Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale and Perfusion Index

June 21, 2025 updated by: Sinem Dogruyol, Haydarpasa Numune Training and Research Hospital

Evaluation of Analgesic Efficacy of Lidocaine and Diclofenac Spray in Radial Artery Blood Gas Sampling by Visual Analogue Scale (VAS) and Perfusion Index: A Randomised, Placebo-Controlled Study

The aim of this clinical trial is to evaluate the analgesic efficacy of lidocaine and diclofenac sprays to be administered before the procedure in cases admitted to the emergency department and requiring radial artery blood gas sampling by means of visual pain scale (VAS) and perfusion index in comparison with placebo. The main questions it aims to answer are:

1. Is there a difference between the efficacy of two different sprays? 2. Is there a significant difference between the side effects of two different sprays? Researchers will compare diclofenac sodium, lidocain and placebo sprays. Treatments will;

  1. be administered in same three spray bottles to ensure blinding in the groups.
  2. Randomisation will be done by closed envelope method.
  3. Numerical Pain Scale (NRS) will be used to evaluate the analgesic efficacy of the sprays. NRS scores will be recorded in both groups before starting blood gas sampling (baseline) and after blood gas sampling.
  4. Any side effects due to medication will be recorded.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Uskudar
      • Istanbul, Uskudar, Turkey, 34843
        • Haydarpasa Numune Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 18-65.
  • Having clinical indication for radial artery blood gas sampling
  • Being conscious, co-operative and orientated
  • Those who approved the informed consent form

Exclusion Criteria:

  • Being under 18 years of age.
  • Being pregnant or breastfeeding.
  • Not being conscious, co-operative and orientated (impaired consciousness)
  • Being used painkillers in the last 24 hours
  • Radial artery blood gas sampling on the same day (more than one application)
  • Presence of cardiac arrhythmia
  • Have a diagnosis of neuropathy (including diabetic neuropathy)
  • Having a diagnosis of anxiety and panic disorder
  • Using a sustained-release dermal analgesic patch (fentanyl)
  • Patient unable to comply with the visual analogue pain scale (VAS) due to language barrier
  • Presence of a condition such as dementia, etc. that may lead to a change in consciousness
  • Allergy to lidocaine or diclofenac

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I: 5-6 puffs of topical 10% lidocaine spray
Group I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling.
Drug: Lidocaine spray
Group I: 5-6 puffs of topical 10% lidocaine spray will be applied before radial artery blood gas sampling.
Active Comparator: Group II: topical 1% diclofenac spray
Group II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling.
Drug: Diclofenac
Group II: 5-6 puffs of topical 1% diclofenac spray will be applied before radial artery blood gas sampling.
Placebo Comparator: Group III: topical 70% alcohol solution spray
Group III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling.
Other: Placebo
Group III: 5-6 puffs of topical 70% alcohol solution spray will be applied before radial artery blood gas sampling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain scores associated with radial artery blood gas sampling
Time Frame: Baseline perfusion index and baseline VAS will be measured and recorded. 10 minutes after blood gas sampling, perfusion index and VAS score will be recorded.
The primary outcome of the study was the change in pain associated with radial artery blood gas sampling. It is aimed to provide patient comfort with spray applications. Differences between the 3 groups in VAS scores related to the intervention will be analysed.
Baseline perfusion index and baseline VAS will be measured and recorded. 10 minutes after blood gas sampling, perfusion index and VAS score will be recorded.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haydarpasa Numune Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

December 15, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

April 6, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 21, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-KAEK-64

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

12 months ( 01.01.2025-01.01.2026)

IPD Sharing Access Criteria

The researcher responsible for data analysis will be authorised to access IPD for 1 year.

IPD Sharing Supporting Information Type

  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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