Intravenous LIGNOcaine for the POstoperative Sore Throat (LIGNO-POST)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 4
Kontakte und Standorte
Studienkontakt
- Name: Ka Ting Ng, MBChB (Edinburgh)
- Telefonnummer: +60379492411
- E-Mail: katingng1@um.edu.my
Studienorte
-
-
Kuala Lumpur
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Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- Universiti Malaya Medical Centre
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Group L (lignocaine)
|
IV lignocaine 1.5 mg/kg, calculated on lean body weight (LBW). |
|
Placebo-Komparator: Group P (placebo)
|
0.9% normal saline |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of postoperative sore throat (POST)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Severity of POST
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 24-hour after surgery
|
NRS 0-10 (0 = not satisfy, 10 = very satisfy) |
24-hour after surgery
|
|
Adverse events of intravenous lignocaine
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- El-Boghdadly K, Bailey CR, Wiles MD. Postoperative sore throat: a systematic review. Anaesthesia. 2016 Jun;71(6):706-17. doi: 10.1111/anae.13438. Epub 2016 Mar 28.
- Hung NK, Wu CT, Chan SM, Lu CH, Huang YS, Yeh CC, Lee MS, Cherng CH. Effect on postoperative sore throat of spraying the endotracheal tube cuff with benzydamine hydrochloride, 10% lidocaine, and 2% lidocaine. Anesth Analg. 2010 Oct;111(4):882-6. doi: 10.1213/ANE.0b013e3181d4854e. Epub 2010 Mar 19.
- Yang SS, Wang NN, Postonogova T, Yang GJ, McGillion M, Beique F, Schricker T. Intravenous lidocaine to prevent postoperative airway complications in adults: a systematic review and meta-analysis. Br J Anaesth. 2020 Mar;124(3):314-323. doi: 10.1016/j.bja.2019.11.033. Epub 2020 Jan 28.
- Taskin K, Geyik FD, Arslan G, Sezen O, Cevik B. Efficacy of lidocaine via trachospray in postoperative sore throat and hemodynamic response to intubation: a randomized controlled trial. BMC Anesthesiol. 2025 Mar 20;25(1):133. doi: 10.1186/s12871-025-03004-2.
- Li H, Yue Y, Qu Y, Mu D. Lidocaine for postoperative sore throat: a meta-analysis of randomized controlled trials. Minerva Anestesiol. 2020 May;86(5):546-553. doi: 10.23736/S0375-9393.20.14170-1. Epub 2020 Jan 28.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neurologische Manifestationen
- Stomatognathe Erkrankungen
- Erkrankungen des Nervensystems
- Pathologische Prozesse
- Infektionen der Atemwege
- Infektionen
- Erkrankungen der Atemwege
- Atemstörungen
- Otorhinolaryngologische Erkrankungen
- Anzeichen und Symptome, Atmung
- Rachenkrankheiten
- Kehlkopferkrankungen
- Stimmstörungen
- Pathologische Zustände, Anzeichen und Symptome
- Anzeichen und Symptome
- Husten
- Postoperative Komplikationen
- Heiserkeit
- Pharyngitis
- Pharmazeutische Präparate
- Kristalloidlösungen
- Isotonische Lösungen
- Lösungen
- Salzlösung
Andere Studien-ID-Nummern
- V1.1
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