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

Assiut University

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Diclofenac; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05121233

pain in TUS guided procedures

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Diclofenac

Active Comparator group

Description:

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

Treatment:

Drug: Diclofenac

Placebo

Placebo Comparator group

Description:

Group B who will receive placebo

Treatment:

Drug: Placebo