Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain

Lung Diseases Clinical Trial

Official title:

Pain Managment After VATS to Reduce Postoperative Pain and Improve Pulmonary Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05282251
• Other study ID #: Pain managment after VATS
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2024
• Est. completion date: July 15, 2024

Study information

• Verified date: May 2024
• Source: Assiut University
• Contact: Esam Moubarak Sahin
• Phone: 01094878158
• Email: Emobarak94[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients that reach American socity of anesthesiologist class 1-3

• 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

Related Conditions & MeSH terms

• Lung Diseases
• Pain, Postoperative

Intervention

Drug:
• Intrapleural bupivacine nebulization
Intrapleural nebulization of bupivacine (10 ml of bupivacaine 0.5%) + Intravenous normal saline as a placebo
• Intravenous paracetamol and ketorolac
Intravenous analgesia: paracetamol (one gram) and Ketorolac (30 mg) + Intrapleural normal saline (10 ml) as a placebo

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first rescue analgesia		The first 24 hours postoperatively
Secondary	Total opioid consumption		The first 24 hours postoperatively