Effect of trans-tracheal injection of local anaesthetic on post-operative sore-throat in patients undergoing breast cancer surgeries-
- Conditions
- Neoplasms,
- Registration Number
- CTRI/2020/06/025817
- Lead Sponsor
- Amrita Institute of Medical Sciences
- Brief Summary
Breast surgeries are commonly performed undergeneral anaesthesia with laryngeal mask airway. Post operatively sore-throat(POST), hoarseness and cough are common complaints following breast surgery. Eventhough these symptoms resolve spontaneously, prophylactic management of POST isrecommended to improve the quality of post-anaesthesia care. Various drugs like intravenous dexamethasone,ketamine, magnesium sulphate have been studied for their efficacy to reduce theincidence of sore-throat. Nebulization or local application of localanaesthetic has been used to reduce the development of POST [1]. Trans-tracheal administration of local anaesthetic is used in awake fiberoptic intubation.[2] Thisstudy is performed to assess the effectiveness of single dose 5ml of trans-tracheal lignocaine 4% on the incidenceof POST, hoarseness and cough.
**Methods**
This prospective, randomised, double blinded studywill be conducted after obtaining approval from hospital ethical committee, clinical trial registry of India (CTRI) and informed written consent from patients. Patients aged 18–60 years, of theAmerican Society of Anaesthesiologists (ASA) physical status 1–2, undergoingbreast cancer surgeries lasting 2-3h under general anaesthesia with laryngealmask airway will be included in this study. Patients with anticipated difficultairway, history of allergy to the test drug, who required more than oneattempt at insertion and those withpre-operative sore throat or already on analgesics or steroids (systemic orinhaled) will be excluded from the study.
Thepatients will be randomly assigned into two equal groups, T and S, based oncomputer-generated random sequence of numbers. Concealment will be achieved byclosed envelope technique. Standard general anaesthesia protocol will befollowed in both groups. Patients will receive oral ranitidine150 mg, metoclopramide10 mg, and alprazolam 0.25 mg on the night before surgeryand ranitidine 150 mg and metoclopramide 10 mg on the morning of
surgery.
Inthe operation theatre, intravenous (IV) cannula will be inserted and monitoringwith electrocardiography, noninvasive blood pressure monitor, and pulse oximeter will be done. Patientsin group T will receive a trans-tracheal injection of 5ml of 4% lignocaine andgroup S will receive a trans-tracheal injection of 5ml of 0.9% saline. Patientswill be pre oxygenated with 100% O2; glycopyrrolate 0.2 mg, midazolam2 mg and fentanyl 2 µg/kg will be given intravenously. They will then be induced with IV propofol1.5–2.5 mg/kg till there is loss of response to verbal command and the patientbecomes apnoeic. Classic LMA size 3/4 will be inserted after full deflation. The patient will be maintained on O2, N2O and isoflurane 0.5%–1.5%. LMAcuffs will be filled with 20/30 ml of room air. If >1attempt will berequired for insertion, the patients will be excluded from the study.
The trans-tracheal injection will be given by a single consultant anaesthetist. The cuff pressurewill be measured and will be set to 25 cmH2O using Portex cuff inflator(manufacturer: Smiths Medical International Ltd., UK) in both groups. Patientswill be maintained on spontaneous ventilation. Rise in heart rate and/or meanarterial pressure more than 20% from the baseline value will be initiallytreated with increasing the inspired concentration of isoflurane to 1.5%–2%. Ifthere was no response, IV 20 μg boluses of fentanyl will be given.Toward the end of the surgery, IV ondansetron 4 mg and IV paracetamol 1 g will begiven to all patients. On completion of the surgery, LMA will be removed aftersuctioning and deflating the cuff. Four hours after surgery all patients willreceive oral paracetamol 650 mg 8th hourly. Patients will be given rescueanalgesia with IV tramadol 1mg.kg−1 if the patient complained of pain. Thetotal dose of tramadol given in the first 24 h will be noted for both groups. Postoperative sore throat,cough and hoarseness will be monitored by the anaesthetist who will be blinded andthe responses will be noted at 0, 2, 4, 12, and 24 h.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 50
Patients aged 18–60 years, of the American Society of Anaesthesiologists (ASA) physical status 1–2, undergoing breast cancer surgeries lasting 2-3h under general anaesthesia with laryngeal mask airway.
Patients with an anticipated difficult airway, history of allergy to the test drug, who required more than one attempt at insertion and those with pre-operative sore throat or already on analgesics or steroids (systemic or inhaled).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary objective is to assess the reduction in incidence and severity of postoperative sore throat. Post operative period upto 24 h
- Secondary Outcome Measures
Name Time Method Secondary objectives include reduction in incidence of postoperative hoarseness of voice and cough. Post operative period upto 24 h
Trial Locations
- Locations (1)
Amrita Institute of medical Sciences
🇮🇳Ernakulam, KERALA, India
Amrita Institute of medical Sciences🇮🇳Ernakulam, KERALA, IndiaNitu PVPrincipal investigator09495962020nituveesundeep@gmail.com