ClinicalTrials.gg
Status unknownNCT05282251Updated May 20, 2024

Intrapleural Nebulization of Bupivacain to Reduce Postoperative Pain

An interventional study of Intrapleural bupivacine nebulization and Intravenous paracetamol and ketorolac in Lung Diseases, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-05-20.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Lung Diseases

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03

In context

Lung Diseases

3,319 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's planned enrollment of 60 is below the median of 71 across 2,122 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients that reach American socity of anesthesiologist class 1-3
  • Scheduled for VATS surgery under general anesthesia.

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Intrapleural bupivacine nebulization

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

    Drug: Intrapleural bupivacine nebulization

  • Active comparator
    Intravenous paracetamol and ketorolac

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

    Drug: Intravenous paracetamol and ketorolac

Interventions

  • DrugIntrapleural bupivacine nebulization

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

  • DrugIntravenous paracetamol and ketorolac

    Drug pages: Acetaminophen · Ketorolac

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

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What researchers measure

Primary outcomes

  1. Time to first rescue analgesia

    Time frame: The first 24 hours postoperatively

Secondary outcomes

  1. Total opioid consumption

    Time frame: The first 24 hours postoperatively

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Study locations

1 of 1 sites recruiting
  • Assiut University
    Asyut, Assuit 880, Egypt
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05282251
Lead sponsor
Assiut University
Responsible party
Essam El-den Moubark Mohammed Hussein (Resident doctor, Assiut University) — Principal investigator
First posted
Mar 16, 2022
Start date
May 17, 2024
Primary completion
Jul 15, 2024 (estimated)
Completion
Jul 15, 2024 (estimated)
Last update
May 20, 2024

Study contacts

Esam Moubarak Sahin
Contact
Emobarak94@gmail.com
01094878158 ext. 01551434651

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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