“Study on the effect of EMLA cream (lidocaine and prilocaine) in reducing throat pain after general anaesthesia: A randomised controlled study.”
- 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
- 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.
- 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
Name Time Method 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 Measures
Name Time Method 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, IndiaDr Jeevitha VPrincipal investigator9972933412jeevitha.swaron@gmail.com