Effect of 2% Lignocaine Medicated Pad (LMP) Administration on Pain Relief and Antibody Response During Rabies Immunoglobulin (RIG) Infiltration: A multicentric randomized controlled trial

Rationale The administration ofRabies Immunoglobulin RIG is a painful procedure. Local application of painrelieving medications has been used for many other procedures effectively. Assessing antibody titres helps to see whether a lignocaine medicated pad interferes with immune response. It also provides an opportunity to determine effective immune response and factors affecting it. Novelty No previous studies other than a small clinical trial by our team. Objectives To find the effect 2 percent Lignocaine Medicated Pad LMP on pain relief and antibody response during Rabies Immunoglobulin administration factors determining antibody response, frequency of adverse events following RIG administration and cost effectiveness of procedure. Methods A randomized triple blind controlled trial will be done in three sites in India in tertiary care settings. Patients with Category III animal bite wounds will be randomized to intervention and placebo arms based on a previously generated random number sequence. Sterile gauze pads soaked with 2% lignocaine and normal saline will be intervention and placebo, respectively. Pain relief and antibody response will be the primary outcomes measured. Pain relief will be assessed using a numeric rating scale NRS and sound, eye and motor pain SEM scale. Costeffectiveness will be assessed by calculating the incremental cost-effectiveness ratio ICER determining the willingness to pay WTP threshold by the contingent valuation method. If the ICER falls below this WTP threshold the intervention will be considered cost-effective. Expected Outcome A cost-effective procedure for pain relief during RIG administration, which can be included in the national policy and guidelines for rabies management.