Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain

Not Applicable

Recruiting

• Conditions: Lung Diseases
• Interventions: Drug: Intravenous paracetamol and ketorolac; Drug: Intrapleural bupivacine nebulization

• Registration Number: NCT05282251
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-10
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Status Verified: 2024-05
• Study Start: 2024-05-17
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2024-07-15
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous paracetamol and ketorolac	Intravenous paracetamol and ketorolac	Intravenous analgesia: paracetamol (one gram) and Ketorolac (30 mg) + Intrapleural normal saline (10 ml) as a placebo
Intrapleural bupivacine nebulization	Intrapleural bupivacine nebulization	Intrapleural nebulization of bupivacine (10 ml of bupivacaine 0.5%) + Intravenous normal saline as a placebo

Primary Outcome Measures

Name	Time	Method
Time to first rescue analgesia	The first 24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Total opioid consumption	The first 24 hours postoperatively

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Assuit, Egypt