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

Phase 4

• Conditions: Aspiration, Respiratory; Pneumothorax; Pleural Neoplasms; Pleural Effusion; Lung Neoplasms; Pyothorax
• Interventions: Drug: Placebo; Drug: Diclofenac

• Registration Number: NCT05121233
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study First Submitted: 2021-09-25
• Status Verified: 2021-11
• Study Start: 2021-11
• Study First Submitted QC: 2021-11-04
• Last Update Submitted: 2021-11-04
• Study First Posted: 2021-11-16
• Last Update Posted: 2021-11-16
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Group B who will receive placebo
Diclofenac	Diclofenac	Group A will receive a single dose 75 mg IV diclofenac by infusion prior to the procedure

Primary Outcome Measures

Name	Time	Method
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