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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05121233
Collaborator
(none)
100
2
11

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Diclofenac

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

Drug: Diclofenac
a single dose 75 mg IV diclofenac by infusion prior to the procedure

Placebo Comparator: Placebo

Group B who will receive placebo

Drug: Placebo
single dose iv placebo (saline ) by infusion prior to the procedure

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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"

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mostafa Mahmoud Ahmed AbdAllah, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05121233
Other Study ID Numbers:
  • pain in TUS guided procedures
First Posted:
Nov 16, 2021
Last Update Posted:
Nov 16, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2021