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CTRI Number  CTRI/2026/01/100657 [Registered on: 09/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study comparing a numbing cream and a patch to reduce pain from spinal needle insertion  
Scientific Title of Study   A Comparative Study of Eutectic Mixture of Local Anaesthetic Cream ( EMLA) and Lignocaine Patch ( 5%) to Alleviate Pain on Needle Insertion During Spinal Anaesthesia in a Tertiary Care Centre  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Narendra Babu M. C.  
Designation  Professor  
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre,Bangalore 
Address  Sapthagiri Institute of Medical Sciences and Research Centre, 15/1 Hesaraghatta Main Road, Chikkasandra, Bengaluru, Karnataka

Bangalore
KARNATAKA
560090
India 
Phone  99002140664  
Fax    
Email  narendrababuchanappa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Narendra Babu M. C.  
Designation  Postgraduate 
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre, Bangalore 
Address  Sapthagiri Institute of Medical Sciences and Research Centre, 15/1 Hesaraghatta Main Road, Chikkasandra, Bengaluru, Karnataka

Bangalore
KARNATAKA
560090
India 
Phone  8095353750  
Fax    
Email  narendrababuchanappa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Asma Kaleem Pasha 
Designation  Postgraduate 
Affiliation  Sapthagiri Institute of Medical Sciences and Research Centre, Bangalore 
Address  Sapthagiri Institute of Medical Sciences and Research Centre, 15/1 Hesaraghatta Main Road, Chikkasandra, Bengaluru, Karnataka

Bangalore
KARNATAKA
560090
India 
Phone  8095353750  
Fax    
Email  asmakp27@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Sapthagiri Institute of Medical Sciences and Research Centre, Hesaraghatta Main Road, Chikkasandra, Bengaluru – 560090, Karnataka, India. The study has no external funding and is supported by the institute with infrastructural and logistic facilities. Minor expenses are borne by the student investigator. 
 
Primary Sponsor  
Name  Sapthagiri Institute of Medical Sciences and Research Centre 
Address  No. 15, Chikkasandra, Hesaraghatta Main Road, Bangalore – 560090, Karnataka, India 
Type of Sponsor  Research institution and hospital 
 
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 Asma Kaleem Pasha  Sapthagiri Institute of Medical Sciences and Research Centre  Department of Anaesthesiology, 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA 
08095353750

asmakp27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , Sapthagiri Institute of Medical Sciences and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EMLA Cream (Eutectic Mixture of Local Anaesthetic Cream)  A topical anesthetic cream containing 2.5% lidocaine and 2.5% prilocaine, applied 1 hour before spinal needle insertion. 
Comparator Agent  Lignocaine Patch (5%)  A topical lignocaine patch containing 5% lignocaine, applied 1 hour before spinal needle insertion. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patient posted for infra umbilical surgical procedure under spinal anesthesia.
2 Age 18-60 years.
3 ASA grade I & II.
4 Weight of the patient 45-70 kgs.
5 Patient who consent for the procedure  
 
ExclusionCriteria 
Details  1 Patient not willing to participate in the study.
2 Contraindication for spinal anesthesia.
3 Hypersensitivity /Allergy to study drug.
4 Pregnant women or lactating women
5 More than three attempts of spinal needle insertion  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain score on spinal needle insertion using Visual Analogue Scale (VAS)  Immediately after spinal needle insertion  
 
Secondary Outcome  
Outcome  TimePoints 
measuring patient satisfaction, hemodynamic response, adverse effects  At the time of needle insertion, 5minutes, 10 minutes & 15 minutes after insertion 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 4 
Date of First Enrollment (India)   19/01/2026 
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="0"
Months="3"
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  
Spinal anesthesia is commonly used for surgeries of the lower limbs, pelvis and abdomen. The insertion of the spinal needle can cause discomfort and anxiety in many patients despite the overall good tolerance of the procedure. To reduce the pain of needle puncture, topical local anesthetics can be applied to the skin before spinal anesthesia. 

Eutectic Mixture of Local Anaesthetic cream containing 2.5 percent lignocaine and 2.5 percent prilocaine is widely used for skin anesthesia in pediatric venipuncture and lumbar puncture. Lignocaine patch 5 percent has been shown to reduce pain in conditions such as post herpetic neuralgia and painful diabetic neuropathy and is also effective in providing local analgesia. 

This randomized controlled study aims to compare the effectiveness of EMLA cream and 5 percent lignocaine patch in alleviating pain during spinal needle insertion. Ninety adult patients undergoing elective surgery under spinal anesthesia will be randomly allocated into two groups to receive either EMLA cream or lignocaine patch at the puncture site prior to the procedure. Pain during spinal needle insertion will be assessed using the Visual Analogue Scale. The primary outcome is the difference in pain scores between the two groups and secondary outcomes include ease of needle insertion and patient satisfaction. The study will be conducted at Sapthagiri Institute of Medical Sciences and Research Centre Bangalore.
 
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