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The 50:50 Nitrous Oxide vs 2% Lidocaine Challenge

2 september 2026 uppdaterad av: Ana Cvetković, Institute for Oncology and Radiology of Serbia

The 50:50 Nitrous Oxide Challenge: A Prospective Randomised Trial - Needle, Meet Your Match

The main goal of the project is to assess pain levels and patient comfort during the administration of a 50:50 Nitrous Oxide/Oxygen gas mixture, in comparison to the same parameters under the standard method used at our institution, which includes injecting a local anaesthetic at the site of planned puncture for central venous catheterisation.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

62

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Serbien
    • Savski Venac
      • Belgrade, Savski Venac, Serbien, 11000
        • Institute for Oncology and Radiology of Serbia

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria:

  • Subjects who have not previously received Nitrous Oxide.
  • Subjects of both sexes, aged between 18 and 65 inclusive.
  • Subjects who have signed informed consent with full disclosure; no study-related procedure may begin until the subject signs the consent form.

Exclusion Criteria:

  • Infection at the planned puncture site.
  • Pregnancy.
  • Intracranial hypertension.
  • Vitamin B12 deficiency.
  • Hemodynamic instability.
  • BMI over 35.
  • Glasgow Coma Scale (GCS) score less than 15.
  • Presence of chronic pain.
  • Neurological disorders.
  • Hematologic disorders.
  • Systemic or intrathecal methotrexate therapy
  • More than two attempts at venous puncture (Subject Withdrawal Criterion).
  • Subject experienced an adverse event requiring early discontinuation (Subject Withdrawal Criterion).
  • Withdrawal of consent by the subject (Subject Withdrawal Criterion)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Nitrous Oxide Group
This will be the experimental group in which the patients will receive a mixture of gases to assess the efficacy of the treatment compared to the control.
Läkemedel: Nitrous Oxide-Oxygen
After placing the patient in the appropriate supination + Trendelenburg position, the operative field (neck and subclavian region) is prepared using antiseptic measures.Five minutes before needle insertion, a mask connected to a 50:50 Nitrous Oxide/Oxygen cylinder with a flow rate of 6 liters per minute is placed on the patient's face and held by the patient. The mask has a valve that opens only when the patient creates negative pressure during inhalation.The patient is instructed to breathe spontaneously; the mask is removed once the catheter is inserted into the target vein or after cessation of painful stimulation.
Andra namn:
  • Experimental Treatment
Aktiv komparator: Lidocaine 2%
The control group receiving the standard of care for this intervention.
Läkemedel: Lidocaine 2% Injectable Solution
After placing the patient in the appropriate supination + Trendelenburg position, the operative field (neck and subclavian region) is prepared using antiseptic measures. Then, under ultrasound control, the most favorable central vein for puncture is determined (v. jugularis interna or v. subclavia) and a 25-gauge needle is used to infiltrate the skin and subcutaneous tissue above the selected vein with local anesthetic. Five minutes after infiltration, puncture of the selected vein is performed using the Seldinger technique. Continuous communication with the patient is maintained throughout the procedure.
Andra namn:
  • Kontrollera

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain Intensity During Needle Insertion
Tidsram: At the time of needle insertion
Assessed using a standard Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
At the time of needle insertion
Pain Intensity During Catheter Placement
Tidsram: During catheter placement
Assessed using a standard Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
During catheter placement
Pain Intensity Post-Intervention
Tidsram: 2 minutes after gas inhalation (Treatment 1) or 2 minutes post-intervention (Treatment 2)
Assessed using a standard Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
2 minutes after gas inhalation (Treatment 1) or 2 minutes post-intervention (Treatment 2)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient Anxiety Score
Tidsram: Post-intervention (at the conclusion of the central venous catheterization procedure)
Assessed using a standard Numeric Rating Scale (NRS) ranging from 0 (no anxiety) to 10 (worst imaginable anxiety). Higher scores indicate greater anxiety levels.
Post-intervention (at the conclusion of the central venous catheterization procedure)
Patient Satisfaction Score
Tidsram: Post-intervention (at the conclusion of the central venous catheterization procedure)
Assessed using a Numeric Rating Scale (NRS) where patients rate their overall satisfaction with the anesthetic method. The scale ranges from 0 (completely unsatisfied) to 4 (completely satisfied). Higher scores indicate greater satisfaction.
Post-intervention (at the conclusion of the central venous catheterization procedure)
Incidence of Treatment-Related Adverse Events
Tidsram: From the start of the intervention through 30 minutes post-procedure
Percentage of participants experiencing specific adverse events, including nausea/vomiting, unpleasant dreams, paresthesias, dizziness, and euphoria, as recorded by subjective patient reports.
From the start of the intervention through 30 minutes post-procedure

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Institute for Oncology and Radiology of Serbia

Utredare

  • Huvudutredare: Ana Cvetković, MD, PhD, Institute for Oncology and Radiology of Serbia

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 juni 2025

Primärt slutförande (Beräknad)

31 augusti 2026

Avslutad studie (Beräknad)

1 oktober 2026

Studieregistreringsdatum

Först inskickad

25 maj 2026

Först inskickad som uppfyllde QC-kriterierna

25 maj 2026

Första postat (Faktisk)

1 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 september 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 01-1/2025/1264

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

There is no current plan to share individual participant data to external registries.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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