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“Study on the effect of EMLA cream (lidocaine and prilocaine) in reducing throat pain after general anaesthesia: A randomised controlled study.”

Phase 4
Not yet recruiting
Conditions
Medical and Surgical,
Registration Number
CTRI/2025/04/083761
Lead Sponsor
Jeevitha V
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
122
Inclusion Criteria
  • Adult patients of either sex aged 18 to 65 years.
  • American Society of Anaesthesiologists (ASA) physical status I and II.
  • scheduled for elective surgeries with an expected duration of 1 to 3 hours under general endotracheal anesthesia.
Exclusion Criteria
  • known allergy to Local anaesthetic 2.
  • More then 2 intubation attempts 3.
  • patients with head and neck surgery involving airway.
  • preoperative sore throat 5.
  • difficult airway expected prolonged surgical duration lasting for more than 3 hours.
  • Surgeries in prone position.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 intubation10 minutes, 6 hours, 24 hours, and 48 hours post-extubation.
Secondary Outcome Measures
NameTimeMethod
To assess the severity of postoperative cough following general endotracheal intubation.10 minutes, 6 hours, 24 hours, and 48 hours post-extubation.

Trial Locations

Locations (1)

Jawaharlal Nehru Medical College, Belagavi

🇮🇳

Belgaum, KARNATAKA, India

Jawaharlal Nehru Medical College, Belagavi
🇮🇳Belgaum, KARNATAKA, India
Dr Jeevitha V
Principal investigator
9972933412
jeevitha.swaron@gmail.com

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