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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Ka Ting Ng, MBChB (Edinburgh)
- Telefonnummer: +60379492411
- E-post: katingng1@um.edu.my
Studiesteder
-
-
Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- Universiti Malaya Medical Centre
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of postoperative sore throat (POST)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Severity of POST
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 24-hour after surgery
|
NRS 0-10 (0 = not satisfy, 10 = very satisfy) |
24-hour after surgery
|
|
Adverse events of intravenous lignocaine
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Stomatognatiske sykdommer
- Sykdommer i nervesystemet
- Patologiske prosesser
- Luftveisinfeksjoner
- Infeksjoner
- Sykdommer i luftveiene
- Respirasjonsforstyrrelser
- Otorhinolaryngologiske sykdommer
- Tegn og symptomer, luftveier
- Faryngeale sykdommer
- Laryngeale sykdommer
- Stemmeforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Hoste
- Postoperative komplikasjoner
- Heshet
- Faryngitt
- Farmasøytiske preparater
- Krystalloidløsninger
- Isotoniske løsninger
- Løsninger
- Saltoppløsning
Andre studie-ID-numre
- V1.1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .