Aspiration, Respiratory, Lung Neoplasms, Pleural Effusion, Pleural Neoplasms, Pneumothorax, Pyothorax
Conditions
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.
Interventions
DRUGDiclofenac
a single dose 75 mg IV diclofenac by infusion prior to the procedure
DRUGPlacebo
single dose iv placebo (saline ) by infusion prior to the procedure
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity assessed by Numerical Rating Scale (NRS) | 30 minutes | 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 |
| Satisfaction assessed by the Visual Analogue Scale (VAS) | 30 minutes | 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 |
| performance time of transthoracic ultrasound guided procedures | up to 20 minutes | assess the effect of its use with local anaesthesia on procedure performance compared to local anaesthesia alone |
Contacts
Primary Contactmostafa mahmoud ahmed
Outcome results
None listed