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Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures

Primary Purpose

Pleural Neoplasms, Aspiration, Respiratory, Pleural Effusion

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Diclofenac
Placebo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pleural Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients of both genders.
  • Patients with pleural effusion, pneumothorax, lung mass or chest wall mass accessible for thoracic ultrasound guided intervention

Exclusion Criteria:

  • Children and patients less than 18 years old.
  • Pregnant and lactating ladies.
  • Patients with disturbed level of consciousness.
  • Patients with known bleeding disorders.
  • Patients with advanced liver and kidney disorders.
  • Patients with known hypersensitivity to NSAIDS.
  • Patients with chronic chest diseases.
  • Patients who refuse to participate in the trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Diclofenac

    Placebo

    Arm Description

    Group A will receive a single dose 75 mg IV diclofenac by infusion prior to the procedure

    Group B who will receive placebo

    Outcomes

    Primary Outcome Measures

    Pain intensity assessed by Numerical Rating Scale (NRS)
    evaluate the efficacy of single dose analgesia in combination with local anaesthesia to control pain during TUS guided procedures by Numerical Rating Scale , patient is asked to indicate his/her perceived pain intensity , the patient grades their own pain on a scale between 1 to 10
    Satisfaction assessed by the Visual Analogue Scale (VAS)
    satisfaction assessment by Visual Analogue Scale , series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
    performance time of transthoracic ultrasound guided procedures
    assess the effect of its use with local anaesthesia on procedure performance compared to local anaesthesia alone

    Secondary Outcome Measures

    Full Information

    First Posted
    September 25, 2021
    Last Updated
    November 4, 2021
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05121233
    Brief Title
    Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures
    Official Title
    Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2021 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    October 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes

    5. Study Description

    Brief Summary
    This study aims to evaluate the efficacy of single dose analgesia in combination with local anesthesia to control pain during Trans Ultrasound guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anesthesia alone.
    Detailed Description
    Interventional thoracic ultrasonography (TUS) includes both diagnostic and therapeutic procedures. Fine-needle aspiration biopsy , Tru-cut Pleural or lung parenchymal biopsy and Cope or Abrams needles pleural biopsies are examples of diagnostic procedures while ultrasound guided thoracentesis, pleural aspiration for pneumothorax, placement of chest tubes, and indwelling catheter insertion, or pleurodesis are common therapeutic procedures. Thoracic ultrasound guided procedures are safe and tolerable. Pain, pneumothorax, bleeding, infection, and procedure failure are the possible complications of TUS guided procedures. Lidocaine 1% should be infiltrated prior to the procedure, paying particular attention to the skin, periosteum and the pleura as a local anesthesia. To reduce pain, analgesia should be considered as premedication. Despite the apparent common sense of this approach, there is little established evidence of the effect from these medications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pleural Neoplasms, Aspiration, Respiratory, Pleural Effusion, Lung Neoplasms, Pneumothorax, Pyothorax

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Diclofenac
    Arm Type
    Active Comparator
    Arm Description
    Group A will receive a single dose 75 mg IV diclofenac by infusion prior to the procedure
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Group B who will receive placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Diclofenac
    Intervention Description
    a single dose 75 mg IV diclofenac by infusion prior to the procedure
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    single dose iv placebo (saline ) by infusion prior to the procedure
    Primary Outcome Measure Information:
    Title
    Pain intensity assessed by Numerical Rating Scale (NRS)
    Description
    evaluate the efficacy of single dose analgesia in combination with local anaesthesia to control pain during TUS guided procedures by Numerical Rating Scale , patient is asked to indicate his/her perceived pain intensity , the patient grades their own pain on a scale between 1 to 10
    Time Frame
    30 minutes
    Title
    Satisfaction assessed by the Visual Analogue Scale (VAS)
    Description
    satisfaction assessment by Visual Analogue Scale , series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable"
    Time Frame
    30 minutes
    Title
    performance time of transthoracic ultrasound guided procedures
    Description
    assess the effect of its use with local anaesthesia on procedure performance compared to local anaesthesia alone
    Time Frame
    up to 20 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients of both genders. Patients with pleural effusion, pneumothorax, lung mass or chest wall mass accessible for thoracic ultrasound guided intervention Exclusion Criteria: Children and patients less than 18 years old. Pregnant and lactating ladies. Patients with disturbed level of consciousness. Patients with known bleeding disorders. Patients with advanced liver and kidney disorders. Patients with known hypersensitivity to NSAIDS. Patients with chronic chest diseases. Patients who refuse to participate in the trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mostafa mahmoud ahmed
    Phone
    0201001554241
    Email
    doc.mostafa5454@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23396954
    Citation
    Almolla J, Balconi G. Interventional ultrasonography of the chest: Techniques and indications. J Ultrasound. 2011 Mar;14(1):28-36. doi: 10.1016/j.jus.2011.01.005. Epub 2011 Feb 12.
    Results Reference
    background
    PubMed Identifier
    20696688
    Citation
    Havelock T, Teoh R, Laws D, Gleeson F; BTS Pleural Disease Guideline Group. Pleural procedures and thoracic ultrasound: British Thoracic Society Pleural Disease Guideline 2010. Thorax. 2010 Aug;65 Suppl 2:ii61-76. doi: 10.1136/thx.2010.137026. No abstract available.
    Results Reference
    background
    PubMed Identifier
    26720026
    Citation
    Rahman NM, Pepperell J, Rehal S, Saba T, Tang A, Ali N, West A, Hettiarachchi G, Mukherjee D, Samuel J, Bentley A, Dowson L, Miles J, Ryan CF, Yoneda KY, Chauhan A, Corcoran JP, Psallidas I, Wrightson JM, Hallifax R, Davies HE, Lee YC, Dobson M, Hedley EL, Seaton D, Russell N, Chapman M, McFadyen BM, Shaw RA, Davies RJ, Maskell NA, Nunn AJ, Miller RF. Effect of Opioids vs NSAIDs and Larger vs Smaller Chest Tube Size on Pain Control and Pleurodesis Efficacy Among Patients With Malignant Pleural Effusion: The TIME1 Randomized Clinical Trial. JAMA. 2015 Dec 22-29;314(24):2641-53. doi: 10.1001/jama.2015.16840. Erratum In: JAMA. 2016 Feb 16;315(7):707. JAMA. 2016 Apr 19;315(15):1661.
    Results Reference
    background
    PubMed Identifier
    4899510
    Citation
    Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. No abstract available.
    Results Reference
    background

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