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

NCT05121233 | Unknown Phase 4 FDA Drug

• 1 other identifier: pain in TUS guided procedures
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Diclofenac

ACTIVE COMPARATOR

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

Drug: Diclofenac

Placebo

PLACEBO COMPARATOR

Group B who will receive placebo

Drug: Placebo

Interventions

Diclofenac DRUG

a single dose 75 mg IV diclofenac by infusion prior to the procedure

Diclofenac

Placebo DRUG

single dose iv placebo (saline ) by infusion prior to the procedure

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• 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.

  PMID: 23396954 BACKGROUND

• 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.

  PMID: 20696688 BACKGROUND

• 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.

  PMID: 26720026 BACKGROUND

• 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.

  PMID: 4899510 BACKGROUND

MeSH Terms

Conditions

Pleural Neoplasms; Respiratory Aspiration; Pleural Effusion; Lung Neoplasms; Pneumothorax; Empyema, Pleural

Interventions

Diclofenac

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Infections; Infections; Empyema; Suppuration; Inflammation

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Central Study Contacts

mostafa mahmoud ahmed

CONTACT

0201001554241; doc.mostafa5454@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: November 16, 2021
• Study Start: November 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 16, 2021

Record last verified: 2021-11