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Clinical Trials/NCT05282251
NCT05282251
Recruiting
Not Applicable

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

Assiut University1 site in 1 country60 target enrollmentMay 17, 2024

Overview

Phase
Not Applicable
Intervention
Intrapleural bupivacine nebulization
Conditions
Lung Diseases
Sponsor
Assiut University
Enrollment
60
Locations
1
Primary Endpoint
Time to first rescue analgesia
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 17, 2024
End Date
July 15, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Essam El-den Moubark Mohammed Hussein

Resident doctor

Assiut University

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

Arms & Interventions

Intrapleural bupivacine nebulization

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

Intervention: Intrapleural bupivacine nebulization

Intravenous paracetamol and ketorolac

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

Intervention: Intravenous paracetamol and ketorolac

Outcomes

Primary Outcomes

Time to first rescue analgesia

Time Frame: The first 24 hours postoperatively

Secondary Outcomes

  • Total opioid consumption(The first 24 hours postoperatively)

Study Sites (1)

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