NCT05121233

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Diclofenac	a single dose 75 mg IV diclofenac by infusion prior to the procedure
DRUG	Placebo	single dose iv placebo (saline ) by infusion prior to the procedure

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2021-11-16
• Last updated: 2021-11-16

Regulatory

• FDA-regulated drug study