Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures
NCT ID: NCT05121233
Last Updated: 2021-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2021-11-30
2022-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Diclofenac
Group A will receive a single dose 75 mg IV diclofenac by infusion prior to the procedure
Diclofenac
a single dose 75 mg IV diclofenac by infusion prior to the procedure
Placebo
Group B who will receive placebo
Placebo
single dose iv placebo (saline ) by infusion prior to the procedure
Interventions
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Diclofenac
a single dose 75 mg IV diclofenac by infusion prior to the procedure
Placebo
single dose iv placebo (saline ) by infusion prior to the procedure
Eligibility Criteria
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Inclusion Criteria
* Patients with pleural effusion, pneumothorax, lung mass or chest wall mass accessible for thoracic ultrasound guided intervention
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mostafa Mahmoud Ahmed AbdAllah
Principal investigator
Central Contacts
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References
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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.
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.
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.
Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. doi: 10.1177/003591576906201005. No abstract available.
Other Identifiers
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pain in TUS guided procedures
Identifier Type: -
Identifier Source: org_study_id