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CTRI Number  CTRI/2024/09/073516 [Registered on: 06/09/2024] Trial Registered Prospectively
Last Modified On: 03/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Effect and safety of topical gel containing a combination of Lidocaine and Prilocaine in the management of hemodialysis needling pain in patients on long term dialysis 
Scientific Title of Study   Efficacy & safety of topical Lidocaine and Prilocaine gel for arteriovenous fistula cannulation pain in hemodialysis patients A Crossover Randomized Control 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  Pratik R Kacheriki 
Designation  MSc RRT & DT 
Affiliation  Manipal College of Health Professions MCHP MAHE Manipal 
Address  RRT & DT Program, Manipal College of Health Professions, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9110882242  
Fax    
Email  pratik.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Indu R Rao 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Nephrology, KMC, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9592896393  
Fax    
Email  indu.rao@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Indu R Rao 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Nephrology, KMC, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9592896393  
Fax    
Email  indu.rao@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions MAHE Manipal Karnataka India 576104  
 
Primary Sponsor  
Name  Manipal College of Health Professions  
Address  RRT & DT Program Manipal College of Health Professions, MAHE, Manipal, India 576104 
Type of Sponsor  Research institution 
 
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 Medical College   Hemodialysis unit,Department of Nephrology,MAHE, Manipal, 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 
Intervention  Lidocaine 2.5% and Prilocaine 2.5% gel  A thick layer of gel will be applied to the skin, under occlusive dressing on the arteriovenous fistula hand where the needles will be inserted, for a time period of 60 minutes  
Comparator Agent  Placebo gel   A thick layer of gel will be applied to the skin, under occlusive dressing on the arteriovenous fistula hand where the needles will be inserted, for a time period of 60 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients on hemodialysis through an arteriovenous fistula.
Greater than three months of maintenance hemodialysis.
Those who rate their pain as mild, moderate or severe on AVF cannulation pain (as measured by VAS) during screening.

 
 
ExclusionCriteria 
Details  Hemodialysis patients with AVG as their permanent vascular access and patients with temporary access like catheters.
Hemodynamically unstable patients.
Skin infections or skin lesions or open wounds or ulcers.
Diminished mental capacity or not able to communicate.
Any known history of allergic reactions to lignocaine or prilocaine or any other topical anesthetics or other drugs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in AVF cannulation pain (as measured by the Visual Analogue Scale) score from baseline.   Day 1, Day 3  
 
Secondary Outcome  
Outcome  TimePoints 
Safety of topical Lidocaine and Prilocaine gel in AVF cannulation pain   Day 1, Day 3 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   24/09/2024 
Date of Study Completion (India) 31/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  
The participants are hemodialysis patients who require hemodialysis treatment weekly twice or thrice. The patients will regularly come to the dialysis unit at Kasturba Hospital for treatment.
Screening of patients who rate their needling pain as mild to moderate or severe will be done during the screening. Those patients will be selected, the study will be explained to them, and then informed consent will be obtained. Random allocation will be done by computer-generated randomisation. Random allocation of the participants into the treatment group (Lignocaine & prilocaine gel ) and control group (placebo group). The baseline data collection of needle prick pain will be measured through VAS (on a scale of no pain to severe pain ) for all patients. 
The participants under the Lignocaine & Prilocaine gel and Placebo group will receive the application on the fistula hand where the needles will be inserted. After at least 60 min, the fistula hand will be cleaned using skin disinfectants according to the unit protocol, and the cannulation will be performed.
Immediately, the pain will be measured through VAS. Two pain severity rating measurements will be taken for two continuous dialysis sessions for each group. The treatments will be crossed over, and  two pain severity measurements will be taken for each group. The assessment of pain will be done by the dialysis nurse/ intern, who is blinded to the group allocation.

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