Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases
• Intervention / Treatment: Drug: Intrapleural bupivacine nebulization; Drug: Intravenous paracetamol and ketorolac

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esam Moubarak Sahin; Phone Number: 01551434651 01094878158; Email: Emobarak94@gmail.com

Study Locations

• Egypt
  • Assuit
    • Assiut, Assuit, Egypt, 880
      • Recruiting
      • Assiut University
      • Contact: Assuit Assuit University, Bachelor; Phone Number: 01551434651 01094878158; Email: Emobarak94@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrapleural bupivacine nebulization; Intrapleural nebulization of bupivacine (10 ml of bupivacaine 0.5%) + Intravenous normal saline as a placebo	Drug: Intrapleural bupivacine nebulization; Intrapleural nebulization of bupivacine (10 ml of bupivacaine 0.5%) + Intravenous normal saline as a placebo
Active Comparator: Intravenous paracetamol and ketorolac; Intravenous analgesia: paracetamol (one gram) and Ketorolac (30 mg) + Intrapleural normal saline (10 ml) as a placebo	Drug: Intravenous paracetamol and ketorolac; Intravenous analgesia: paracetamol (one gram) and Ketorolac (30 mg) + Intrapleural normal saline (10 ml) as a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first rescue analgesia	The first 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Total opioid consumption	The first 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): July 15, 2024

Study Registration Dates

• First Submitted: October 10, 2021
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Lung Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Ketorolac; Acetaminophen
• Other Study ID Numbers: Pain managment after VATS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No