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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrous Oxide Group | Experimental | 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. |
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| Lidocaine 2% | Active Comparator | The control group receiving the standard of care for this intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 2 minutes after gas inhalation (Treatment 1) or 2 minutes post-intervention (Treatment 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-intervention (at the conclusion of the central venous catheterization procedure) |
| Patient Satisfaction Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Cvetkovic, MD,PhD | Contact | +381 11 2067 100 | ana.cvetkovic@ncrc.ac.rs |
| Name | Affiliation | Role |
|---|---|---|
| Ana Cvetković, MD, PhD | Institute for Oncology and Radiology of Serbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Oncology and Radiology of Serbia | Recruiting | Belgrade | Savski Venac | 11000 | Serbia |
There is no current plan to share individual participant data to external registries.
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 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. |
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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 | 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 |
| D001523 | Mental Disorders |
| Aniline Compounds |
| D000588 | Amines |