Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain

NCT ID: NCT05282251

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2024-07-15

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.

Conditions

Lung Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intrapleural bupivacine nebulization

Intrapleural nebulization of bupivacine (10 ml of bupivacaine 0.5%) + Intravenous normal saline as a placebo

Group Type: EXPERIMENTAL

Intrapleural bupivacine nebulization

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Intravenous paracetamol and ketorolac

Intervention Type: DRUG

Intravenous analgesia: paracetamol (one gram) and Ketorolac (30 mg) + Intrapleural normal saline (10 ml) as a placebo

Interventions

Intrapleural bupivacine nebulization

Intrapleural nebulization of bupivacine (10 ml of bupivacaine 0.5%) + Intravenous normal saline as a placebo

Intervention Type: DRUG

Intravenous paracetamol and ketorolac

Intravenous analgesia: paracetamol (one gram) and Ketorolac (30 mg) + Intrapleural normal saline (10 ml) as a placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Essam El-den Moubark Mohammed Hussein

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University

Asyut, Assuit, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Esam Moubarak Sahin

Role: CONTACT

Emobarak94@gmail.com

01094878158 ext. 01551434651

Facility Contacts

Assuit Assuit University, Bachelor

Role: primary

Emobarak94@gmail.com

01094878158 ext. 01551434651

Other Identifiers

Pain managment after VATS

Identifier Type: -

Identifier Source: org_study_id