Intravenous LIGNOcaine for the POstoperative Sore Throat (LIGNO-POST)

November 9, 2026 updated by: Ka Ting Ng, University of Malaya

Intravenous LIGNOcaine for the POstoperative Sore Throat: A Double-blinded Randomised Placebo-controlled Trial (LIGNO-POST Trial)

Patients often encounter unpleasant sore throat after surgery when wake up from general anaesthesia and pulling off breathing tube. Lignocaine is a medication used in anaesthesia for the properties of analgesia and anti-inflammation. Other studies suggested that lignocaine spray/ gel can reduce the postoperative sore throat after extubation in patients undergoing surgery. However, it can reduce the gag reflex, resulting in higher risk of aspiration after surgery. Therefore, this randomized, double-blind, placebo-controlled trial is designed to determine whether giving intravenous lignocaine toward the end of the surgery before extubation can reduce postoperative sore throat and discomfort after surgery. It is hypothesized that intravenous lignocaine can reduce postoperative sore throat in patients undergoing general anaesthesia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Postoperative sore throat (POST) is a common and discomfort adverse event following general anaesthesia with orotracheal intubation, with reported incidences ranging from 30% to 70%. It is characterized by pain or discomfort at the larynx or pharynx during postoperative period in the recovery area, which can affect the overall perioperative experience and patient satisfaction. The pathophysiology of POST is believed due to mechanical trauma to the pharyngeal and laryngeal mucosa during intubation, cuff-related pressure injury, and airway inflammation that cause postoperative throat symptoms. Several non-pharmacological and pharmacological measures such as lozenges, gargles, lignocaine spray and steroid injection have been experimented with mixed findings.

Lignocaine is a local anaesthetic agent, which has the properties of analgesia and anti-inflammatory effect via the blockade of sodium channel receptor. Lignocaine spray at the throat is believed to reduce the severity of POST at various concentration (2%, 5% and 10%). However, studies reported that some of the additives agents (methanol, ethanol) in the lignocaine spray have irritating side effects to damage tracheal mucosa, negating the effect of topical lignocaine on the incidence of POST. In addition, topicalized lignocaine reduces the gag reflex if given too late before extubation, resulting in higher risk of aspiration in the recovery area.

In a routine general anaesthesia, intravenous dexamethasone is administered as an analgesic adjunct and anti-inflammatory to minimize airway edema. Administering intravenous lignocaine prior to extubation is believed to provide analgesic effect to reduce incidence of POST and postoperative cough after general anaesthesia. However, the evidence regarding its effect on POST remains limited and inconsistent, particularly when administered near the time of emergence from general anaesthesia.

Therefore, this randomized, double-blind, placebo-controlled trial is aimed to examine the use of intravenous lignocaine prior to extubation in the reduction of POST in surgical patients undergoing oral intubation during general anaesthesia in University Malaya Medical Centre.

Study Type

Interventional

Enrollment (Estimated)

398

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
        • Universiti Malaya Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18-65 years.
  • American Society of Anaesthesiologists (ASA 1-2).
  • Scheduled for elective non-airway surgery requiring general anaesthesia with orotracheal intubation of anticipated duration ≥ 90 minutes.
  • Able to understand the patient information sheet (in English or Bahasa Malaysia) and provide written informed consent.

Exclusion Criteria:

  • ASA physical status III-V.
  • Body mass index < 18 or > 40 kg/m².
  • Known hypersensitivity to amide local anaesthetics, including lignocaine.
  • Anticipated difficult airway (Mallampati III-IV, mouth opening < 3 cm, restricted neck extension, thyromental distance < 6 cm).
  • Upper respiratory tract infection within the preceding 2 weeks; chronic cough; pre-existing sore throat or hoarseness.
  • Airway, head-and-neck, dental, or thoracic surgery; surgery requiring transoesophageal echocardiography.
  • History of significant cardiac arrhythmia, second- or third-degree heart block, or hepatic impairment (Child-Pugh B or C).
  • Pregnancy or lactation.
  • Inability to perform self-report outcome assessment owing to cognitive impairment or language barrier.
  • Concurrent systemic lignocaine or anti-arrhythmic class I therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group L (lignocaine)
Drug: Intravenous lignocaine

IV lignocaine 1.5 mg/kg, calculated on lean body weight (LBW).
Placebo Comparator: Group P (placebo)
Drug: Normal Saline (0.9% NaCl)

0.9% normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative sore throat (POST)
Time Frame: 1-hour, 6-hour, 24-hour after surgery

Patient-reported pain/discomfort in throat (yes/no) on standardised question.
1-hour, 6-hour, 24-hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of POST
Time Frame: 1-hour, 6-hour, 24-hour after surgery

NRS 0-10 (0 = none, 10 = worst imaginable).
1-hour, 6-hour, 24-hour after surgery
Incidence and severity of postoperative cough
Time Frame: 1-hour, 6-hour, 24-hour after surgery

Observation of cough in post anaesthesia care unit (yes/no); 4-point scale: 0 none, 1 mild (single), 2 moderate (> 1 episode), 3 severe (constant).
1-hour, 6-hour, 24-hour after surgery
Incidence of post-extubation hoarseness
Time Frame: 1-hour, 6-hour, 24-hour after surgery

Stout's 4-point grading: 0 no hoarseness, 1 mild hoarseness (only noticed by patient), 2 severe hoarseness (noticed by medical personnel), 3 aphonia (total inability to speak)
1-hour, 6-hour, 24-hour after surgery
Patient satisfaction
Time Frame: 24-hour after surgery

NRS 0-10 (0 = not satisfy, 10 = very satisfy)
24-hour after surgery
Adverse events of intravenous lignocaine
Time Frame: During surgery and 1-hour after surgery in post anaesthesia care unit

haemodynamic events (HR < 50 or > 100, MAP < 65 or > 110); seizure, perioral numbness, dizziness, tinnitus.
During surgery and 1-hour after surgery in post anaesthesia care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 4, 2026

First Submitted That Met QC Criteria

November 9, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 9, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V1.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Requests for de-identified data from qualified researchers may be considered by the principal investigator on a case-by-case basis, subject to approval by the ethics committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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