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CTRI Number  CTRI/2022/08/044614 [Registered on: 03/08/2022] Trial Registered Prospectively
Last Modified On: 28/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of analgesic efficacy of topical lignocaine-prilocaine cream with local infiltration of 2% lignocaine prior to spinal anaesthesia.  
Scientific Title of Study   Comparative evaluation of analgesic efficacy of topical EMLA cream with local infiltration of 2% lignocaine prior to subarachnoid block. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajmala Jaiswal 
Designation  Senior Professor 
Affiliation  Pandit BD Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical Care, Pandit BD Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9468197449  
Fax    
Email  para3007@rediff.com  
 
Details of Contact Person
Scientific Query
 
Name  Teyiesito Yano 
Designation  Post Graduate Student 
Affiliation  Pandit BD Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical Care, Pandit BD Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9774921342  
Fax    
Email  teyie.yano@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Teyiesito Yano  
Designation  Post Graduate Student 
Affiliation  Pandit BD Sharma PGIMS, Rohtak 
Address  Department of Anaesthesiology and Critical Care, Pandit BD Sharma PGIMS, Rohtak

Rohtak
HARYANA
124001
India 
Phone  9774921342  
Fax    
Email  teyie.yano@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, Pandit BD Sharma Post Graduate Institute of Medical Sciences, Pandit BD Sharma University of Health Sciences, Rohtak, Hayrana - 124001 
 
Primary Sponsor  
Name  Pandit BD Sharma PGIMS Rohtak 
Address  Department of Anaesthesiology and Critical Care, Pandit BD Sharma PGIMS, Rohtak 
Type of Sponsor  Government medical college 
 
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 
Teyiesito Yano  Pandit BD Sharma Post Graduate Institute of Medical Sciences, Rohtak  Department of Anaesthesiology and Critical Care, Pandit BD Sharma PGIMS, Rohtak
Rohtak
HARYANA 
9774921342

teyie.yano@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Committee, PGIMS/UHS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Local infiltration of 2% lignocaine  This group will include 30 patients in whom skin and deeper structures will be infiltrated with 2ml of 2% lignocaine just prior to lumbar puncture.  
Intervention  Topical application of Eutectic Mixture of Local Anaesthetics (EMLA) cream   This group will include 30 patients in whom 2.5 gms of 5% EMLA cream per 10sq.cm will be applied for a minimum of 60 minutes prior to lumbar puncture and covered with an occlusive dressing. After the prescribed time of application of EMLA cream, the occlusive dressing will be removed. The area will be then wiped dry with gauze and observed for signs of any local reactions. Lumbar puncture will be performed after cleaning and draping.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of the age 18-60 years, of either sex belonging to ASA grade I and grade II undergoing
1. elective lower abdominal surgery
2. pelvic surgery
3.lower limb surgeries will be selected 
 
ExclusionCriteria 
Details  Following patients will be excluded
1.Patients allergic EMLA cream or any other local anaesthetics.
2. Pregnant and lactating females.
3. Patients with methaemoglobinaemia
4. Psychiatric disorders
5. Fractures
6. More than 3 attempts at lumbar puncture  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
•Primary objective - To compare the VAS score and 4-point pain score of topical EMLA cream with Lignocaine infiltration during subarachnoid block.  1.VAS Score will be assessed immediately (within 5 minutes) after lumbar subarachnoid block on the scale of 0-10.

2.the 4-point pain scale will be assessed at the time of spinal needle insertion as:
0 – no response
1 - mild facial grimace
2 - verbal response
3 - movement of the back
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective -
1. Haemodynamic response to pain,
2. patients’ satisfaction with analgesia technique,
3. side effects  
1. Haemodynamic response will be measured immediately (within 2 minutes) before and after(within 2minutes) the lumbar subarachnoid block.

2. Patients satisfaction will be assessed immediatey after lumbar subarachnoid block, within 5 minutes before the start of surgery.

3.Patient will be follow up upto 24 hours for any side effects  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/08/2022 
Date of Study Completion (India) 23/11/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Spinal anaesthesia is a simple, fast, safe and reliable method for surgery of the lower body that provides profound sensory and motor block by a single use of spinal needle to administer local anaesthetics into the subarachnoid space.1It is usually administered in the lumbar region in L3-L4 or L4-L5 space. The main reasons for rejecting neuraxial blocks are fear of needle, backache as well as anticipated immediate pain associated with lumbar puncture.2 Lumbar puncture requires more cooperation of the patients and may at times need multiple punctures which may cause pain and apprehensions in patients. Relieving the lumbar puncture pain not only increases the patient’s satisfaction and comfort, but also let the anaesthetist apply spinal puncture fast and easily.3

        Lignocaine 2% solution is routinely used for infiltration of skin and subcutaneous tissues before lumbar puncture to reduce needle prick pain. Infiltration of local anaesthetics requires needle insertion which may itself cause acute pain and discomfort to the patient, may cause masking of anatomical landmarks which are used to identify the lumbar spaces and risks of accidental intravascular administrations.4 EMLA cream provides a non-invasive analgesia and has been effectively used in many studies to reduce needle prick pain.5,6

        Eutectic mixture of local anaesthetics (EMLA) is an effective topical anaesthetic mixture containing lignocaine and prilocaine. The mixture is termed eutectic as it has a melting point lower than its individual components. The mixture is liquid at room temperature while the individual components are crystalline substances. EMLA is used for relieving the pain caused during venous and intra-arterial cannula insertions in paediatrics and adult patients, excision of cutaneous lesions, radiofrequency ablation of warts, fine-needle aspiration of thyroid nodules, minor surgical procedures such as during perineal repair after childbirth, for pain control during shockwave lithotripsy, humeral block placement in non-sedated patients, peribulbar injection, mammography, transrectal biopsy of prostate, hysterosalpingography, IUD insertions,  dental procedures, epidural injections and lumbar punctures.5,6

The purpose of this study is to find out the efficacy of topical EMLA cream in comparison to the standard infiltration technique in reducing pain of needle insertion during lumbar subarachnoid block and have better patient satisfaction level.

 
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