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CTRI Number  CTRI/2026/02/104578 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 19/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Process of Care Changes 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Usefulness of a pad soaked with pain relieving medicine for Reducing Pain and Ensuring Effectiveness of Injections to prevent Rabies following animal exposures  
Scientific Title of Study   Effect of 2% Lignocaine Medicated Pad (LMP) Administration on Pain Relief and Antibody Response During Rabies Immunoglobulin (RIG) Infiltration: A multicentric randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Zinia Thajudeen Nujum 
Designation  Additional Professor 
Affiliation  School of Public Health, Kerala University of Health Sciences 
Address  School of Public Health , Kerala University of Health Sciences
Government Medical College, Thiruvananthapuram Campus
Thiruvananthapuram
KERALA
695011
India 
Phone  09037356908  
Fax    
Email  drzinia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Zinia Thajudeen Nujum 
Designation  Additional Professor 
Affiliation  School of Public Health, Kerala University of Health Sciences 
Address  School of Public Health , Kerala University of Health Sciences
Government Medical College, Thiruvananthapuram Campus
Thiruvananthapuram
KERALA
695011
India 
Phone  09037356908  
Fax    
Email  drzinia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Zinia Thajudeen Nujum 
Designation  Additional Professor 
Affiliation  School of Public Health, Kerala University of Health Sciences 
Address  School of Public Health , Kerala University of Health Sciences
Government Medical College, Thiruvananthapuram Campus
Thiruvananthapuram
KERALA
695011
India 
Phone  09037356908  
Fax    
Email  drzinia@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research Investigator initiated Small Grant Indian Council of Medical Research (ICMR) V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi – 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  Indian Council of Medical Research (ICMR) V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi – 110029, India  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Muraleedhar Thambe  BJ Medical College, Pune  BJ Medical College, Pune
Pune
MAHARASHTRA 
9423007898

muralidhartambe@gmail.com  
Chintha Sujatha  Government Medical College, Kollam  Government Medical College, Kollam
Kollam
KERALA 
9447375532

sujathachintha@gmail.com  
Asuma A Rahim  Government Medical College, Kozhikode  Preventive Clinic Government Medical College, Kozhikode
Kozhikode
KERALA 
9846120001

rahmaniyas@gmail.com  
Anitha Bhaskar   Government Medical College, Thiruvananthapuram  Preventive Clinic Government Medical College Thiruvananthapuram
Thiruvananthapuram
KERALA 
9447039135

dranithabhaskar@gmail.com 
Jugal Kishore   Vardhman Mahavir Medical College & Safdarjung Hospital, Delhi (VMMC & SJH)  Emergency Medicine, Vardhman Mahavir Medical College & Safdarjung Hospital, Delhi (VMMC & SJH)
New Delhi
DELHI 
9582792331

jk@drjugalkishore.com  
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Human ethics Committee, Government Medical College Kollam   Approved 
Human ethics Committee, Medical College Thiruvananthapuram  Approved 
Institutional Ethics Committee Government Medical College Kozhikode  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: W540||Bitten by dog, (2) ICD-10 Condition: W558||Contact with other mammals,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2% Lignocaine Medicated Pad   Dose 2% Lignocaine 5ml or the volume required to soak the pad and cover the wound frequency - single application twenty minutes before rabies immunoglobulin administration Route - local application Total duration - 20 minutes The procedure shall be done after administering the test dose of ERIG, so as to allow at least 20 minutes of contact with the local anaesthetic. Patient will be requested to lie in bed, in supine or prone position, depending on the site of wound. Sterile cotton pad shall be placed over the wound site. A number of such pads will be placed so as to cover the wound site. Lignocaine shall be instilled over the pads till the wet appearance is seen over the entire pads placed. The maximum volume of lignocaine will be 5ml, taken in a 5ml syringe. The pad will be securely plastered/ bandaged according to the site 
Comparator Agent  Normal Saline  Normal saline will be used as placebo. It will be taken in same type of syringe and the same volume as the intervention. The intervention and placebo shall be administered by the same person.  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult Patients more than 18 years coming to the Preventive Clinic or Antirabies clinic with Category three animal bites in whom Rabies Immunoglobulin Equine Rabies immunoglobulin or Human Rabies Immunoglobulin is advised.
Children between 12 and 18 years with Category three animal bites in whom Rabies Immunoglobulin Equine Rabies immunoglobulin Human Rabies Immunoglobulin is advised will also be recruited after completion of six months of data collection and after the first DSMB review
 
 
ExclusionCriteria 
Details  The exclusion criteria are those who are not giving consent, known allergy to Lignocaine, history of contact dermatitis, any contraindications to lignocaine and all mucosal exposures. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in Pain score in the intervention and control arm measured by Visual Analog Scale and Sound Eye Motor Scale  Before Rabies Immunoglobulin (RIG) administration
During RIG Administration
After RIG administration  
 
Secondary Outcome  
Outcome  TimePoints 
cost-effectiveness  one point after the procedure 
adverse events   till 42 days  
factors determining immune response  one point during analysis 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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   Phase 3 
Date of First Enrollment (India)   01/04/2026 
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="3"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response (Others) -  NIL
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 10-04-2029 and end date provided 10-04-2034?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Rationale The administration of Rabies 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. 

 
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