Clinical trial NCT05115448: Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time
Official title: Effect of Bevel Position of the Artery Needle on Puncture Pain and Post-puncture Bleeding Time in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Bleeding Time
Arteriovenous Fistula
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline Invasive Pain at 12 Dialysis Session
timeFrame: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)
measure: Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session
timeFrame: At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demiroglu Bilim University
Study officials:
References:
citation: Crespo Montero R, Rivero Arellano F, Contreras Abad MD, Martinez Gomez A, Fuentes Galan MI. Pain degree and skin damage during arterio-venous fistula puncture. EDTNA ERCA J. 2004 Oct-Dec;30(4):208-12. doi: 10.1111/j.1755-6686.2004.tb00369.x.
citation: Gaspar LJ, Moreira NM, Moutinho AA, Pinto PJ, Lima HB, Rodrigues F. Puncture of the arteriovenous fistula: bevel upward or bevel downward? EDTNA ERCA J. 2003 Apr-Jun;29(2):104. doi: 10.1111/j.1755-6686.2003.tb00284.x. No abstract available.
citation: Marticorena RM, Donnelly SM. Impact of needles in vascular access for hemodialysis. J Vasc Access. 2016 Mar;17 Suppl 1:S32-7. doi: 10.5301/jva.5000534. Epub 2016 Mar 6.