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CTRI Number  CTRI/2025/04/083761 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 06/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   “Study on the effect of EMLA cream (lidocaine and prilocaine) in reducing throat pain after general anaesthesia: A randomised controlled study.” 
Scientific Title of Study   TO EVALUATE THE EFFECT OF EUTECTIC MIXTURE OF LOCAL ANAESTHETIC-EMLA(LIDOCAINE 2.5 PERCENT AND PRILOCAINE 2.5 PERCENT) ON POST OPERATIVE SORE THROAT FOLLOWING GENERAL ENDOTRACHEAL INTUBATION. ONE YEAR DOUBLE BLIND RANDOMISED PLACEBO CONTROL STUDY AT KLE’s DR PRABHAKAR KORE HOSPITAL. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeevitha V 
Designation  Junior resident  
Affiliation  KLE’s University-Jawaharlal Nehru medical college , Belgaum  
Address  Department of anaesthesiology, KAHERs Jawaharlal Nehru medical college , Nehru Nagar, Belgaum -590010, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  9972933412  
Fax    
Email  jeevitha.swaron@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M G Dhorigol  
Designation  Professor  
Affiliation  KLE’s University-Jawaharlal Nehru medical college , Belgaum  
Address  Department of anaesthesiology, KAHERs Jawaharlal Nehru medical college , Nehru Nagar, Belgaum -590010, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  9844778096  
Fax    
Email  mallappa.dhorigol@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jeevitha V 
Designation  Junior resident  
Affiliation  KLE’s University-Jawaharlal Nehru medical college , Belgaum  
Address  Department of anaesthesiology, KAHERs Jawaharlal Nehru medical college , Nehru Nagar, Belgaum -590010, Karnataka.

Belgaum
KARNATAKA
590010
India 
Phone  9972933412  
Fax    
Email  jeevitha.swaron@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru medical college, belagavi 590010 
 
Primary Sponsor  
Name  Jeevitha V 
Address  Department of anaesthesiology, KAHERs Jawaharlal Nehru medical college, Nehru Nagar, Belagavi 590010 
Type of Sponsor  Other [Self] 
 
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 Jeevitha V  Jawaharlal Nehru Medical College, Belagavi   Room No 30, Department of anaesthesiology, KAHERs Jawaharlal Nehru medical college, Belagavi 590010
Belgaum
KARNATAKA 		 9972933412

jeevitha.swaron@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Instituitional Ethics Committee  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 
Intervention  EMLA cream (lidocaine and prilocaine)  Postoperative sore throat (POST) after tracheal intubation is a destressing complaint in adults. Endotracheal intubation frequently results in sore throat which can be highly upsetting for the patient and causes sleep disturbances and unpleasant recollections. This study aims to know the incidence and severity of Postoperative sore throat after general Endotracheal intubation in adults using eutectic mixture of local anaesthetic. After obtaining the approval of ethical committee, patient undergoing elective surgery under general anaesthesia and meeting the inclusion criteria, informed consent will be obtained. A-thorough pre-anaesthetic evaluation will be done on the day before the surgery and will be advised for 8 hours of nil per mouth. On the day of the surgery the nil per mouth status will be confirmed and intravenous cannula will be secured on the forearm. For all patients aspiration prophylaxis will be given with i.v. Pantoprazole 40 mg and i.v. Ondansetron 8 mg as a premedication. Baseline blood pressure and heart rate will be noted as pre-operative reading. Standard monitoring will be done by continuous recording of noninvasive blood pressure, electrocardiogram, saturation level and ETCO2 level. In all patients pre- medication of i.v. Glycopyrolate 0.005mg per kg, i.v. Midazolam 0.05mg per kg, i.v. Fentanyl 2mcg per kg will be given. General anesthesia will be induced with. i.v. Propofol (titrated dose) 2 mg per kg ,i.v Succinylcholine 2mg per kg. Intubation will be done using appropriate size of Endotracheal tube.Prior to intubation Endotracheal tube cuff will be lubricated with 5 percentage of EMLA cream(intervention)Patients in the EMLA group receives 2.5 mL of EMLA cream. The volume of EMLA cream will be measured in a disposable syringe, and then the cream will be applied over the cuff and the distal portion of the ETT. Immediately after intubation and confirmation of the tube position, the ETT cuffs will be inflated with air and cuff pressure will be adjusted to 20-30cm of H2O. Anaesthesia will be maintained with a titrated dose of Isoflurane in oxygen and N2O.IV bolus of Vecuronium 0.1mg per kg or Atracurium 0.5 mg per kg will be repeated intermittently to maintain muscle relaxation. At the end of surgery Isoflurane will be discontinued, reversal Neuromuscular blockade will be given with Neostigmine 0.05 mg per kg and Glycopyrolate 0.01 mg per kg. After regaining of consciousness, the ETT cuff will be deflated, and the patient will be extubated after through ora-pharyngeal suctioning. Patient will be shifted to post anaesthesia care unit. Patient will be supplementing with oxygen and vitals will be monitored. Patient will be observed postoperatively in the post anaesthesia care unit and the ward at specified time points for evaluation of post operative sore throat and grading will be done accordingly at 10 mins, 6hrs,24hrs and 48hrs. 
Comparator Agent  KY jelly(placebo group)  After ethical committee approval, informed consent will be obtained from patients undergoing elective surgery under general anesthesia. A pre-anesthetic evaluation will be conducted a day before surgery, advising 8 hours of NBM. On the surgery day, NBM status will be confirmed, and an IV cannula secured. Aspiration prophylaxis includes IV Pantoprazole 40 mg and IV Ondansetron 8 mg. Baseline BP and HR will be recorded. Standard monitoring (NIBP, ECG, SpO2, ETCO2) will be done. Premedication includes IV Glycopyrrolate 0.005 mg/kg, IV Midazolam 0.05 mg/kg, and IV Fentanyl 2 mcg/kg. Anesthesia will be induced with IV Propofol 2 mg/kg and IV Succinylcholine 2 mg/kg. Intubation will be performed using an appropriately sized ETT. After confirming ETT placement, the cuff will be inflated to 20–30 cmH2O. Patients in the KY Jelly group will receive 2.5 mL of KY Jelly, applied over the cuff and distal ETT. Anesthesia will be maintained with Isoflurane, O2, and N2O. IV Vecuronium 0.1 mg/kg or Atracurium 0.5 mg/kg will be given as needed. At the end, Isoflurane will be discontinued, and neuromuscular blockade reversed with IV Neostigmine 0.05 mg/kg and Glycopyrrolate 0.01 mg/kg. After consciousness is regained, the ETT cuff will be deflated, and the patient extubated post-suctioning. In PACU, patients will receive oxygen, and vitals will be monitored. Postoperative sore throat will be assessed at 10 min, 6 hrs, 24 hrs, and 48 hrs. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Adult patients of either sex aged 18 to 65 years.
2. American Society of Anaesthesiologists (ASA) physical status I and II.
3. scheduled for elective surgeries with an expected duration of 1 to 3 hours under general endotracheal anesthesia. 
 
ExclusionCriteria 
Details  1. known allergy to Local anaesthetic
2. More then 2 intubation attempts
3. patients with head and neck surgery involving airway.
4. preoperative sore throat
5. difficult airway expected prolonged surgical duration lasting for more than 3 hours.
6. Surgeries in prone position 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To asses the effect of Eutectic mixture of local anaesthetic-EMLA (lidocaine 2.5% and prilocaine 2.5%) on the incidence and severity of postoperative sore throat in adults following general endotracheal intubation   10 minutes, 6 hours, 24 hours, and 48 hours post-extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the severity of postoperative cough following general endotracheal intubation.  10 minutes, 6 hours, 24 hours, and 48 hours post-extubation. 
 
Target Sample Size   Total Sample Size="122"
Sample Size from India="122" 
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)   09/04/2026 
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="1"
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 - NO
Brief Summary  

Postoperative sore throat (POST) is a common and distressing complication in patients undergoing elective surgery following endotracheal intubation under general anesthesia. Factors such as endotracheal tube (ETT) size, cuff pressure, and airway trauma contribute to its incidence. Pharmacological interventions, including topical local anesthetics, have been explored to mitigate POST.

This randomized, double-blind, placebo-controlled study aims to evaluate the effect of the eutectic mixture of local anesthetic (EMLA), comprising 2.5% lidocaine and 2.5% prilocaine, on the incidence and severity of POST in adult patients undergoing elective surgery. Patients will be randomly assigned to receive either EMLA cream or a placebo (water-based gel) applied to the ETT cuff before intubation. The primary outcome will be the incidence and severity of POST at 10 minutes, 6 hours, 24 hours, and 48 hours post-extubation. Secondary outcomes include the assessment of postoperative cough.

By evaluating the efficacy of EMLA in reducing POST, this study aims to provide insights into an effective, non-invasive intervention to enhance patient comfort and postoperative recovery.


 
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