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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05121233
• Other study ID #: pain in TUS guided procedures
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2021
• Est. completion date: October 2022

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: mostafa mahmoud ahmed
• Phone: 0201001554241
• Email: doc.mostafa5454[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Aspiration, Respiratory
• Lung Neoplasms
• Neoplasms
• Pleural Effusion
• Pleural Neoplasms
• Pneumothorax
• Pyothorax
• Respiratory Aspiration

Intervention

Drug:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 minutes
Primary	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"	30 minutes
Primary	performance time of transthoracic ultrasound guided procedures	assess the effect of its use with local anaesthesia on procedure performance compared to local anaesthesia alone	up to 20 minutes