AzTrials
AzTrials

Venous Canulation PainNCT06253299

Effect of Cold Application to Different Side Neck Region on Venous Cannulation Pain

An observational study of Venous Canulation Pain and Nervous Vagus, run by Samsun University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Intravenous (iv) cannulation is one of the most common applications performed by anesthesiologists in and outside the operating room. It is necessary to provide vascular access before any anesthetic procedure. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Venous Canulation Pain, Nervous Vagus, Left Side
What is being tested?
marble stone
How many people
140 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Feb 2024to 30 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Adult, Older adult

Study population: Patients between the ages of 18-75 who will undergo elective surgery

Who may be able to join

  • 18-75 years old
  • ASA I,II,III patients
  • Patients who will undergo elective surgery

Who cannot join

  • -Patients undergoing emergency surgery
  • Patients who will undergo oncological surgery
  • Pregnant patients
  • Patients with scars on the back of the hand
  • Who had surgery on the back of the hand
  • Patients with psoriasis
Show all 18Show fewer
  • Those with peripheral vascular disease
  • Patients using chronic analgesics
  • Patients using opioids
  • Those who use steroids
  • Those who use gabapentinoids
  • Those with a history of substance use
  • Those with peripheral neuropathy
  • Patients who have received oncological treatment
  • Patients with limited cooperation
  • Patients using medications that affect heart rate (such as beta blockers, calcium channel blockers)
  • Patients with rhythm disorders
  • Patients using cardiac pacemaker

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Şenay Canikli Adıgüzel

    Ataşehir, Samsun, 55025

Other trials in Turkey (Türkiye)

About this study

Official title: How Applying Cold to Different Side Neck Region Affects Venous Cannulation Pain: Prospective Randomized Controlled Study

Intravenous (iv) cannulation is one of the most common applications performed by anesthesiologists in and outside the operating room. It is necessary to provide vascular access before any anesthetic procedure. Venous cannulation is a moderately painful procedure and is uncomfortable for patients, and the pain of intravenous cannulation may increase the patient's stress. Various methods are used to reduce cannulation pain. Stimulation of the N. Vagus is also among these methods (1). The branches of N. Vagus are densely located under the skin in the auricle and on the lateral aspect of the neck. It is thought that the dominance of the right and left vagal nerve over different systems is different. For example; While the right vagal branches are thought to be more effective on heart rate, the left side vagal branches are thought to be more effective in the treatment of refractory epilepsy. Purpose: Our aim in this study is to evaluate the vascular access pain in our patients to whom investigator applied venous cannulation from the back of the hand before anesthesia, by stimulating the Vagus Nerve with cold application to the neck area on both sides separately.

Read the detailed description

Various methods are being tried to reduce cannulation pain. Methods such as injection of local anesthetic into the intervention area, use of topical anesthetic, application of ice, and vibrating buzz application have been used to relieve the patient's pain and distract him. There are many different methods of stimulating the vagus nerve. Valsalva maneuver is a mechanism that stimulates Nervus Vagus (N. Vagus). Stimulation of the vagus nerve is thought to have an analgesic effect (2). Stimulation of the vagal nerve has an antinociceptive effect by triggering the baroreceptor reflex arc. It is thought that antinociceptive substance P-like substance is released with the activation of the baroreceptor reflex arc. The areas where N. Vagus is most superficial in the periphery are inside the auricle and the lateral neck region. It is also known that cold application to the lateral neck area reduces the heart rate by stimulating the N. Vagus (5). The degree of effect of vagal stimulation from different sides on different systems may be different (2,3). Applying cold to the neck area will have an antinociceptive effect by activating the baroreceptor reflex arc by stimulating the N. Vagus, and the degree of this effect may be effective differently with stimulation from the right or left side.

Method:

Patients aged 18-75 who will undergo elective surgery (except those who will undergo oncological surgery and those who will undergo cesarean section) will be included in the study. These patients will be evaluated at the anesthesia clinic before the operation. Those who have a scar on the back of the hand, who have had surgery on the back of the hand, who have psoriasis, who have peripheral vascular disease, who use chronic analgesics, who use opioids, who use steroids, who use gabapentinoids, who have a history of substance use, who have peripheral neuropathy, who have received oncological treatment and who have limited cooperation. patients will not be included in the study. Power analysis was done with G*Power 3.1.9.7 program. Before the study, the program was run to calculate the sample size to be equally distributed among the groups, assuming α = 0.05, power (1-β) = 0.80, effect size = 0.5. According to this program, the total number of samples is 128 and there are 64 people in each group. Taking into account recording errors, 70 people in each group and the total sample size was determined as 140 people) will be randomized into 2 groups: Group R (right side) and Group L (left side). The lottery method will be used for randomization.

Group R: Just before the vascular access is opened, a 4x5 cm cold marble stone will be held on the carotid in the right lateral neck area (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds (sec), and then the vascular access will be opened.

Group L: Just before the vascular access is opened, a 4x5 cm sized marble stone will be applied to the carotid in the left lateral neck region (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds, and then the vascular access will be opened.

Before vascular access is established, heart rate (HR), respiratory rate (RR) and noninvasive blood pressure (NIBB) will be recorded. HR, RR and NIBB values will be recorded after application to the neck area. Then, an 18-gauge (green colored) intraket will be inserted one time by the same experienced practitioner on the back of the left hand, and the patients will be asked to rate their pain levels between 0-10 according to the NRS and this value will be recorded. HR, RR and NIBB values will also be recorded. Patients who cannot be cannulated at once will be excluded from the study.

Patients' data will be recorded using SPSS 18 program. The relationship between the NRS scores of both groups and the patients' HR, RR and NIBB values before cold application, after cold application and during vascular access will be evaluated. Descriptive statistics, analysis of variance and chi-square test will be used to evaluate the data. Mean±standard deviation and percentages will be used in descriptive statistics. Results will be evaluated at 95% confidence interval and significance at p<0.05.

Being tested
marble stone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • marble stoneOther

    Marble stones with dimensions of 4x5 cm will be used for cold application. When placed in the freezer compartment of the refrigerator at -10°C (Celsius) for 4 minutes, they cool down to 11°C. Subsequently, in 1 minute, the temperature rises to 12°C when held in the palm. "After being placed on a table at room temperature, it reaches 18°C in 5 minutes."

Study groups in NCT06253299
Study groupRoleWhat they receive
Group LJust before the vascular access is opened, a 4x5 cm sized marble stone will be applied to the carotid in the left lateral neck region (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds, and then the vascular access will be opened
Receives: Other: marble stone
Group RJust before the vascular access is opened, a 4x5 cm cold marble stone will be held on the carotid in the right lateral neck area (2-3 cm above the clavicle, on the sternocleidomastoid muscle (SKM)) for 30 seconds (sec), and then the vascular access will be opened.
Receives: Other: marble stone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Venous cannulation pain

    Venous cannulation pain will be evaluated with the numerical pain scale (NRS).

    Measured: preoperative period

Secondary outcomes (1)
  1. heart rate

    Measured: preoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2024
  2. Study start20 Feb 2024
  3. Primary completion20 Mar 2024
  4. Study completion30 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06253299
Sponsor's protocol ID
GOKAEK 2024/3/9
Status last verified
Apr 2024
First submitted
1 Feb 2024
Last updated
15 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Venous Canulation Pain and Nervous Vagus, run by Samsun University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Venous cannulation pain (time frame: preoperative period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024; AzTrials last refreshed its copy on 2 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in