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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Diclofenac
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diclofenac<br>Group A will receive a single dose 75 mg IV diclofenac by infusion prior to the procedure | Drug: Diclofenac<br>* a single dose 75 mg IV diclofenac by infusion prior to the procedure<br>|
| Placebo Comparator: Placebo<br>Group B who will receive placebo | Drug: Placebo<br>* single dose iv placebo (saline ) by infusion prior to the procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |