Efficacy & safety of topical Lidocaine and Prilocaine gel for arteriovenous fistula cannulation pain in hemodialysis patients A Crossover Randomized Control Trial

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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