Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time

A patient with an arteriovenous fistula (AVF) receiving chronic hemodialysis (HD) treatment is cannulated 312 times a year on average. The patients cannot comply with dialysis treatment and the quality of life is decreased by pain when the fistula cannot be accessed with a single attempt. Sharp pain depends on the tear in the skin, the tissue where the sensitive nerve ends receptive to pain are located, and it is particularly important during AVF puncture. Also, punctures are accompanied by haemorrhages and frequent loss of blood.

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Key information

Conditions

Pain Arteriovenous Fistula Arteriovenous Malformations Bleeding Time Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fistula Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Demiroglu Bilim University

Istanbul, 34384, Turkey (Türkiye)

About this study

The repeated puncture of the AVF leads to a considerable degree of pain, due to the calibre and length of the bevel of fistula needles. When the fistula needle is removed, the small punctures that occur in the entrance area are closed with a thrombus. As a result, scar tissue forms in the entrance area and the surrounding skin, which can lead to the development of stenosis and aneurysm. For this reason, the needle conical tip direction is important in terms of delaying the loss of tissue elasticity and prolonging the use of the intervention area. There are very few studies investigating the effect of the conical tip being up or down on the pain that develops during cannulation in the patient.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

18 years of age or older
On maintenance hemodialysis three times per week for four hours per session
Receiving hemodialysis therapy for a least six moths at the time of the study
Pain level of one or more measured by the Visual Analogue Scale during cannulation
Able to communicate in Turkish
Willing to participate to the study

Exclusion criteria

Known to be difficult to enter the fistula (with more than one cannulation)
History of hematoma or stenosis in fistula
Having an infection in the fistula area
Taking painkillers 3 hours before treatment

Treatment and study plan

Bevel Position

Other

During 6 dialysis sessions, cannulation was applied to the patients with the direction of the arterial needle in the antegrade direction and the conical tip facing upwards. In the next 6 dialysis sessions, cannulation was applied to the patients in an antegrade direction and with the conical tip facing down.

Primary outcomes

Change From Baseline Invasive Pain at 12 Dialysis Session

Time frame: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)

It will be assessed three times at the end of the dialysis session with Visual Analogue. Pain intensity measured on a Visual Analog Scale with scores ranging from 0 - 10. Pain increases as the score increases. The high point describes bad outcome.
Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session

Time frame: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)

Bleeding time was defined as the time (minutes) from the moment the pressure was applied to the moment when the bleeding stopped after the fistula needle was removed.

Sponsors and collaborators

Lead sponsor

Istanbul Demiroglu Bilim University

Other

Registry information

Official study title

Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time in Hemodialysis Patients

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Nov 10, 2021
Registry last updated: Nov 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed