Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain

NCT05282251 | Recruiting

• 1 other identifier: Pain managment after VATS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to first rescue analgesia

  The first 24 hours postoperatively

Secondary Outcomes (1)

• Total opioid consumption

  The first 24 hours postoperatively

Study Arms (2)

Intrapleural bupivacine nebulization

EXPERIMENTAL

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

Drug: Intrapleural bupivacine nebulization

Intravenous paracetamol and ketorolac

ACTIVE COMPARATOR

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

Drug: Intravenous paracetamol and ketorolac

Interventions

Intrapleural bupivacine nebulization DRUG

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

Intrapleural bupivacine nebulization

Intravenous paracetamol and ketorolac DRUG

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

Intravenous paracetamol and ketorolac

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients that reach American socity of anesthesiologist class 1-3
• Scheduled for VATS surgery under general anesthesia.

You may not qualify if:

• ● 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Assuit, 880, Egypt

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Esam Moubarak Sahin

CONTACT

01094878158; Emobarak94@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: March 16, 2022
• Study Start: May 17, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

EG (1)