Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain

Assiut University

Status: Enrolling

Conditions: Lung Diseases

Treatments: Drug: Intravenous paracetamol and ketorolac; Drug: Intrapleural bupivacine nebulization

Study type: Interventional

Funder types: Other

Identifiers

NCT05282251

Pain managment after VATS

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

Intrapleural bupivacine nebulization

Experimental group

Description:

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

Treatment:

Drug: Intrapleural bupivacine nebulization

Intravenous paracetamol and ketorolac

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous paracetamol and ketorolac