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CTRI Number  CTRI/2025/11/098001 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 24/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Pain and bledding stopage time ]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   A study to find out whether the direction of inserting dialysis needles affects pain and bleeding in patients with AV fistula 
Scientific Title of Study   Effect of Needle Orientation on AVF Cannulation Pain and Post-Removal Haemostasis in Haemodialysis Patients: A Crossover Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shashank R Nayak 
Designation  MSc Renal Replacement Therapy and Dialysis Technology 
Affiliation  Manipal College of Health Professions (MCHP) 
Address  1-22 Anangadi Bettu Karkala Taluku Guddeanagadi Kanajaru Udupi Karnataka 576113
Manipal College of Health Professions MCHP Manipal Madhav Nagar Eshwar Nagar Manipal 576104
Udupi
KARNATAKA
576113
India 
Phone  6361713168  
Fax    
Email  shashank.mchpmpl2024@learner.manipal.edu   
 
Details of Contact Person
Scientific Query  
Name  Dr Indu R Rao  
Designation  MD (General Medicine) DM(Nephrology) Associate Professor  
Affiliation  Kasturba Medical College (KMC) 
Address  Department of Nephrology KMC Manipal
Manipal Udupi district Karnataka 576104
Udupi
KARNATAKA
576104
India 
Phone  9592896393  
Fax    
Email  indu.rao@manipal.edu   
 
Details of Contact Person
Public Query  
Name  Veena N K  
Designation  M.Sc. Renal Replacement Therapy and Dialysis Technology Assistant Professor Selection Grade  
Affiliation  Manipal College of Health Professions Manipal 
Address  Renal Replacement Therapy & Dialysis Technology Program, Manipal College of Health Professions (MCHP) MAHE Manipal
Manipal College of Health Professions (MCHP) Manipal Madhav Nagar Eshwar Nagar Manipal 576104
Udupi
KARNATAKA
576104
India 
Phone  9844548651  
Fax    
Email  veena.nk@manipal.edu   
 
Source of Monetary or Material Support  
Kasturba Hospital KH Manipal Madhav Nagar Manipal Udupi District Karnataka India 576104 
 
Primary Sponsor  
Name  Shashank R Nayak 
Address  Kasturba Hospital (KH) Manipal Madhav Nagar, Manipal, Karnataka, with the pin code 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Indu R Rao  Kasturba Hospital KH Manipal  Department of Nephrology Dialysis Unit 3rd floor Kasturba Hospital KH Manipal Madhav Nagar Manipal Karnataka India 576104
Udupi
KARNATAKA 		 9592896393

indu.rao@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 and older who are receiving continuous haemodialysis for more than three months via an arteriovenous fistula.
2. Patients who are conscious oriented and able to understand and respond to the questionnaire.
3. Patients willing to provide informed consent. 
 
ExclusionCriteria 
Details  1. Haemodialysis patients with AVG as their permanent vascular access and patients with temporary access catheter
2. Difficulty in AVF cannulation in the last two weeks of dialysis more than one attempt at
cannulation needed for at least two sessions
3.Diminished mental capacity or not able to communicate  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
AVF cannulation pain as measured by the Numerical Rating Scale NRS AVF cannulation discomfort and bleeding time after removal depending on whether the bevel up or bevel down approach is utilized  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

1. Title

Effect of Needle Orientation on AVF Cannulation Pain and Post Removal Haemostasis in Haemodialysis Patients A Crossover Randomized Controlled Trial

2. Background & Rationale

Pain during AVF cannulation and prolonged post needle removal bleeding are common but often overlooked issues in hemodialysis. Evidence is conflicting

KDIGO recommends bevel up insertion.

Recent studies suggest bevel down may reduce pain and bleeding.

However few randomized controlled trials exist. This study will provide comparative evidence between the two routinely used standard cannulation methods.

3. Study Design

Type Investigator initiated single-blinded crossover Randomized Controlled Trial

Setting Hemodialysis Unit Kasturba Hospital Manipal

Study Period March 2025  March 2026

Total Sample

Patients 28

Dialysis staff survey 44

4. Objectives

Primary Objective

To compare pain during AVF cannulation between bevel-up and bevel-down needle orientation using the Numerical Rating Scale .

Secondary Objectives

To compare post needle removal bleeding time between the two orientations.

To assess dialysis staff preferences regarding bevel orientation.

5. Participants

Inclusion Patients

 less then18 years

On maintenance hemodialysis for more then 3 months via AVF

Conscious oriented and able to respond

Provide informed consent

Exclusion

AVG or catheter access

Difficult cannulation in last 2 weeks

Unable to communicate

Staff Eligibility Survey

more then 3 months AVF cannulation experience

Working in dialysis unit

Free during data collection time

6. Methods  Study Procedure

Eligible patients randomized into bevel up or bevel down group using computer generated sequence.

Visit 1 and 2 Cannulation per assigned orientation.

Visit 3 and 4 Crossover to the alternate orientation.

Pain assessed during each cannulation using NRS.

Bleeding time measured after needle removal.

Complications hematoma infiltration documented.

Staff complete an anonymized questionnaire assessing bevel orientation preference.

Note Both cannulation methods are part of routine care; no additional risk is introduced.


7. Outcomes


Primary Outcome


Pain score during cannulation NRS

Secondary Outcomes


Post needle removal bleeding time

Staff preference on bevel orientation

8. Statistical Analysis


Descriptive statistics for demographic variables.

Repeated Measures ANOVA or Friedman test for comparing pain and bleeding time.

Shapiro Wilk test for normality.

9. Risks & Benefits


Risks

No additional risk as both bevel up and bevel down are standard clinical methods.


Benefits

Potential to identify the technique offering least pain and best haemostasis improving patient comfort and clinical practice.


10. Ethics


IEC approval obtained.

Written informed consent mandatory.

Confidentiality and voluntary participation ensured.

Any complications managed as per hospital protocol at no additional cost to participants.

11. Funding


No external funding. No budget requirement.

 
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