The 50:50 Nitrous Oxide vs 2% Lidocaine Challenge

N/AActive Not RecruitingNCT07618676

Institute for Oncology and Radiology of Serbia62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Pain Anxiety Central Venous Catheter

Interventions

Nitrous Oxide-OxygenDRUG

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 SolutionDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Institute for Oncology and Radiology of Serbia

Belgrade, Savski Venac, Serbia

Outcomes

Primary Outcomes

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

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

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

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)

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)

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.

Data from ClinicalTrials.gov

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