Effect of Cold Application to Different Side Neck Region on Venous Cannulation Pain
How Applying Cold to Different Side Neck Region Affects Venous Cannulation Pain: Prospective Randomized Controlled Study
1 other identifier
observational
140
1 country
1
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
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Feb 2024
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2024
CompletedFirst Posted
Study publicly available on registry
February 12, 2024
CompletedStudy Start
First participant enrolled
February 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2024
CompletedApril 15, 2024
April 1, 2024
29 days
February 1, 2024
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
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.
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."
Eligibility Criteria
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)
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Senay canikli adıgüzel
Samsun University
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