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
About this trial
This is an interventional supportive care trial for Pleural Neoplasms
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
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
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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Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures
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