| Registry | NCT05121233 |
|---|---|
| Status | Unknown |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: quadruple, supportive care |
| Enrollment | 100 (Estimated) |
| Sponsor | Assiut University (Other) |
| Conditions | Pleural Neoplasms, Aspiration, Respiratory, Pleural Effusion, Lung Neoplasms, Pneumothorax, Pyothorax |
| Interventions | Diclofenac, Placebo (Drug) |
| Dates | start 2021-11-01 (estimated), primary completion 2022-10-01 (estimated), completion 2022-10-01 (estimated), first posted 2021-11-16, last updated 2021-11-16 |
Related Papers Related Patents Related Grants Related Experts
All trials for Pleural Neoplasms All trials for Aspiration, Respiratory All trials of Diclofenac All trials of Placebo
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Diclofenac | Active comparator | Drug: Diclofenac | Group A will receive a single dose 75 mg IV diclofenac by infusion prior to the procedure |
| Placebo | Placebo comparator | Drug: Placebo | Group B who will receive placebo |
Sex: All, ages: 18 Years to 75 Years
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