Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05282251

Enrollment

Registered

2022-03-16

Start date

2024-05-17

Completion date

2024-07-15

Last updated

2024-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

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.

Interventions

DRUGIntrapleural bupivacine nebulization

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

DRUGIntravenous paracetamol and ketorolac

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Time to first rescue analgesia	The first 24 hours postoperatively

Secondary

Measure	Time frame
Total opioid consumption	The first 24 hours postoperatively

Countries

Egypt

Contacts

Primary ContactEsam Moubarak Sahin

Emobarak94@gmail.com01094878158

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026