NCT06253299

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

29 days

First QC Date

February 1, 2024

Last Update Submit

April 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Venous cannulation pain

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

    preoperative period

Secondary Outcomes (1)

  • heart rate

    preoperative period

Study Arms (2)

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

Other: marble stone

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.

Other: marble stone

Interventions

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."

Group LGroup R

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şenay Canikli Adıgüzel

Ataşehir, Samsun, 55025, Turkey (Türkiye)

Location

Related Links

Study Officials

  • Senay canikli adıgüzel

    Samsun University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical specialist (Anesthesiology and Reanimation)

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 12, 2024

Study Start

February 20, 2024

Primary Completion

March 20, 2024

Study Completion

March 30, 2024

Last Updated

April 15, 2024

Record last verified: 2024-04

Locations