Clinical trial NCT05121233: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pleural Neoplasms
Aspiration, Respiratory
Pleural Effusion
Lung Neoplasms
Pneumothorax
Pyothorax
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pain intensity assessed by Numerical Rating Scale (NRS)
timeFrame: 30 minutes
measure: Satisfaction assessed by the Visual Analogue Scale (VAS)
timeFrame: 30 minutes
measure: performance time of transthoracic ultrasound guided procedures
timeFrame: up to 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
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.
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.
citation: 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.