moubarak Sahin
Phone
01094878158
Ext
01551434651
Email
Emobarak94@gmail.com
Facility Information:
Facility Name
Assiut University
City
Assiut
State/Province
Assuit
ZIP/Postal Code
880
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assuit Assuit University, Bachelor
Phone
01094878158
Ext
01551434651
Email
Emobarak94@gmail.com
12. IPD Sharing Statement
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Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain
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