Health TrialsbyHealthPanel

The 50:50 Nitrous Oxide vs 2% Lidocaine Challenge

ConditionsAcute PainAnxietyCentral Venous Catheter
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInstitute for Oncology and Radiology of Serbia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Infection at the planned puncture site.

Pregnancy.

Intracranial hypertension.

Vitamin B12 deficiency.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nitrous Oxide-Oxygen

    Drug

    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.

  • Lidocaine 2% Injectable Solution

    Drug

    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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Nitrous Oxide GroupExperimental treatment 1 intervention
Group B: Lidocaine 2%Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity During 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.

Time frame
At the time of needle insertion
2

Pain Intensity 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.

Time frame
During catheter placement
3

Pain Intensity Post-Intervention

Assessed using a standard Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.

Time frame
2 minutes after gas inhalation (Treatment 1) or 2 minutes post-intervention (Treatment 2)

Secondary outcomes

1

Patient Anxiety Score

Assessed using a standard Numeric Rating Scale (NRS) ranging from 0 (no anxiety) to 10 (worst imaginable anxiety). Higher scores indicate greater anxiety levels.

Time frame
Post-intervention (at the conclusion of the central venous catheterization procedure)
2

Patient Satisfaction Score

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.

Time frame
Post-intervention (at the conclusion of the central venous catheterization procedure)
3

Incidence of Treatment-Related Adverse Events

Percentage of participants experiencing specific adverse events, including nausea/vomiting, unpleasant dreams, paresthesias, dizziness, and euphoria, as recorded by subjective patient reports.

Time frame
From the start of the intervention through 30 minutes post-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute for Oncology and Radiology of Serbia

Lead sponsor

Source ClinicalTrials.gov
Apply now