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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05115448
• Other study ID #: 07/16/2019
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: November 2021
• Source: Istanbul Demiroglu Bilim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Bleeding Time
• Fistula
• Hemorrhage
• Pain

Intervention

Other:
• Bevel Position
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.

Locations

Country	Name	City	State
Turkey	Demiroglu Bilim University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Crespo Montero R, Rivero Arellano F, Contreras Abad MD, Martínez Gómez A, Fuentes Galán MI. Pain degree and skin damage during arterio-venous fistula puncture. EDTNA ERCA J. 2004 Oct-Dec;30(4):208-12. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline Invasive Pain at 12 Dialysis Session	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.	At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)
Primary	Change From Baseline Post-Puncture Bleeding at 12 Dialysis Session	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.	At the end of the every dialysis session during one month (3 hemodialysis sessions are done every week)