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: Not yet recruiting
• Conditions: Lung Diseases
• Intervention / Treatment: Drug: Bupivacain

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Early Phase 1

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

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pain managment after VATS	Drug: Bupivacain; Intrapleural Nebulization of local anaesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric pain scale	Decrease pain assessed by Numeric pain scal	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

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): March 16, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

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; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• 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